JMIR Research Protocols

Ongoing Trials, Grant Proposals, Formative Research, Methods, Early Results

Secondary care clinic for chronic disease – Research protocol

Background: The complexity of chronic disease management activities and the associated financial burden have prompted the development of organisational models based on the integration of care and services and relying on primary care services. However, since the institutions providing these services are continually undergoing reorganisation, the Centre hospitalier affilié universitaire de Québec wanted to innovate by adapting the Chronic Care Model to create a clinic for the integrated follow-up of chronic disease that relies on hospital-based specialty care. Objective: The aim of the study is to follow the project in order to contribute to knowledge about the way in which professional and management practices are organised to ensure better care coordination and the successful integration of the various follow-ups implemented. Methods: The research strategy adopted is based on the longitudinal comparative case study with embedded units of analysis. The case study uses a mixed research method. Results: The results are not available at this time. We are actually in the analysis phase of the project. The results will be available in 2015. Conclusions: The project’s originality lies in its consideration of the macro, meso and micro contexts structuring the creation of the clinic in order to ensure the integration process is successful and to allow a theoretical generalization of the reorganisation of practices to be developed.

2013-04-27

JMIR Res Protoc articles are indexed in PubMed (http://www.ncbi.nlm.nih.gov/pubmed/?term=JMIR+Res+Protoc) and the full text is immediately deposited in PubMed Central (http://www.ncbi.nlm.nih.gov/pmc/journals/2066/). JMIR Res Protoc adheres to the same quality standards as JMIR and all articles published here are also cross-listed in the Table of Contents of JMIR, the worlds' leading medical journal in health sciences / health services research and health informatics (http://www.jmir.org/issue/current).

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Journal Description

 

JMIR Research Protocols (ISSN 1929-0748) publishes peer-reviewed, openly accessible research ideas and grant proposals, study and trial protocols, reports of ongoing research, current methods and approaches, and preliminary results from pilot studies or formative research informing the design of medical and health-related research and technology innovations.

  • JMIR Res Protoc is a new journal spin-off of JMIR, the worlds' leading medical journal in health sciences / health services research and health informatics (Impact Factor: 4.7)
  • JMIR Res Protoc publishes protocols and grant proposals in all areas of medicine (and their peer-review reports, if available), as well as feasibility studies, early reports and formative/process evaluations of ongoing studies and descriptions of the development and pilot evaluations of innovations and software applications or other interventions
  • JMIR Res Protoc is fully open access, with full text articles deposited in PubMed Central
  • Publishing research protocols, grant proposals, pilot/feasibility studies and early reports of ongoing and planned work encourages collaboration and early feedback, and reduces duplication of effort 
  • JMIR Res Protoc will be a valuable ressource for researchers who want to learn about current research methodologies and how to write a winning grant proposal
  • JMIR Res Protoc creates an early scientific record for researchers who have developed novel methodologies, software, innovations or elaborate protocols
  • JMIR Res Protoc faciliates subsequent publication of results demonstrating that the methodology has already been reviewed, and reduces the effort of writing up the results, as the protocol can be easily referenced
  • JMIR Res Protoc demonstrates to reviewers of subsequent results papers that authors followed and adhered to carefully developed and described a-priori methods
  • Studies whose protocols or grant proposal have been accepted in JMIR Res Protoc are "in principle accepted" for subsequent publication of results in other JMIR journals as long as authors adhere to their original protocol - regardless of study results (even if they are negative), reducing publication bias in medicine
  • Authors publishing their protocols in JMIR Res Protoc will receive a 20% discount on the article processing fee if they publish their results in another journal of the JMIR journal family (for example, JMIR for ehealth studies, i-JMR for others)
 
 

Recent Articles:

  • A Virtual World Versus Face-to-Face Intervention Format to Promote Diabetes Self-Management Among African American Women: A Pilot Randomized Clinical Trial

    Abstract:

    Background: Virtual world environments have the potential to increase access to diabetes self-management interventions and may lower cost. Objective: We tested the feasibility and comparative effectiveness of a virtual world versus a face-to-face diabetes self-management group intervention. Methods: We recruited African American women with type 2 diabetes to participate in an 8-week diabetes self-management program adapted from Power to Prevent, a behavior-change in-person group program for African Americans with diabetes or pre-diabetes. The program is social cognitive theory–guided, evidence-based, and culturally tailored. Participants were randomized to participate in the program via virtual world (Second Life) or face-to-face, both delivered by a single intervention team. Blinded assessors conducted in-person clinical (HbA1c), behavioral, and psychosocial measurements at baseline and 4-month follow-up. Pre-post differences within and between intervention groups were assessed using t tests and chi-square tests (two-sided and intention-to-treat analyses for all comparisons). Results: Participants (N=89) were an average of 52 years old (SD 10), 60% had ≤high school, 82% had household incomes P=.90). Compared to face-to-face, virtual world was slightly superior for total activity, light activity, and inactivity (P=.05, P=.07, and P=.025, respectively). HbA1c reduction was significant within face-to-face (−0.46, P=02) but not within virtual world (−0.31, P=.19), although there were no significant between group differences in HbA1c (P=.52). In both groups, 14% fewer patients had post-intervention HbA1c ≥9% (virtual world P=.014; face-to-face P=.002), with no significant between group difference (P=.493). Compared to virtual world, face-to-face was marginally superior for reducing depression symptoms (P=.051). The virtual world intervention costs were US $1117 versus US $931 for face-to-face. Conclusions: It is feasible to deliver diabetes self-management interventions to inner city African American women via virtual worlds, and outcomes may be comparable to those of face-to-face interventions. Further effectiveness research is warranted. Clinical Trial: ClinicalTrials.gov NCT01340079; http://clinicaltrials.gov/show/NCT01340079 (Archived by WebCite at http://www.webcitation.org/6T2aSvmka).
  • Sibanye Methods for Prevention Packages Program Project Protocol: Pilot Study of HIV Prevention Interventions for Men Who Have Sex With Men in South Africa

    Abstract:

    Background: Human immunodeficiency virus (HIV) prevention intervention programs and related research for men who have sex with men (MSM) in the southern African region remain limited, despite the emergence of a severe epidemic among this group. With a lack of understanding of their social and sexual lives and HIV risks, and with MSM being a hidden and stigmatized group in the region, optimized HIV prevention packages for southern African MSM are an urgent public health and research priority. Objective: The objective of the Sibanye Health Project is to develop and evaluate a combination package of biomedical, behavioral, and community-level HIV prevention interventions and services for MSM in South Africa. Methods: The project consists of three phases: (1) a comprehensive literature review and summary of current HIV prevention interventions (Phase I), (2) agent-based mathematical modeling of HIV transmission in southern African MSM (Phase II), and (3) formative and stigma-related qualitative research, community engagement, training on providing health care to MSM, and the pilot study (Phase III). The pilot study is a prospective one-year study of 200 men in Cape Town and Port Elizabeth, South Africa. The study will assess a package of HIV prevention services, including condom and condom-compatible lubricant choices, risk-reduction counseling, couples HIV testing and counseling, pre-exposure prophylaxis (PrEP) for eligible men, and non-occupational post-exposure prophylaxis for men with a high risk exposure. The pilot study will begin in October 2014. Results: Preliminary results from all components but the pilot study are available. We developed a literature review database with meta-data extracted from 3800 documents from 67 countries. Modeling results indicate that regular HIV testing and promotion of condom use can significantly impact new HIV infections among South African MSM, even in the context of high coverage of early treatment of HIV-positive men and high coverage of PrEP for at-risk HIV-negative men. Formative qualitative research consisted of 79 in-depth interviews, and six focus group discussions in Cape Town and Port Elizabeth. Analysis of these data has informed pilot study protocol development and has been documented in peer-reviewed manuscripts. Qualitative work regarding stigma faced by South African MSM resulted in finalized scales for use in the pilot study questionnaire. A total of 37 health care providers completed training designed to facilitate clinically and culturally competent care for MSM in the Eastern Cape. Conclusions: The design of a future, larger study of the HIV prevention package will be conducted at the end of the pilot study, powered to detect efficacy of the prevention package. Data from the updated mathematical model, results of the pilot study, acceptability data, and advancements in HIV prevention sciences will be considered in developing the final proposed package and study design. Trial Registration: ClinicalTrials.gov NCT02043015; http://clinicaltrials.gov/show/NCT02043015 (Archived by WebCite at http://www.webcitation.org/6THvp7rAj).
  • Development and Validation of Questionnaires Exploring Health Care Professionals' Intention to Use Wiki-Based Reminders to Promote Best Practices in Trauma

    Abstract:

    Background: Little is known about factors influencing professionals’ use of wikis. Objective: We developed and validated two questionnaires to assess health care professionals’ intention to use wiki-based reminders for the management of trauma patients. Methods: We developed questionnaires for emergency physicians (EPs) and allied health professions (AHPs) based on the Theory of Planned Behavior and adapted them to the salient beliefs of each, identified in an earlier study. Items measured demographics and direct and indirect theoretical constructs. We piloted the questionnaires with 2 focus groups (5 EPs and 5 AHPs) to identify problems of wording and length. Based on feedback, we adjusted the wording and combined certain items. A new convenience sample of 25 EPs and 26 AHPs then performed a test-retest of the questionnaires at a 2-week interval. We assessed internal consistency using Cronbach alpha coefficients and temporal stability of items with an agreement intraclass correlation coefficient (ICC). Results: Five EPs and 5 AHPs (3 nurses, 1 respiratory therapist, and 1 pharmacist) formed 2 focus groups; 25 EPs and 26 AHPs (12 nurses, 7 respiratory therapists, and 7 pharmacists) completed the test and retest. The EP questionnaire test-retest scores for consistency (Cronbach alpha) and stability (ICC) were intention (test: Cronbach alpha=.94; retest: Cronbach alpha=.98; ICC=.89), attitude (.74, .72, .70), subjective norm (.79, .78, .75), perceived behavioral control (.67, .65, .66), attitudinal beliefs (.94, .86, .60), normative beliefs (.83, .87, .79), and control beliefs barriers (.58, .67, .78) and facilitators (.97, .85, .30). The AHP questionnaire scores for consistency and stability were: intention (test Cronbach alpha=.69, retest Cronbach alpha=.81, ICC=.48), attitude (.85, .87, .83), subjective norm (.47, .82, .62), perceived behavioral control (.55, .62, .60), attitudinal beliefs (.92, .91, .82), normative beliefs (.85, .90, .74), and control beliefs barriers (.58, .55, .66) and facilitators (.72, .94, –.05). To improve the psychometric properties of both questionnaires, we reformulated poorly consistent or unstable items. Conclusions: Our new theory-based questionnaires to measure health care professionals’ intention to use wiki-based reminders have adequate validity and reliability for use in large surveys. In the long run, they can be used to develop a theory-based implementation intervention for a wiki promoting best practices in trauma care.
  • Effect of Web-Based Messages on Girls’ Knowledge and Risk Perceptions Related to Cigarette Smoke and Breast Cancer: 6-Month Follow-Up of a Randomized...

    Abstract:

    Background: Evidence indicating an association between cigarette smoke exposure and an increase in breast cancer risk highlights the need for health messages that aim to prevent smoking initiation and reduce secondhand smoke (SHS) exposure among adolescent girls. Objective: This study aimed to evaluate the efficacy of targeted gender-sensitive, breast cancer-specific, Web-based messages about the increased risk of breast cancer associated with cigarette smoke exposure. Outcomes assessed 6 months postmessage delivery included nonsmoking adolescent girls’ knowledge of the link between cigarette smoke exposure and breast cancer, perceptions of breast cancer risk associated with cigarette smoke, smoking behavior and intentions, and stage of change related to avoidance of secondhand smoke. Methods: A prospective randomized controlled trial was used to compare standard (control) messages with targeted gender- and Aboriginal status-sensitive, breast cancer-specific (intervention) messages. Messages were delivered online to 618 nonsmoking girls, aged 13 to 15 years, clustered in 74 Canadian secondary schools. Results: Compared with the control group, girls in the intervention group were significantly more likely to report that breast cancer is an illness caused by cigarette smoke (adjusted relative risk [ARR] 1.33, 95% CI 1.05-1.68) and to agree that exposure to SHS increases their risk of breast cancer (ARR 1.10, 95% CI 1.02-1.20). No significant effects were observed for a change in smoking status, intention to try smoking, or stage of change related to avoidance of SHS. Conclusions: Compared with standard messages, targeted gender-sensitive, breast cancer-specific messages had a stronger influence on girls’ knowledge and perceived risk of cigarette smoke exposure as a risk factor for breast cancer. Brief information-based interventions delivered over the Internet have the potential to provide effective health promotion that could be broadly disseminated and lead to long-term effects on girls’ knowledge and risk perceptions about cigarette exposure and breast cancer.
  • Long Working Hours and Subsequent Use of Psychotropic Medicine: A Study Protocol

    Abstract:

    Background: Mental ill health is the most frequent cause of long-term sickness absence and disability retirement in Denmark. Some instances of mental ill health might be due to long working hours. A recent large cross-sectional study of a general working population in Norway found that not only “very much overtime”, but also “moderate overtime” (41-48 work hours/week) was significantly associated with increased levels of both anxiety and depression. These findings have not been sufficiently confirmed in longitudinal studies. Objective: The objective of the study is to give a detailed plan for a research project aimed at investigating the possibility of a prospective association between weekly working hours and use of psychotropic medicine in the general working population of Denmark. Methods: People from the general working population of Denmark have been surveyed, at various occasions in the time period 1995-2010, and interviewed about their work environment. The present study will link interview data from these surveys to national registers covering all inhabitants of Denmark. The participants will be followed for the first occurrence of redeemed prescriptions for psychotropic medicine. Poisson regression will be used to analyze incidence rates as a function of weekly working hours (32-40; 41-48; > 48 hours/week). The analyses will be controlled for gender, age, sample, shift work, and socioeconomic status. According to our feasibility studies, the statistical power is sufficient and the exposure is stable enough to make the study worth the while. Results: The publication of the present study protocol ends the design phase of the project. In the next phase, the questionnaire data will be forwarded to Statistics Denmark where they will be linked to data on deaths, migrations, socioeconomic status, and redeemed prescriptions for psychotropic medication. We expect the analysis to be completed by the end of 2014 and the results to be published mid 2015. Conclusions: The proposed project will be free from hindsight bias, since all hypotheses and statistical models are completely defined, peer-reviewed, and published before we link the exposure data to the outcome data. The results of the project will indicate to what extent and in what direction the national burden of mental ill health in Denmark has been influenced by long working hours.
  • Enhancing Parental Motivation to Monitor African American Adolescents’ Diabetes Care: Development and Beta Test of a Brief Computer-Delivered Intervention

    Abstract:

    Background: African American youth are at increased risk for poor diabetes management. Parenting behaviors such as parental monitoring are significant predictors of youth diabetes management and metabolic control, but no intervention has targeted parental monitoring of daily diabetes care. Objective: The purpose of the present study was to develop and pilot test a three-session computer-delivered intervention to enhance parental motivation to monitor African American pre-adolescents’ diabetes management. Methods: The 3 Ms (Medication, Meter, and Meals) intervention was based on the Information-Motivation-Behavioral Skills (IMB) model of health behavior change and Motivational Interviewing approaches. Five caregivers of African American youth aged 10-13 years diagnosed with type 1 diabetes for a minimum of one year (ie, the target population) reviewed the intervention and provided feedback via semi-structured interviews. Interviews were transcribed and analyzed using thematic analysis. Results: Caregivers’ responses to interview questions suggest that The 3 Ms was helpful (minimum rating was 8 out of 10) and they would recommend the program to another parent of a child with diabetes (minimum rating was 9 out of 10). Three of five reported that The 3 Ms program increased the likelihood that they would talk to their child about diabetes. Thematic analysis suggested two primary themes: caregivers found the intervention to be a useful reminder of the importance of supervising their child’s diabetes care and that it evoked a feeling of shared experience with other parents. Conclusions: The 3 Ms computer-delivered intervention for increasing parental monitoring of African-American youth with type 1 diabetes was well-received and highly rated by a small sample of representative caregivers. Trial Registration: ClinicalTrials.gov NCT01515930; http://clinicaltrials.gov/ct2/show/NCT01515930 (Archived by WebCite at http://www.webcitation.org/6Rm0vq9pn).
  • Social Networking Versus Facebook Advertising to Recruit Survey Respondents: A Quasi-Experimental Study

    Abstract:

    Background: Increasingly, social contact and knowledge of other people’s attitudes and behavior are mediated by online social media such as Facebook. The main research to which this recruitment study pertains investigates the influence of parents on adolescent alcohol consumption. Given the pervasiveness of online social media use, Facebook may be an effective means of recruitment and intervention delivery. Objective: The objective of the study was to determine the efficacy of study recruitment via social networks versus paid advertising on Facebook. Methods: We conducted a quasi-experimental sequential trial with response rate as the outcome, and estimates of cost-effectiveness. The target population was parents of 13-17 year old children attending high schools in the Hunter region of New South Wales, Australia. Recruitment occurred via: method (1) social recruitment using Facebook, email-based, social networks, and media coverage followed by method (2) Facebook advertising. Results: Using a range of online and other social network approaches only: method (1) 74 parents were recruited to complete a survey over eight months, costing AUD58.70 per completed survey. After Facebook advertising: method (2) 204 parents completed the survey over four weeks, costing AUD5.94 per completed survey. Participants were representative of the parents recruited from the region’s schools using standard mail and email. Conclusions: Facebook advertising is a cost-effective means of recruiting parents, a group difficult to reach by other methods.
  • Community-Based Rehabilitation Post Hospital Discharge Interventions for Older Adults With Cognitive Impairment Following a Hip Fracture: A Systematic Review...

    Abstract:

    Background: Hip fractures among older adults remain a public concern. Consequences of a hip fracture include the subsequent decline in function and mobility for the older adult, and an increased burden placed upon their caregivers and the health care system. The consequences may be more challenging if an older adult also has a compromised cognitive reserve. Although rehabilitation programs have proven effective, the best practices and resources required to maintain the gains in function and mobility, to negate diminution of effect, and to enable this patient population to continue living at home are currently unknown. Objective: The objective of this study is to develop a systematic review protocol focused on identifying the evidence and evaluating the effectiveness of post discharge rehabilitation programs for older adults with a cognitive impairment following a hip fracture. Methods: The search strategy will include a combination of text words and subject headings relating to the concepts of cognitive impairment, dementia, delirium, cognitive reserve, and hip fractures. Searching various databases will identify peer-reviewed journal articles. There will be two independent reviewers who will screen the titles and abstracts to determine which articles comprise a rehabilitation intervention within a community setting prior to being included for a full article review. A data extraction form and an evidence and quality checklist will be used during the full article data analysis and synthesis. It is expected that there will be a paucity of studies that focus on post discharge rehabilitation interventions for older adults with cognitive impairment following a hip fracture, and few studies that use the same or similar outcome measures. However, if possible, a meta-analysis will be conducted on studies that used similar outcome methods. Results: This review will synthesize knowledge focusing on activities to maintain and restore function in older adult patients with cognitive impairment once they have completed their active rehabilitation program and return home. A synthesis of the findings will be conducted to determine which components of the interventions identified were the most advantageous to the patient population. The results will be used to develop a multi-faceted post discharge rehabilitation intervention aimed at enabling older adults to return and remain living at home after a hip fracture. Conclusions: The aim of this systematic review is to generate results that can be used to create interventions that focus on the care necessary to enable older adults to remain living at home post discharge from acute or inpatient rehabilitation care for a hip fracture. With the support and contributions by our associated knowledge users, this systematic review will be used to help inform procedures and policies to facilitate the necessary care and resources required by our patient population.
  • A Web-Based Program for Informal Caregivers of Persons With Alzheimer’s Disease: An Iterative User-Centered Design

    Abstract:

    Background: Web-based programs have been developed for informal caregivers of people with Alzheimer’s disease (PWAD). However, these programs can prove difficult to adopt, especially for older people, who are less familiar with the Internet than other populations. Despite the fundamental role of usability testing in promoting caregivers’ correct use and adoption of these programs, to our knowledge, this is the first study describing this process before evaluating a program for caregivers of PWAD in a randomized clinical trial. Objective: The objective of the study was to describe the development process of a fully automated Web-based program for caregivers of PWAD, aiming to reduce caregivers’ stress, and based on the user-centered design approach. Methods: There were 49 participants (12 health care professionals, 6 caregivers, and 31 healthy older adults) that were involved in a double iterative design allowing for the adaptation of program content and for the enhancement of website usability. This process included three component parts: (1) project team workshops, (2) a proof of concept, and (3) two usability tests. The usability tests were based on a mixed methodology using behavioral analysis, semistructured interviews, and a usability questionnaire. Results: The user-centered design approach provided valuable guidelines to adapt the content and design of the program, and to improve website usability. The professionals, caregivers (mainly spouses), and older adults considered that our project met the needs of isolated caregivers. Participants underlined that contact between caregivers would be desirable. During usability observations, the mistakes of users were also due to ergonomics issues from Internet browsers and computer interfaces. Moreover, negative self-stereotyping was evidenced, when comparing interviews and results of behavioral analysis. Conclusions: Face-to-face psycho-educational programs may be used as a basis for Web-based programs. Nevertheless, a user-centered design approach involving targeted users (or their representatives) remains crucial for their correct use and adoption. For future user-centered design studies, we recommend to involve end-users from preconception stages, using a mixed research method in usability evaluations, and implementing pilot studies to evaluate acceptability and feasibility of programs.
  • Designing Clinically Valuable Telehealth Resources: Processes to Develop a Community-Based Palliative Care Prototype

    Abstract:

    Background: Changing population demography and patterns of disease are increasing demands on the health system. Telehealth is seen as providing a mechanism to support community-based care, thus reducing pressure on hospital services and supporting consumer preferences for care in the home. Objective: This study examined the processes involved in developing a prototype telehealth intervention to support palliative care patients involved with a palliative care service living in the community. Methods: The challenges and considerations in developing the palliative care telehealth prototype were reviewed against the Center for eHealth Research (CeHRes) framework, a telehealth development model. The project activities to develop the prototype were specifically mapped against the model’s first four phases: multidisciplinary project management, contextual inquiry, value specification, and design. This project has been developed as part of the Telehealth in the Home: Aged and Palliative Care in South Australia initiative. Results: Significant issues were identified and subsequently addressed during concept and prototype development. The CeHRes approach highlighted the implicit diversity in views and opinions among participants and stakeholders and enabled issues to be considered, resolved, and incorporated during design through continuous engagement. Conclusions: The CeHRes model provided a mechanism that facilitated “better” solutions in the development of the palliative care prototype by addressing the inherent but potentially unrecognized differences in values and beliefs of participants. This collaboration enabled greater interaction and exchange among participants resulting in a more useful and clinically valuable telehealth prototype.
  • Heavy Lifting at Work and Risk of Ischemic Heart Disease: Protocol for a Register-Based Prospective Cohort Study

    Abstract:

    Background: There are theoretical grounds to suspect that heavy lifting at work is an important risk factor for ischemic heart disease (IHD). However the relationship has not been sufficiently acknowledged by empirical studies. Positive and statistically significant associations have been found in studies that utilize self-reported exposure data. Such studies are, however, prone to reporting bias. All else equal, people with a poor cardiovascular fitness/health may have a higher propensity to perceive their work environment as heavy. Objective: The study described in the present protocol aims to investigate the relationship between heavy lifting at work and IHD by use of material and methods that are free from reporting bias. Methods: This is a register-based prospective cohort study. Male blue-collar workers in Denmark will be identified and followed through national registers, from 2001-2010, for hospital treatment or death due to IHD. Relative rates of IHD between “workers in occupations likely to involve heavy lifting” and “other blue-collar workers” will be estimated through Poisson regression. Results: Results are expected to be ready in mid-2015. Conclusions: Since this is not a randomized study, it cannot confirm etiological hypotheses. It may, however, confirm that employment in occupations that involve heavy lifting is a predictor for IHD and thereby lend support to the hypothesis of a causal relationship.
  • Diet, Physical Activity, Lifestyle Behaviors, and Prevalence of Childhood Obesity in Irish Children: The Cork Children’s Lifestyle Study Protocol

    Abstract:

    Background: Childhood obesity is complex, and its aetiology is known to be multifaceted. The contribution of lifestyle behaviors, including poor diet and physical inactivity, to obesity remains unclear. Due to the current high prevalence, childhood obesity is an urgent public health priority requiring current and reliable data to further understand its aetiology. Objective: The objective of this study is to explore the individual, family, and environmental factors associated with childhood overweight and obesity, with a specific focus on diet and physical activity. A secondary objective of the study is to determine the average salt intake and distribution of blood pressure in Irish children. Methods: A cross-sectional survey was conducted of children 8-11 years old in primary schools in Cork, Ireland. Urban schools were selected using a probability proportionate to size sampling strategy, and a complete sample of rural schools from one area in Cork County were invited to participate. Information collected included physical measurement data (anthropometric measurements, blood pressure), early morning spot and 24 hour urine samples, a 3 day estimated food diary, and 7 days of accelerometer data. Principal- (school head) reported, parent/guardian-reported, and child-reported questionnaires collected information on lifestyle behaviors and environmental attributes. The Cork Children’s Lifestyle Study (CCLaS) was designed by the Department of Epidemiology and Public Health in University College Cork, Ireland in 2011 and 2012. Piloting and modification of study methods was undertaken. Data collection took place between April 2012 and June 2013. Results: Overall, 27/46 schools and 1075/1641 children, of which 623 were boys, participated. Preliminary data analysis is underway. It is anticipated that the results of the CCLaS study will be available in late 2014. Conclusions: The CCLaS study has collected in-depth data on a wide range of individual, family, social, and environmental correlates which will allow us to access multilevel influences on childhood obesity. This study will contribute to the evidence base by highlighting current knowledge and gaps regarding the predominant drivers of childhood obesity.

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  • Secondary care clinic for chronic disease – Research protocol

    Date Submitted: Oct 20, 2014

    Open Peer Review Period: Oct 22, 2014 - Nov 5, 2014

    Background: The complexity of chronic disease management activities and the associated financial burden have prompted the development of organisational models based on the integration of care and serv...

    Background: The complexity of chronic disease management activities and the associated financial burden have prompted the development of organisational models based on the integration of care and services and relying on primary care services. However, since the institutions providing these services are continually undergoing reorganisation, the Centre hospitalier affilié universitaire de Québec wanted to innovate by adapting the Chronic Care Model to create a clinic for the integrated follow-up of chronic disease that relies on hospital-based specialty care. Objective: The aim of the study is to follow the project in order to contribute to knowledge about the way in which professional and management practices are organised to ensure better care coordination and the successful integration of the various follow-ups implemented. Methods: The research strategy adopted is based on the longitudinal comparative case study with embedded units of analysis. The case study uses a mixed research method. Results: The results are not available at this time. We are actually in the analysis phase of the project. The results will be available in 2015. Conclusions: The project’s originality lies in its consideration of the macro, meso and micro contexts structuring the creation of the clinic in order to ensure the integration process is successful and to allow a theoretical generalization of the reorganisation of practices to be developed.

  • Pain Management in Cancer Patients using a Mobile Application: Study Design of a Randomized Controlled Trial

    Date Submitted: Oct 20, 2014

    Open Peer Review Period: Oct 21, 2014 - Oct 30, 2014

    Background: Despite the availability of effective medications and clinical guidelines for pain management, pain control is sub-optimal in a sizeable proportion of patients with cancer pain. The Nation...

    Background: Despite the availability of effective medications and clinical guidelines for pain management, pain control is sub-optimal in a sizeable proportion of patients with cancer pain. The National Comprehensive Cancer Network guidelines recommend a comprehensive and multimodal approach for management of cancer pain. We developed a smartphone application based on clinical guidelines, ePAL, to empower patients for self-management and report symptom exacerbations and facilitate timely feedback from the care team. Objective: The objective of this study is to evaluate the effect of a multi-dimensional smartphone-based pain management application, ePAL, in controlling cancer pain and improving quality of life in patients with cancer pain being treated at an academic palliative care clinic. Methods: The study will be implemented as a 2-arm randomized controlled trial with 110 adult patients with CP who own a smartphone over a follow-up period of two months. Participants will be randomized to either the intervention group receiving ePAL and usual care or to a control group receiving only usual care. The brief pain inventory will be used to assess our primary outcome which is pain intensity. We will also evaluate the effect of the intervention on secondary outcomes which include the effect of the intervention on hospital utilization for pain crises, quality of life, adherence to analgesic medications, barriers to pain control, anxiety and patient engagement. Instruments that will be used in evaluating secondary outcomes include the Brief Pain Inventory, Morisky Medication Adherence Scale, Barriers Questionnaire-II, Functional Assessment of Cancer Therapy–General, Edmonton Symptom Assessment System, Generalized Anxiety Disorder 7-item scale, and the Functional Assessment of Chronic Illness Therapy-Fatigue. The intention-to-treat approach will be used to evaluate outcomes. Continuous outcomes will be compared between control and interventions using the t-test or Wilcoxon rank test and categorical variables will be compared using chi-square tests. Multivariable regression analyses will be performed to control for baseline factors independently associated with pain intensity. Results: Study in progress. Conclusions: The multi-dimensional approach to pain management implemented on a mobile phone application could lead to significant improvements in patient outcomes Clinical Trial: ClinicalTrials.gov NCT02069743

  • Feasibility of a website and a hospital based online portal for young adults with juvenile idiopathic arthritis: views and experiences of patients

    Date Submitted: Oct 17, 2014

    Open Peer Review Period: Oct 17, 2014 - Oct 31, 2014

    Background: To improve knowledge and to encourage active involvement of young adults with Juvenile Idiopathic Arthritis, an informative website with written and video information and an online portal...

    Background: To improve knowledge and to encourage active involvement of young adults with Juvenile Idiopathic Arthritis, an informative website with written and video information and an online portal with access to the personal medical record, self-monitoring and eConsult functionalities were developed. Before implementing these application in daily practice, it is important to gain insight of their feasibility in terms of ease of use, perceived usefulness and intention to use. Objective: To evaluate and to examine the feasibility of the website and the online portal for young adults with JIA. Methods: A qualitative, feasibility study was conducted among the first users: 13 young adults with Juvenile Idiopathic Arthritis (JIA). After provided access to the eHealth applications, patients were interviewed on perceived usefulness, ease of use and intention to (re-)use the applications. Results: Participants in the study considered the eHealth applications as useful and easy to use. New medical information and feedback motivated them to revisit the applications again. On the website, videos showing other young adults telling how they handle their condition were appreciated as most useful. On the portal, access to their medical records was appreciated best: it made the young JIA patients feel to be in control and it helped them monitoring symptoms and disease activity. eConsults were thought to facilitate communication with physicians. Conclusions: Feasibility testing and involvement of the end-users in development of and research on eHealth applications are valuable steps, prior to implementation in daily practice. Further research is needed of effects of the website and portal on patient outcomes.