The Smartphone Peer Physical Activity Counseling (SPPAC) Program for Manual Wheelchair Users: Protocol of a Pilot Randomized Controlled Trial

Background Physical activity (PA) must be performed regularly to accrue health benefits. However, the majority of manual wheelchair users do not meet PA recommendations. Existing community-based PA programs for manual wheelchair users appear to work, but effect sizes are small and retention is low. Existing PA programs may not fully implement some psychosocial factors that are strongly linked with PA (eg, autonomy). The use of peers and mobile phone technology in the Smartphone Peer PA Counseling (SPPAC) program represents a novel approach to cultivating a PA-supportive environment for manual wheelchair users. Objective The primary objective is to compare change in objective PA between the experimental (SPPAC) and control groups from baseline to postintervention (10 weeks) and follow-up (3 months). Changes in and relationships between subjective PA, wheelchair skills, motivation, self-efficacy (for overcoming barriers to PA for manual wheelchair use), satisfaction of psychological needs for PA, and satisfaction with PA participation will be explored (secondary outcome). Program implementation will be explored (tertiary objective). Methods A total of 38 community-living manual wheelchair users (≥18 years) will be recruited in a randomized controlled trial (RCT). Participants in both the control and experimental groups will receive existing PA guidelines. Participants in the experimental group will also receive the SPPAC program: 14 sessions (~30 min) over a 10-week period delivered by a peer trainer using a mobile phone. PA activities will be based on individuals’ preferences and goals. Implementation of important theoretical variables will be enforced through a peer-trainer checklist. Outcomes for objective PA (primary) and subjective PA, wheelchair skills, motivation, self-efficacy, satisfaction of psychological needs, and satisfaction with participation will be collected at three time points (baseline, postintervention, follow-up). Multiple imputations will be used to treat missing data. A mixed-model ANCOVA will be conducted, controlling for covariates (primary and secondary objectives). The strength and direction of the relationships between the primary and secondary outcomes will be explored (secondary objective). Descriptive and content analysis will be used to appraise program implementation (tertiary objective). Results Funding has been obtained from the Craig Neilsen Foundation and the Canadian Disability Participation Project, with additional funds being sought from the Canadian Institute for Health Research and Fonds de Recherche du Québec-Santé. Pilot evaluation of intervention implementation is currently underway, with enrollment anticipated to begin early 2018. Conclusions There may be substantial benefits for the SPPAC program including limited burden on health care professionals, decreased barriers (eg. accessibility, transportation), development of peer social supports, and potential cost savings related to physical inactivity. Before conducting a large and expensive multisite RCT within a small heterogeneous population of manual wheelchair users, a pilot study affords a prudent step to establishing an adequate study protocol and implementation strategies. Trial Registration ClinicalTrials.gov NCT02826707; https://clinicaltrials.gov/ct2/show/NCT02826707 (Archived by WebCite at http://www.webcitation.org/6pqIc14dU)

Je m'engage à faire valoir la contribution financière du FRQS dans toute publication et document officiels réalisés grâce à cet octroi. CHNF has conditionally approved funding of this proposal. Please see the reviewer comments for a listing of the strengths and weaknesses identified in your application. The following issue(s) deserve particular attention: The proposed Smartphone-based Peer Counseling (SPC) program takes an interesting but simple, cost-effective approach to the complicated health problem of physical inactivity. While the technology is not entirely novel, reviewers noted that demonstrating the feasibility and potential effect of SPC through this project could justify a larger multisite study. While the study was ambitious, the applicant is well qualified, and the research design is logical and justified. The primary and secondary mentors identified in the training plan are both highly regarded in the field and will provide complementary expertise and training. Overall, the project will support the Fellow's growth as an independent and productive researcher in the field of PSR and SCI. Reviewers had two main concerns about the training plan: 1) To strengthen the Fellowship experience, it was strongly recommended that the training plan be updated to include additional coursework on the psychological aspects of peer counseling, motivation and self-efficacy; and 2) Additional detail about the different training roles of the two mentors needs to be added. As part of the due diligence process, the applicant is asked to address these two concerns and submit an updated training plan for programmatic approval.

Reviewer Role: Primary (237823)
OVERALL IMPACT After considering all of the review criteria, summarize the significant strengths and weaknesses of the application and state the likelihood that Neilsen Foundation funding of this project will allow this Postdoctoral Fellow to become an important contributor to the field of SCI research. : .The project is interesting and innovative. The senior mentor is outstanding while the primary mentor can assist with training on issues of wheelchair mobility and research training. The applicant's qualifications are very good. The environment at CIRRIS is excellent for research training.. Concerns with the complexity of the methodology proposed are expressed.The training plan should allow the candidate to get some experience in learning about psychosocial issues related to peer counseling. A course or class on the psychological aspects of counseling, motivation and self-efficacy would provide the candidate with a broader understanding of these issues.

Does the project address an important problem or a critical barrier in the field?
2. If the Aims of the project are achieved, how would this work change or enhance current methods, technologies, treatments, services, or interventions?
3. How will the Fellow's scientific knowledge, technical capability, and/or clinical skills be improved by undertaking this project? : The project address an important issue, that of physical activity (PA) in SCI and proposes to use an innovative approach based on smartphone based peer counseling (SPC). There are 3 main objectives involving development, measurement and feasibility but it is unclear how these may relate to a broader goal of developing and evaluating a tele health program to modify PA behavior. The development of the smartphone approach on itself if achieved can enhance current treatments and contribute to future interventions. However, the lack of methodological clarity and its relation to this broader goal casts doubts about the significance of this study. It is assumed that the fellow will learn to develop an innovative intervention to improve PA. However, this proposal lacks specific information about how the fellow will benefit from conducting this project during her training.

RELEVANCE
The mission of the Craig H. Neilsen Foundation is "to improve the quality of life for those living with spinal cord injury and to support scientific exploration for effective therapies and treatments leading to a cure." The overall goal for the new Psychosocial Research (PSR) initiative is to lead to "better outcomes for people living with SCI." Emphasis is placed on research directed towards: a) increased understanding of psychological, social and environmental determinants of health, functioning and activity participation; b) rehabilitation and habilitation interventions to improve psychological and social functioning, including participation in work, school and other community activities; c) improved measurements of psychological, social and environmental risk factors, protective factors, processes and outcomes; and d) identification of critical service gaps, needed data and/or new areas of exploration, within a psychosocial or socioecological context, as defined by, or with input from, people living with SCI.

:
The proposed project is relevant to the mission of the Craig Nielsen Foundation by proposing an innovative intervention to improve physical activity after SCI. If the project objectives are achieved it will improve our understanding of the determinants of physical activity and will contribute to our current knowledge based by proposing a new intervention to peer counseling. The application lacks specific details about the relevance of this project as part of fellowship training.

Does the FELLOW have the potential to develop as an independent and productive researcher?
3. Are the MENTOR/SPONSOR(S)' RESEARCH QUALIFICATIONS, including research support and track record of mentoring, appropriate for the proposed Fellowship? 4. Is there evidence of a match between the research interests of the Fellow and the mentor/sponsor(s) and is there a demonstrated ability and commitment to assist in assuring the Fellow's success? 5. Do the Research and Training Plans provide the Fellow with the requisite individualized and supervised experiences that will develop his/her research skills and serve as a foundation for a productive career? : 1. The applicant is well suited to the project and to benefit from post-doctoral training. She has a Ph.D in rehabilitation sciences from UBC and a master's degree in Kinesiology. Areas where her knowledge could be improved by this training include those of greater psychosocial relevance including her outcomes of interest: motivation, self-efficacy, and satisfaction with psychological needs, and others as listed. However, these are not discussed in relation to training. 2. The applicant has 13 publications listed of which 6 she is the primary author. This suggests a strong potential to become an independent investigator and productive researcher. 3. The primary mentor, Dr. Routhier is an Assistant Professor and appears to be well qualified from a technical viewpoint. His background, however, is in mechanical engineering, rehabilitation and geriatrics, biomedical engineering and health administration and less so in psychosocial matters. Much of his work has been in wheelchair mobility. The second mentor, Dr. Luc Noreau, is well recognized nationally and internationally and can complement these areas of mentoring based on his background and reputation. 4. There seems to be a good match between the fellow and her proposed mentors' areas of interest and expertise. Both mentors provide supportive letters of recommendation showing their commitment to this fellow's education. 5. There is no detailed information about the mentors' roles in training for this fellowship.

And/or is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
: 1. The approach proposed is not completely novel but it does utilize new technology and a new approach to peer counseling. 2. Using smartphones to encourage behavioral changes has been adopted with other chronic disease populations such as in the fields of diabetes and cardiovascular disease. 3. The project proposes the adaptation of this technology for SCI. APPROACH 1. Is the Research Plan of high scientific quality and does it relate to the applicant's Training Plan? Are the overall strategy, methodology, and analyses wellreasoned and appropriate to accomplish the Specific Aims of the project? 2. Are preliminary data provided to support the feasibility of the project and/or are potential problems, alternative strategies, and benchmarks for success presented? Or, if the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed adequately?
3. If the project involves clinical and/or community-based research: 1) are the plans for protection of human subjects from research risks described and adequate; and 2) are the plans for recruitment of patients/participants appropriate?

:
The overall approach is briefly described and conceptualized into four distinct phases of development, measurement, feasibility leading to a RCT which is not part of this project. The approach uses a mixed method design. The first phase (development) proposes the use of focus groups with professionals and consumers, reviews of literature. The second phase, measurement, uses a Delphi survey method to examine the proposed intervention and achieve 70% consensus. Next it will use a cross sectional design with within subjects comparisons to validate the primary outcome, actigraphy, in this study. 20 participants will be tested using their wheelchairs and examining the ability to propel themselves using both hands. Data analysis procedures are adequate for this phase although the effect of attrition or missing data is not accounted for. The third phase, feasibility, will use a pre-posttest design to assess the feasibility of SPC investigation and other study outcomes. Study outcomes will be collected at 6 months post baseline and 3 month post intervention. The rationale for these time points is unclear plus contamination could occur between selected time points. Is 3 month follow up sufficient to demonstrate some of the selected outcomes such as increased motivation, satisfaction with participation and others. The design of this phase is not clear and lacks details in relation to the overall purpose of the study. The discussion of participants' selection in relation to PA is also unclear. There is no mentioning of neurological classification or presence of comorbidities without much in-depth thinking about the relationship among these outcomes. Furthermore, the proposal seems overtly ambitious. For example, the applicant proposes also to explore various delivery mediums for the SPC intervention. A large number of outcomes are proposed (i.e. anxiety, depression, and social support) but their relation to PA is not clearly described. A Figure depicting the conceptual model of the proposed approach would have been most beneficial in describing the approach. Last, the sample size for phase 3 is too small given the number of variables selected. Effect sizes are discussed without specific calculations based on outcomes. Overall, the proposed approach as described is unclear.
2. There is no preliminary data relevant to the project described. 3. While the plans for recruitment of participants are described, there is no clear mentioning of using informed consents and ways of protecting confidentiality. There is a small section on safety which does not describe specific strategies to be adopted. It appears that the fellow will be placed at CIRRIS, a research center in Quebec City. Based on this information the environment will be conducive to her study and training. The institution seems committed and both mentors submitted letters of support. 1. The budget seems appropriate and there are no concerns. 2. IRB approval is not discussed. 3. The training plan is missing. This is a concern since this is a resubmission and this issue was pointed out during the first submission.

OVERALL IMPACT After considering all of the review criteria, summarize the significant strengths and weaknesses of the application and state the likelihood that Neilsen Foundation funding of this project will allow this Postdoctoral Fellow to become an important contributor to the field of SCI research.
: This is an ambitious application that is justified adequately and proposed by a highly qualified applicant. The smartphone based peer counseling program is moderately novel by proposing to use a peer-coach and smartphone technology to deliver a physical activity intervention. The applicant proposes a scoping review, cross sectional study to validate the primary outcome of interest for measuring physical activity, and evaluate the feasibility of the intervention in the target population. Excellent mentoring resources are available to the applicant.

SIGNIFICANCE 1. Does the project address an important problem or a critical barrier in the field?
2. If the Aims of the project are achieved, how would this work change or enhance current methods, technologies, treatments, services, or interventions?

How will the Fellow's scientific knowledge, technical capability, and/or clinical skills be improved by undertaking this project?
: This project would provide modest enhancement of current methods in physical activity promotion for people with SCI. Completing the project would provide the applicant with enhanced technical capability and skills in conducting technology-enhanced behavioral change research.

The overall goal for the new Psychosocial Research (PSR) initiative is to lead to "better outcomes for people living with SCI." Emphasis is placed on research directed towards: a) increased understanding of psychological, social and environmental determinants of health, functioning and activity participation; b) rehabilitation and habilitation interventions to improve psychological and social functioning, including participation in work, school and other community activities;
c) improved measurements of psychological, social and environmental risk factors, protective factors, processes and outcomes; and d) identification of critical service gaps, needed data and/or new areas of exploration, within a psychosocial or socioecological context, as defined by, or with input from, people living with SCI.

How is this project relevant to the goal of the Psychosocial Research initiative?
: The project is relevant to the mission of the Foundation by seeking to enhance outcomes for people living with SCI. It is relevant to the goal of the Psychosocial Research initiative by seeking to develop rehabilitation interventions to improve the psychological and social functioning of persons with SCI by enhancing their physical and social activity. https://proposalcentral.altum.com/ShowReviewInfo.asp?Pr…D%EF%BF%BD%EF%BF%BD%EF%BF%BD%EF%BF%BD&token2=127578540

Strengths/Forces:
This study is novel in that it studies the use of smartphone-delivered peer physical activity counselling (SPPAC) to increase the physical activity participation of persons using manual wheelchairs based on theories of behaviour from Self-Determination Theory and Social Cognitive Theories. Apparently this particular intervention has not been studied before. Phase 1 of the study will use expert opinion to refine an existing SPPAC program and phase 2 will conduct an RCT to explore the feasibility of conducting a larger RCT & to provide preliminary evidence of the effectiveness of SPPAC. Counselling (SPPAC) intervention to evaluate its feasibility prior to launching a larger trial.

Weaknesses/Faiblesses
The objectives of the proposed research are well defined.
The use of peer counseling, particularly among special populations, and examining the feasibility of using technology to deliver peer counseling warrants exploration.

Rating/Cote: O
Strengths/Forces: Physical inactivity-related chronic disease is a concern among the spinal cord injury population.
There is a demonstrated need for interventions targeting manual wheelchair users (MWC) and although programs have been developed, adherence rates are low. Peer-led interventions have been shown to be effective for increasing self-efficacy but there is limited research focusing on the effect of peers influencing PA among MWC users. Given the high rates of inactivity and increased risk of developing chronic disease, the proposed research has the potential to improve health outcomes among MWC users. Phone-delivered interventions are a preferred method of intervention delivery among the SCI population and thus exporing the use of mobile phone technologies may enhance delivery of interventions by capitalizing on other features of smart phones such as video and text-reminders, in additional to traditional phone calls.

Rating/Cote: E++
Strengths/Forces: The Medical Research Council framework for developing and evaluating complex interventions is being used to guide the research.
The approach involves using the Delphi technique to refine the SPPAC protocol. Components to be presented to experts include delivery methods, intervention duration, frequency of sessions and contact as well as content.
A 3-site RCT will be used to assess the feasibility of the SPPAC. This is a pragmatic trial, which is suitable for the target population. The feasibility indicators are comprehensive.
Investigational outcomes are also comprehensive and include accelerometry to measure PA, LTPA, wheelchair skills, PA interventions. Although understandable about the potential reach and cost effectiveness of using mobile devices as the primary delivery mechanism in this intervention, there are some concerns if there will be the potential to preclude some adults who are not technologically savvy or do have use have a device (e.g. receptivity of technology with age) given in the justification of the study, 8% of older MWC users are not active. Has there been any consideration of a mixed mode of delivery? Peer counselling is an interesting approach, however, would this be feasible on a larger scale?
Criterion/Critère: Importance of the Idea/Importance de l'idée

Strengths/Forces:
The research is an interesting and important topic with the potential impact of positively increasing activity rates among manual wheelchair users. There is a relative lack of research in the area of technology integration with counselling among this population, which this study aims to address. The counselling intervention has the potential to impact behaviour of this population at relatively low cost, and administration seems feasible.
Weaknesses/Faiblesses: Some considerations with approach can be considered in the development of the RCT. RCT specifications are determine to a certain extent on the outcome of the consensus phase of the project.

Rating/Cote: E+
Strengths/Forces: Strengths include theoretically based constructs, use of objective measures, barrier and self efficacy scales associated with wheelchair use and competence. The approach for the RCT seems appropriate although it will be modified based on the consensus phase. Timelines seem appropriate for the study. Challenges that have been identified seem to be addressed in the proposal in an acceptable way, including honoraria to reduce drop outs, and partnerships to aid in recruitment.
Weaknesses/Faiblesses: Are sex, and particularly age, considered for the selection process? Geographical considerations with respect to wheelchair use will need to be considered. Why was a leisure time physical activity measure selected for self-reported frequency as opposed to a overall activity measure which could incorporate transportation and work related activity? It was unclear from the description how the study will be refined based on the results of the first phase of the study. Estimates of the dropout rate seem low, however, estimates are expected to be similar to the telephone methodology used with SCI participants in an earlier study.