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People with recently acquired spinal cord injury (SCI) experience changes in physical, social and psychological aspects of their lives. In the last decades, attention has grown for aspects of self-management and self-efficacy in SCI research. However, we still do not know what the self-management and self-efficacy outcomes of first rehabilitation are and whether utilizing these skills may prevent secondary health conditions (SHCs) and increase participation and psychological adjustment early after SCI.
To describe the course and determinants of self-management and self-efficacy during and after first SCI rehabilitation; and to determine theory-based associations between self-management and self-efficacy with SHCs, participation and psychological adjustment.
Multicenter prospective longitudinal cohort study. All people with a newly acquired SCI admitted to one of the 8 specialized SCI rehabilitation centers in the Netherlands will be considered for inclusion in this study. Main assessments will take place during the first and last week of admission and 3, 6 and 12 months after discharge. The target sample is 250 participants. The primary outcomes are self-management (knowledge and execution of self-care) and self-efficacy (confidence in the ability to manage the consequences of SCI and of self-care). Secondary outcome measures are SHCs, participation and psychological adjustment to SCI.
The first results with the complete set of data are expected in June 2019.
This protocol describes the SELF-SCI cohort study investigating self-management and self-efficacy of initial inpatient SCI rehabilitation. Second, associations will be investigated with SHCs, participation and psychological adjustment early after onset of SCI, until 1 year after discharge. The results will be used to test theories about motivation to perform health-promoting behaviors and adjustment to SCI.
The global incidence of spinal cord injury (SCI) is estimated between 40 and 80 new cases per million population per annum [
SHCs are common in people with SCI in the Netherlands [
The high prevalence and the chronic nature of SHCs, can lead to the conclusion that SCI should be seen as a chronic condition, rather than an incidental trauma. This also focuses attention to the crucial role and responsibility persons with SCI themselves have regarding the lifelong maintenance of their health and participation in the society. During first rehabilitation of people with SCI, learning and practicing self-management skills should therefore be a main concern.
Self-management is defined as the individual’s ability to manage the symptoms, treatment, physical and social consequences and lifestyle changes in accordance to a life with a chronic disease (Chronic Care Model) [
Another concept associated with high prevalence of SHCs, especially psychological SHCs, is self-efficacy [
The SELF-SCI study has been designed to investigate this gap. The aims of the SELF-SCI study are: 1) to describe the course of self-management and self-efficacy during and after the first year of clinical SCI-rehabilitation; 2) to examine determinants of self-management based on the theory of planned behavior (TPB); 3) to examine determinants of adjustment after SCI based on the SCI adjustment model (SCIAM).
To understand how people handle the consequences of their SCI, it is not only important to know the aspects involved in health-related behavior, but also the way people adjust to this situation. Therefore we will use two complementary models; the Theory of Planned Behavior (TPB) which has its focus on health-promoting behavior [
According to TPB, the intention of people to perform health-promoting behaviors depends on their attitude, subjective norms and perceived behavior control. The scheme of TPB is depicted in
The SCIAM (
The continuous process of appraisal and re-appraisal of the situation has a central role within SCIAM. First there is the perception of the current situation, the primary appraisal, then there is the secondary appraisal to what extent the person has sufficient resources to deal with this situation. These beliefs are influenced by the aforementioned physical, social and psychological factors. A variety of psychological resources have been associated with adjustment in the literature [
In studies on self-efficacy during and shortly after SCI rehabilitation, moderate relationships between self-efficacy with participation and psychological wellbeing were found [
To investigate the role of both self-management and self-efficacy, TPB and SCIAM were used to design the current study. All the aspects described in both theoretical models were taken into account by measuring each aspect through one or more assessment tools.
Scheme of theory of planned behavior.
Scheme of spinal cord injury adjustment model.
SELF-SCI is a multicenter prospective longitudinal cohort study during the first SCI inpatient rehabilitation until one year after discharge. To describe the course of self-management and self-efficacy, repeated measures of the main outcome variables are used. In this quantitative study all aspects described in the theoretical models (TPB and SCIAM) are investigated, to examine determinants of self-management and adjustment after SCI.
The main outcome variables of the first aim of this study are self-management and self-efficacy. Self-management is operationalized as knowledge and execution of self-care. Selfefficacy is measured at two levels; the level SCSE and of DMSE.
The main outcome variable of the second aim is self-management. Main determinants of self-management are SCSE, attitudes towards self-management and subjective norm.
The main outcome variable of the third aim is adjustment. Adjustment is operationalized as distress, illness cognitions, life satisfaction and participation. Demographic, physical -, social aspects and psychological resources are taken into account as determinants of adjustment.
The
The
To measure the
The
The way participants are
An overview of all measurement instruments is shown in
The Medical Ethics Committee of the University Medical Centre Utrecht declared that this protocol does not need formal ethical approval under the Dutch law regulating medical research in human beings (reference number: 15-449/C). The Medical Ethics Committees of all participating rehabilitation centers approved this protocol. The study will be carried out according to the code of conducts formulated by Helsinki code. As part of this code all participants will give written informed consent before entering the study.
Measurement instruments on the different test occasions.
Outcome measures | Instrument | T1 | T2-T4 | T5 | T6 | T7 | T8 | |
Self-management (first and second aim) | Knowledge and execution of self-care | X | X | |||||
Self-care Self-efficacy (first aim) | Self-efficacy for Managing Chronic Disease Scale, Managing disease in General subscale | X | X | |||||
Disability management Self-efficacy (first aim) | University of Washington Self-Efficacy Scale-Short Form | X | X | X | X | X | ||
Distress (third aim) | Hospital Anxiety and Depression Scale | X | X | X | ||||
Illness cognitions | Illness Cognitions Questionnaire | X | X | X | ||||
Life satisfaction (third aim) | Two Life Satisfaction questions | X | X | X | X | X | X | |
Participation (third aim) | Utrecht Scale for Evaluation of Rehabilitation, participation part | X | X | |||||
Participation (third aim) | Craig Handicap Assessment and Reporting Technique, 2 questions | X | X | X | ||||
Stimulation from environment | Stimulation to Perform Self-Care List | X | X | |||||
Motivation to prevent health problems | Motivation for Health Care List | X | X | X | X | |||
SCI characteristics | — | X | X | |||||
Functional independence | Utrecht Scale for Evaluation of Rehabilitation | X | X | |||||
Experienced pain, fatigue and mood | Numeric Rating Scale | X | X | X | X | X | X | |
Medical consumption | Questions about received help | X | X | X | X | |||
Experienced complications | Spinal Cord Injury Secondary Conditions Scale | X | X | X | X | |||
Appraisal | Appraisal Life Events Scale | X | X | X | ||||
General self-efficacy | General Competence Scale (ALCOS-12) | X | ||||||
Resilience | Brief Connor-Davidson Resilience Scale | X | ||||||
Personality | Eysenck Personality Questionnaire, neuroticism subscale | X | ||||||
Meaning in life | Purpose in Life Scale (short version) | X | ||||||
Passive coping | Utrecht Coping List, passive reaction patron subscale | X | ||||||
Active coping | Utrecht Pro-active Coping Competence Scale (short version) | X | ||||||
Social support | Social Support List-12 | X | ||||||
Demographic determinants | Age, sex, level of education, marital status, and other | X |
In the Netherlands 8 rehabilitation centers are specialized in SCI rehabilitation. All 8 centers participate in this study. In this protocol patients are eligible for this study if they have been admitted for inpatient rehabilitation with a clinically confirmed diagnosis of SCI, this is their first inpatient rehabilitation after the onset of the SCI, and this admission will last for at least 4 weeks. Furthermore the patient must be at least 18 years old and be able (with help if necessary due to hand function problems) to complete the self-report questionnaires. Patients with severe cognitive problems are excluded, as well as patients who have insufficient knowledge of the Dutch language to understand and complete the questionnaires. Patients are also excluded from this study if they have a limited life expectancy, for example in case of cancer-related SCI. There are no restrictions regarding the severity of SCI or maximum age. Decision on in/exclusion is based on the clinical judgment by the rehabilitation physician and will be checked by the research assistant. If the participants are not able to complete the questionnaire because of hand function problems, help is offered by a research assistant.
All eligible patients will be informed about the study by their rehabilitation physician on the first day of admission into rehabilitation. One or two days later the research assistant will inform the patient more extensively. After informed consent is given, the research assistant will provide the participant with the first comprehensive questionnaire (T1). Next, a short 5-item questionnaire will be administered after 4 (T2), 8 (T3) and 12 weeks (T4), if at that time the participant is still admitted for at least two weeks. In the last week of admission the second comprehensive questionnaire (T5) will be administered. Three (T6) and six months (T7) after discharge a brief questionnaire will be sent to the participants, and one year after discharge the final comprehensive questionnaire (T8) will follow. During inpatient rehabilitation, participants will complete paper/pencil versions of the questionnaires. After discharge, the participants can choose whether they want to complete the questionnaire on paper or online (NetQ package). Before the questionnaire is sent after discharge (T6 to T8), the participants will be contacted by phone, further two reminders will be send in case of no response. Participants will not be offered monetary or non-monetary compensation for their efforts.
A total of 250 participants will be recruited. This target number is chosen to allow regression models with 15 determinants with sufficient statistical power per determinant in the model. An estimated 350-400 people who fit the in- and exclusion criteria are admitted to one of these 8 specialized centers each year. Therefore, it seems feasible to include the desired 250 participants within the two-year inclusion period from January 2016 until December 2017.
All data will be entered into SPSS statistical program for Windows (version 24). The manually entered data will be checked by a second person. The data from the online questionnaires will be exported and merged with the manually entered data. When all data is entered descriptive statistics will be performed. Outliers and scores out of range of the questionnaires will be double-checked. Next, multilevel analysis, with mixed methods approach, will be performed to estimate differences between the three major assessments (T1, T5 and T8) and between all 8 assessments with a limited number of variables. Next, latent class growth mixture modeling will be used to investigate if there are different trajectories of self-management and DMSE between admission and one year after discharge. Prediction of problems regarding self-management and DMSE on T8 will be analyzed using multivariate regression models. Also relationships between self-management, DMSE and SCSE on the one hand and SHCs, participation and psychological adjustment on the other will be analyzed using multivariate regression analyses and path analysis.
The first aim of this study is to describe the course of self-management and self-efficacy during the first SCI rehabilitation period until one year after discharge. All available data concerning the three main variables will be used. For the second and third aim (examine the determinants of self-management and adjustment) the theory will be tested using a path analysis.
The SELF-SCI Cohort study investigates the changes in self-management and self-efficacy of people with a recently acquired SCI during the first initial rehabilitation until one year after discharge. Next, this study determines, based on theories about motivation to perform health-promoting behaviors and adjustment to SCI, to what extent self-management, DMSE and SCSE are predictors of SHCs, participation and psychological adjustment.
There are several reasons why this cohort study is innovative. First its focus on the changes in self-management, self-efficacy over time, from shortly after the occurrence of SCI until one year after inpatient rehabilitation. Traditionally, much research and rehabilitation care has focused on the physical and functional impact of SCI. Research on psychological impact of SCI is most often cross sectional and performed in community-dwelling people with SCI. In addition, this longitudinal study focuses on the post-acute phase until one year after SCI-rehabilitation. Second, this study will investigate the relationship between self-management and self-efficacy on the one hand and SHCs, participation and psychological adjustment on the other. With a growing amount of older people with SCI, these SHCs and reduced participation in society is of major interest for health workers and policy makers. Thirdly, this study is theory driven. The present study will extensively investigates the influence of motivation to perform health-promoting behaviors and adjustment to SCI on self-management and self-efficacy. All the variables within both theories will be taken into account, as much as possible, in order to be able to test these models for the SCI population [
A limitation of this study could be the fact that the outcomes are only measured with self-assessment questionnaires. However, we do not consider this as a problem, because especially DMSE and SCSE are subjective concepts which we will measure with a validated scale.
In conclusion, the information which will be gathered in the present study, especially about the influence of self-management and DMSE on SHCs and participation, will be used to establish better rehabilitation care and to develop new interventions for SCI patients. This should allow people with SCI to make optimal use of their capacity to deal with their new situation.
disability management self-efficacy
general self-efficacy
numeric rating scale
quality of life
secondary health condition
spinal cord injury
spinal cord injury adjustment model
self-care self-efficacy
theory of planned behavior
The SELF-SCI study is funded by the Dutch Rehabilitation foundation (Revalidatiefonds), grant number 2014039. The funder had no role in designing the study, nor will it have on data collection or during the analysis of the data.
The SELF-SCI group consists of: Rehabilitation center Adelante: Anke Verlouw and Hanneke Bouwsema; Rehabilitation center De Hoogstraat: Catja Dijkstra, Eline Scholten and Chantal Hillebrecht; Rehabilitation center Heliomare: Willemijn Faber, Joke Boerrigter and Carla van Benschop; Rehabilitation center Reade: Christof Smit and Floor van Lambalgen; Rijndam Rehabilitation: Dorien Spijkerman, Karin Postma and Esther Groenewegen; Rehabilitation center Het Roessingh: Govert Snoek and Iris Martens; Rehabilitation center Sint Maartenskliniek: Ilse van Nes and Tijn van Diemen; Rehabilitation center UMCG: Ellen Roels and Joke Sprik.
MP developed the idea and procured funding for the study. TvD and ES worked out the details of the study. All authors contributed to the design and the protocol of the study. All authors reviewed the manuscript and approved the final version.
None declared.