Study registration
The protocol of this systematic review has been registered on PROSPERO 2013 (registration number: CRD42013006748) [27]. The systematic review protocol has been conducted and reported using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement guidelines [28].
Search strategy for identification of relevant studies
We will conduct a comprehensive search for articles indexed on MEDLINE, EMBASE, CINAHL, PsycINFO, AMED, Cochrane Central Register of Controlled Trials (CENTRAL), PEDro and Science Citation Index Expanded (SCI-EXPANDED) databases from their inception to December 2013. A search strategy has been designed with the assistance of an experienced research librarian. We have developed a search strategy in MEDLINE (Appendix 1) which has been customised to account for differences in indexing across other databases. We will screen the reference lists of relevant reviews on this topic to identify further studies for potential inclusion in this review. Non-English language studies will be included, where a translation can be made available.
Eligibility criteria
Types of study
We will include only those studies that are randomised controlled trials, or quasi-randomised controlled trials. A quasi-randomised controlled trial is defined as a trial in which the participant’s allocation is not truly random, such an allocation by date of birth.
Participants
We will include studies of adults (aged 18 years or older) living in the community who have a non-degenerative ABI. ABI refers to any damage to the brain that occurred after birth, such as from trauma or a stroke. We will exclude any studies that examine ABI that is degenerative in nature, such as studies of Parkinson’s disease, or studies of people undergoing significant medical or surgical intervention, such as chemotherapy. However, participants who have sustained an ABI as a result of an adverse outcome from a surgery will be included. We will also exclude papers where this status is unclear, such as various types of brain cancer. We will also exclude any studies of people residing in nursing homes or other non-independent care facilities, or who are inpatients in a hospital or other healthcare facility. There will be no restriction of duration since injury.
In studies where it is unclear that participants meet our inclusion criteria we will contact the study author for verification. We will exclude any studies where verification cannot be made by the author in regards to our inclusion criteria. Studies in which there is a mixed sample (with respect to residential status, age or health condition) will only be included if at least 75% of the participants meet our inclusion criteria.
Intervention
We will include studies that have assessed the efficacy of a self-management intervention which aims to enhance levels of physical activity or other outcomes specifically associated with physical activity. Physical activity refers to any bodily movement produced by skeletal muscles that requires energy expenditure [29]. Other outcomes associated with physical activity include physical activity related self-efficacy, physical self-concept, social support or decisional balance for physical activity, and stages of change in regards to physical activity.
Interventions can be provided by health professionals, lay people or a combination of both. Interventions can be delivered in a group setting or on an individual basis. The self-management intervention may be generic or specific to a health condition; however it must include at least one of the following components: problem-solving, goal-setting, decision-making, self-monitoring, coping strategies or another approach to facilitate behaviour change. Studies including advice and education only will be excluded.
The self-management programme can be administered in a variety of settings, such as a private home, a hospital or a community centre. However, participants must be community-dwelling.
For review question 1, the intervention may be delivered via a variety of delivery formats, such as face-to-face, text messages, telephone, Internet or postal delivery. For review question 2, the intervention will include only those studies that have self-management programmes delivered remotely, such as via the Internet, text messages, telephone or by postal delivery. Any studies that have directly compared two types of self-management approaches will be included for content analysis.
Comparator or control
For review question 1, we will include studies that compare a self-management intervention with any of the following: usual care, waiting list control, no treatment, written information only, education and advice only, or an alternative treatment that is not considered to be self-management. For review question 2, comparative studies will be those papers that met all the inclusion criteria for review question 1, and delivered the self-management programme via face-to-face delivery. As stated above, any studies that have directly compared two types of self-management approaches will be included for content analysis.
Outcome measures
Primary outcomes
We will include studies that have examined at least one of the following primary outcome measures:
● A measure of physical activity, either from a physical activity monitoring device (for example, accelerometer, pedometer), or from a self-report measure of physical activity; and/or;
● A primary study outcome associated specifically with physical activity; such as physical activity self-efficacy or physical self-concept.
We will extract data for primary outcomes assessed at baseline and all follow-up time points.
Secondary outcomes
For studies that meet inclusion criteria the following secondary outcomes will also be examined:
● Self-efficacy (general) - usually measured by a self-efficacy scale, such as the General Self-Efficacy Scale [30] or the Stroke Self-Efficacy Scale [31];
● Participation measures - such as the Modified Reintegration to Normal Living Index (mRNL) [32], Life Habits questionnaire (LIFE-H) [33] or the Community Integration Questionnaire (CIQ) [34];
● Activity measures - such as the Step test, 10 m walk test , 6 min walk test, Timed Up and Go test;
● Impairments - such as depression (for example, PHQ-9 [35]), anxiety (for example, GAD-7 [36]), strength, cardiovascular fitness;
● Quality of life measures - such as the WHO Disability Assessment Schedule (WHODAS-II) [37], or the WHO Quality of Life assessment instrument (WHOQoL) [38];
● Participant satisfaction - either quantitative or qualitative;
● Cost-effectiveness.
We will extract data for secondary outcomes assessed at baseline and all follow-up time points.
We will also record any adverse outcomes that are reported in studies included in this review.
Screening of studies
Studies will be selected for this review by two authors who will independently assess the titles and abstracts of all records identified from the searches of the electronic databases by excluding studies that do not meet all inclusion criteria. The full text of the remaining studies will be obtained and independently reviewed by two authors for eligibility according to the criteria using a standardised eligibility criteria sheet. If needed, further information will be obtained from the authors where possible. Disagreements will be resolved by discussion and consensus. If required, arbitration will occur by a third review author blinded to previous eligibility ratings.
Data extraction
Data from the remaining included studies will be extracted independently by two reviewers using a standardized data extraction form. This form will include collection of the following data: source, year of publication, country of origin, study design, sample size (including participants that have been lost to follow-up), characteristics of the study population (age, gender and cause of ABI), characteristics of the intervention (delivery mode and method, duration, description of content), characteristics of control/comparison (delivery mode, duration, description of content), type of outcome measures used - primary and secondary, outcome measures for identified time points as above and statistical analysis.
Risk of bias (quality) assessment
Two reviewers will independently assess the risk of bias for each included study using The Cochrane Collaboration’s tool for assessing bias[39]. The criteria included in this tool are: random sequence generation, concealed allocation, blinding, completeness of data collection and selective outcome reporting. We will summarise bias as being ‘low’, ‘high’ or ‘unclear’ for each criterion. A summary of risk of bias across all studies within each domain will also be provided.
Strategy for data synthesis
For review questions 1 and 2, Review Manager software, RevMan[40], will be used to conduct a meta-analysis where possible to calculate an overall effect size for physical activity. Where data are too heterogeneous to perform a meta-analysis, the results from individual studies will be summarised in a table and a narrative synthesis will be conducted. If, during this synthesis, homogeneity is established within a subgroup, a meta-analysis of data for this subgroup will be performed. A risk of bias assessment of included studies will be summarised in a table and results and implications will be critically discussed.
In order to examine the features associated with greater efficacy and participant satisfaction, a content analysis will be conducted to compare aspects of the intervention that are associated with more favourable study outcomes.
Analysis of subgroups or subsets
In order to address review question 2, a subgroup analysis of different mechanisms of intervention delivery will be conducted, where appropriate, to enable a comparison of remote delivery methods with traditional face to face methods of delivery.
If appropriate a subgroup analysis may be conducted to compare efficacy of self-management programmes to enhance physical activity in young adults (aged 18–50 years) versus older adults (aged over 50 years), and in stroke versus traumatic brain injury.