Randomised Pragmatic Waitlist Trial with Process Evaluation Investigating the Effectiveness of Peer Support After Brain Injury: Protocol

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aut.relation.articlenumbere069167
aut.relation.issue2
aut.relation.journalBMJ Open
aut.relation.startpagee069167
aut.relation.volume13
dc.contributor.authorKayes, Nicola
dc.contributor.authorCummins, Christine
dc.contributor.authorWeatherall, Mark
dc.contributor.authorSmith, Greta
dc.contributor.authorTe Ao, Braden
dc.contributor.authorElder, Hinemoa
dc.contributor.authorFadyl, Joanna Kirstin
dc.contributor.authorHoward-Brown, Christine
dc.contributor.authorFoster, Allison
dc.contributor.authorKersten, Paula
dc.date.accessioned2023-02-20T21:08:39Z
dc.date.available2023-02-20T21:08:39Z
dc.date.copyright2023-02-07
dc.date.issued2023-02-07
dc.description.abstractINTRODUCTION: Traumatic brain injury (TBI) is an important global health problem. Formal service provision fails to address the ongoing needs of people with TBI and their family in the context of a social and relational process of learning to live with and adapt to life after TBI. Our feasibility study reported peer support after TBI is acceptable to both mentors and mentees with reported benefits indicating a high potential for effectiveness and likelihood of improving outcomes for both mentees and their mentors. OBJECTIVES: To (a) test the effectiveness of a peer support intervention for improving participation, health and well-being outcomes after TBI and (b) determine key process variables relating to intervention, context and implementation to underpin an evidence-based framework for ongoing service provision. METHODS AND ANALYSIS: A randomised pragmatic waitlist trial with process evaluation. Mentee participants (n=46) will be included if they have moderate or severe TBI and are no more than 18 months post-injury. Mentor participants (n=18) will be people with TBI up to 6 years after injury, who were discharged from inpatient rehabilitation at least 1 year prior. The primary outcome will be mentee participation, measured using the Impact on Participation and Autonomy questionnaire after 22 weeks. Primary analysis of the continuous variables will be analysis of covariance with baseline measurement as a covariate and randomised treatment as the main explanatory predictor variable at 22 weeks. Process evaluation will include analysis of intervention-related data and qualitative data collected from mentors and service coordinators. Data synthesis will inform the development of a service framework for future implementation. ETHICS AND DISSEMINATION: Ethics approval has been obtained from the New Zealand Health and Disability Ethics Committee (19/NTB/82) and Auckland University of Technology Ethics Committee (19/345). Dissemination of findings will be via traditional academic routes including publication in internationally recognised peer-reviewed journals. TRIAL REGISTRATION NUMBER: ACTRN12619001002178.
dc.identifier.citationBMJ Open, ISSN: 2044-6055 (Print); 2044-6055 (Online), BMJ, 13(2), e069167-. doi: 10.1136/bmjopen-2022-069167
dc.identifier.doi10.1136/bmjopen-2022-069167
dc.identifier.issn2044-6055
dc.identifier.issn2044-6055
dc.identifier.urihttps://hdl.handle.net/10292/15880
dc.languageeng
dc.publisherBMJ
dc.relation.urihttp://dx.doi.org/10.1136/bmjopen-2022-069167
dc.rights.accessrightsOpenAccess
dc.subjectClinical trials
dc.subjectNeurological injury
dc.subjectREHABILITATION MEDICINE
dc.subjectClinical trials
dc.subjectNeurological injury
dc.subjectREHABILITATION MEDICINE
dc.subjectRehabilitation
dc.subjectInjury - Traumatic brain injury
dc.subjectInjury (total) Accidents/Adverse Effects
dc.subjectBrain Disorders
dc.subjectClinical Trials and Supportive Activities
dc.subjectInjury - Trauma - (Head and Spine)
dc.subjectComparative Effectiveness Research
dc.subjectHealth Services
dc.subjectBehavioral and Social Science
dc.subjectClinical Research
dc.subjectMental health
dc.subject3 Good Health and Well Being
dc.subject1103 Clinical Sciences
dc.subject1117 Public Health and Health Services
dc.subject1199 Other Medical and Health Sciences
dc.subject.meshBrain Injuries
dc.subject.meshBrain Injuries, Traumatic
dc.subject.meshCounseling
dc.subject.meshDisabled Persons
dc.subject.meshHumans
dc.subject.meshMentors
dc.subject.meshPragmatic Clinical Trials as Topic
dc.subject.meshQuality of Life
dc.subject.meshRandomized Controlled Trials as Topic
dc.subject.meshHumans
dc.subject.meshBrain Injuries
dc.subject.meshBrain Injuries, Traumatic
dc.subject.meshCounseling
dc.subject.meshDisabled Persons
dc.subject.meshMentors
dc.subject.meshQuality of Life
dc.subject.meshRandomized Controlled Trials as Topic
dc.subject.meshPragmatic Clinical Trials as Topic
dc.subject.meshHumans
dc.subject.meshBrain Injuries
dc.subject.meshCounseling
dc.subject.meshQuality of Life
dc.subject.meshMentors
dc.subject.meshDisabled Persons
dc.subject.meshRandomized Controlled Trials as Topic
dc.subject.meshPragmatic Clinical Trials as Topic
dc.subject.meshBrain Injuries, Traumatic
dc.subject.meshHumans
dc.subject.meshBrain Injuries
dc.subject.meshBrain Injuries, Traumatic
dc.subject.meshCounseling
dc.subject.meshDisabled Persons
dc.subject.meshMentors
dc.subject.meshQuality of Life
dc.subject.meshRandomized Controlled Trials as Topic
dc.subject.meshPragmatic Clinical Trials as Topic
dc.titleRandomised Pragmatic Waitlist Trial with Process Evaluation Investigating the Effectiveness of Peer Support After Brain Injury: Protocol
dc.typeJournal Article
pubs.elements-id492543
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