Accepted for/Published in: JMIR Research Protocols
Date Submitted: May 21, 2021
Date Accepted: Apr 21, 2022
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
The Impact of an Evidence-Informed Spinal Cord Injury Activities of Daily Living Educational Manual (SADL-eM): study protocol for a randomized clinical trial
ABSTRACT
Background:
This study argues that providing evidence-based occupational therapy patient education is vital in order to optimize rehabilitation outcomes.
Objective:
The planned trial aims to evaluate the SADL-eM intervention for people with SCI compared with standard treatment.
Methods:
This is a parallel randomized clinical trial with two study arms, intervention and control. Ninety patients treated in inpatient rehabilitation settings will be randomly allocated to two study groups. Both groups will receive standard care. The intervention group will also receive a copy of the SADL-eM from their treating occupational therapist during an individual session. Assessment on admission (baseline measure) and after six weeks of admission will use the SCIM-SR as the primary outcome measure. Secondary outcomes include the SCIM-III, Private Religiousness Practices Scale, Organizational Religiousness Short-Form, additional domains of ADL covered by the educational manual and adherence to intervention. Effect will be determined using repeated measures ANOVA.
Results:
This study will be conducted from April 2021 through March 2022, with results expected to be available in May 2022.
Conclusions:
The SADL-eM is a comprehensive ADL educational tool that aims to optimize rehabilitation outcomes for people with SCI. If the SADL-eM is demonstrated as clinically effective, this will have significant implications for occupational therapy interventions in Low and Middle Income Countries settings. Clinical Trial: Trial registration: Stellenbosch University HREC Project ID: 1635, Helsinki Committee for Ethical Approval (PHRC/HC/689/20) International Registered Report Identier (IRRID): NCT04735887 Date of registration: 30/11/2017, Renewed 12/06/2020
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