Co-developing a novel intervention to promote wellbeing of family caregivers of individuals with a spinal cord injury: Research protocol

Abstract

Family caregivers of individuals with spinal cord injury (fcSCI) are responsible for providing assistance with activities of daily living for individuals with spinal cord injury (SCI), which can include emotional support and physical assistance. Over time, providing daily support can put fcSCI at risk of experiencing caregiver burden. Burden and distress can have a substantial impact on fcSCI’s wellbeing as well as their ability to respond to the needs of the individual with SCI. A direct predictor of fcSCI burden is their appraisal of their ability to cope with the individual with SCI’s illness. Therefore, supporting fcSCI’s access to education relevant to their role and the health and wellbeing of the individual with SCI can help decrease levels of burden. The purpose of this study is to evaluate the fidelity of the intervention named COMPANION and the study protocol for an eHealth approach designed to improve outcomes for fcSCI. COMPANION, co-created with caregiver partners, is an online education program designed to provide accessible education and support for fcSCI. A concurrent mixed methods study including a feasibility randomized controlled trial will be conducted to (i) assess the process, resource, management and treatment indicators; (ii) estimate the parameters needed for a full-scale, multi-site randomized controlled trial and (iii) evaluate the effect that COMPANION has on caregiver clinical outcomes compared to a control group. The primary outcome measured will be fcSCI’s burden in addition to secondary outcomes measuring depression, anxiety, relationship satisfaction, and quality of life. The fcSCI in the intervention group will be given access to COMPANION (at T1) and data will be collected again after three months (T2) and six months (T3) to capture the impact of COMPANION on fcSCI’s psychological wellbeing. Study results will evaluate whether the full study can and should be conducted and will lead to refinement of COMPANION.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

The trial is registered on ClinicalTrials.gov. The ClinicalTrials.gov ID is NCT06364813 and the Protocol ID is H20-01461. The trial URL ishttps://clinicaltrials.gov/study/NCT06364813

Funding Statement

Yes

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Not Applicable

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

This research has been approved by the University of British Columbia Behavioural Research Ethics Board with ID# H20-01461. Written consent was obtained.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Not Applicable

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Not Applicable

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Not Applicable

Data Availability

No datasets were generated or analysed during the current study. All relevant data from this study will be made available upon study completion.

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