Feasibility and exploratory outcomes of the COMPANION eHealth tool for the wellbeing of family caregivers of individuals with spinal cord injury.

STUDY

DESIGN

Feasibility randomized controlled trial (ClinicalTrials.gov identifier: NCT06364813).

OBJECTIVES

To evaluate the feasibility of the COMPANION eHealth tool, designed to support the well-being of family caregivers of individuals with spinal cord injury (SCI).

METHODS

Fifty-one participants were randomized to either the COMPANION group or the control group. Participants completed a series of measures at baseline and at three and six months after baseline. Feasibility outcomes assessed process, resources, management, and treatment. The clinical outcomes reported here included caregiver burden, distress, relationship satisfaction, and caregiver competence.

RESULTS

Eight of 12 feasibility indicators satisfied predefined benchmarks. Specifically, the study protocol achieved feasibility targets for 'recruitment', 'consent', 'retention', 'assessor masking', 'Data collection: Participant & Evaluator burden', 'participant and expert burden', 'participant processing time', and 'treatment administration'. Three indicators ('treatment adherence', 'Platform and Internet stability', and 'dose-level response') fell short of their respective benchmarks mainly due to measurement or technical limitations, while a fourth ('perceived usability') fell below because participants reported lower anticipated future use. There were no statistically significant differences between the two groups.

CONCLUSIONS

Our findings provide some support for the feasibility of the study protocol for evaluating COMPANION. However, 'treatment adherence', 'Platform and Internet stability', and 'dose-level response' require attention. The findings regarding anticipated future use suggest the need to employ strong engagement strategies, such as a peer support component and reminders, to keep participants engaged with COMPANION. Moreover, it is possible that COMPANION was more beneficial for newer caregivers than for more experienced caregivers.