A commentary on methodological issues in stroke caregiver research: lessons learned from three RESCUE intervention studies

Stroke caregivers represent a distinct population and require unique considerations when conducting intervention research. Unfortunately, there are few published recommendations for conducting intervention trials with stroke caregivers. Thus, the goal of this paper is to provide foundational guidance for stroke caregiving researchers. We describe lessons learned from three trials of the RESCUE intervention to illustrate methodological issues in stroke caregiver research. We identify challenges encountered while conducting a clinical demonstration project, pilot study, and multi-site randomized controlled trial of a problem-solving and skills-building stroke caregiver intervention. We use our research experiences to exemplify or enhance understanding of each issue and describe the strategies we employed to overcome these obstacles. We present issues related to and recommendations for study design, theoretical frameworks, eligibility criteria, recruitment and retention, human subjects protection, intervention design, treatment fidelity, outcome measures, and qualitative methods. Identifying approaches to circumvent methodological challenges can help advance research on and implementation of stroke caregiver programs.