Collaborative Care and Everyday Planning in Care Counselling (CoPlan study): study protocol of a pragmatic randomized clinical trial and protocol changes to quasi-experimental evaluation during recruitment

Abstract Background Family members are the primary source of support for older care recipients. Promoting cooperative strategies between family members may foster shared solutions to care-related challenges. Based on our previous research we developed a dyadic problem-solving intervention that equally addresses the needs of both caregivers and care recipients. Methods This pragmatic randomized controlled clinical trial evaluates the implementation and effectiveness of the intervention under routine conditions within a national care counselling service setting. Due to recruitment obstacles and low participant enrolment the randomized design was modified to a non-randomized study. Main inclusion criterion for caregivers was a positive screening of desire to change the care situation, frequent caregiving challenges, or difficulty managing care. Participants are assigned to either the CoPlan intervention or control group with routine care counselling. Self-reported questionnaires are administered at baseline ( t 0 ) and 3 months post-intervention ( t 2 ) to collect endpoint data, with an intermediate non-endpoint assessment following the initial counselling ( t 1 ). Primary and secondary endpoint comparisons are based on data collected at t 2 controlled for baseline values. Primary outcome is the quality of informal care (QiC), main secondary outcomes include caregiver self-efficacy, depressive symptoms, and positive aspects of caregiving. A process evaluation assesses intervention dose, fidelity, and experiences of interventionists, care counsellors of a German long-term care insurance, and participants. Discussion This study represents one of the few translational studies in care counselling research. By promoting shared appraisals and open communication in a dyadic approach, the novel counselling method addresses a largely underexplored area. The difficulty in recruiting participants through care counsellors, along with the resulting study design modification, highlights the difficulties of conducting studies within real-world practice settings. Trial registration Deutsches Register Klinischer Studien (German Clinical Trials Register), DRKS00032492 . Registered on 5 September 2023 (current status: recruitment completed).