Intervention to Support Partners and Informal Caregivers of Frail RA-patients

This study evaluates the feasibility and acceptability of delivering INSPIRE (INtervention to Support Partners and Informal caREgivers of frail RA patients) within routine rheumatology care and tests study procedures to inform a future definitive trial. INSPIRE is an individually tailored support intervention for informal caregivers of older adults with rheumatoid arthritis (RA) and frailty, developed through stakeholder co-creation and designed for implementation in standard outpatient workflows. Potentially eligible care recipients are identified using routine patient-reported outcomes completed prior to clinic visits (DANBIO). Functional limitation scores (MDHAQ) are used as a pragmatic trigger for further screening. Interested patients are contacted for telephone screening including frailty classification using the Clinical Frailty Scale (CFS). When an eligible patient agrees, they nominate an informal caregiver who is contacted by the study team, provided study information, and screened for caregiver burden using the Caregiver Burden Scale (CBS). Recruitment occurs within a fixed, pre-specified recruitment period. INSPIRE is delivered by trained healthcare professionals with rheumatology context and experience in psychosocial support and service navigation. The intervention is delivered over approximately 12 weeks and consists of three structured contacts: (1) an initial consultation (about 60-90 minutes), (2) a brief follow-up contact (about 15-30 minutes; typically telephone), and (3) a final consultation (about 30-60 minutes). Delivery mode is flexible (clinic, home, or telephone) to reflect real-world implementation. The initial consultation follows a structured needs assessment guided by the caregiver's CBS profile and a semi-structured consultation framework to identify the caregiver's priority burden domains. The healthcare professional supports goal setting and action planning and selects relevant elements from a predefined INSPIRE toolbox. Toolbox elements may include validation of the caregiver role; psychoeducation and coping support; practical strategies to reduce day-to-day strain; communication support within the dyad and with services; RA- and frailty-relevant information; and navigation/signposting to health and municipal services (e.g., home care, assistive devices, respite options, social work pathways). The brief follow-up contact reviews progress, identifies barriers, and adjusts the action plan and toolbox elements as needed. The final consultation consolidates strategies used, reviews ongoing support needs, and supports planning for continued access to relevant services. The older adult with RA may optionally participate in selected consultations when preferred by both parties; the caregiver remains the primary intervention recipient. Feasibility is assessed using descriptive metrics including screening and recruitment flow, retention through follow-up, completeness of questionnaire data, and intervention deliverability (sessions completed, timing, duration, and mode). Acceptability is assessed post-intervention using the Acceptability of Intervention Measure and supplemented by brief structured questions and qualitative interviews with caregivers (and optionally older adults and/or delivering professionals) to explore perceived usefulness and implementation barriers and facilitators. Intervention fidelity and tailoring are documented using structured session notes recording components delivered, toolbox elements selected, caregiver goals, and referrals/signposting. Analyses are descriptive and focus on feasibility and process outcomes. Candidate outcome measures are summarized at baseline and follow-up to assess completeness and variability; exploratory pre-post changes may be presented without formal hypothesis testing. The intervention is considered low risk; discussions may elicit emotional discomfort, and participants may pause or discontinue at any time. Delivering professionals follow predefined signposting/referral pathways if significant distress is identified. Data are managed securely and reported in anonymized form in accordance with applicable data protection requirements.