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

Glostrup University Hospital, Copenhagen · 2026
ClinicalTrials.gov · Datasets · License: Public Domain · 2026
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caregiversfrailtynaolder-adultssupport
Background Rheumatoid arthritis (RA) is a chronic inflammatory disease associated with pain, fatigue, functional limitations, and reduced quality of life. As more people live to older age with RA, age-related vulnerability such as frailty becomes increasingly relevant and may amplify functional decline, multimorbidity, and reliance on others. Informal caregivers (unpaid family members, friends, or neighbors) often provide substantial practical, emotional, and coordination support, yet caregiver needs are frequently overlooked in rheumatology care. INSPIRE (INtervention to Support Partners and Informal caREgivers of frail RA patients) is an individually tailored support intervention developed using the UK Medical Research Council framework for complex interventions and an iterative co-creation process involving older adults with RA and frailty, caregivers, healthcare professionals, and social care stakeholders. Before a definitive evaluation, feasibility and acceptability in routine care must be established. Aim To evaluate the feasibility and acceptability of delivering INSPIRE in routine rheumatology care and to test study procedures in preparation for a future definitive trial. Methods This is a single-arm feasibility study recruiting 25 informal caregivers of older adults with RA and frailty. Recruitment will occur within a fixed four-month window (1 March-1 July 2026) and will not be extended. Care recipients (older adults) will be ≥65 years with RA and frailty classified as Clinical Frailty Scale (CFS) 4-7. Caregivers will be ≥18 years, provide unpaid support, and report at least moderate burden defined as a Caregiver Burden Scale (CBS) mean score \>1.99 at screening. Participants will be recruited from Rigshospitalet (Center for Rheumatology and Spine Diseases) and rheumatology departments in Køge, Slagelse, and Holbæk. Identification uses routine patient-reported outcomes (DANBIO) with invitation of potentially frail patients (e.g., MDHAQ \>1.0) followed by
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