Intervention to Support Partners and Informal Caregivers of Frail RA-patients
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,
| Condition(s) | Rheumatic Arthritis |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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-creat |
| Who can participate | Inclusion Criteria (Caregivers): * Informal (unpaid) caregiver of an older adult with confirmed rheumatoid arthritis (RA) * Aged ≥ 18 years * Care recipient aged ≥ 65 years * Able to provide informed consent * Able to complete study questionnaires * Reports at least moderate caregiver burden, defined as mean CBS score \> 1.99 at screening (Caregiver Burden Scale) Inclusion Criteria (Care Recipients): * Aged ≥ 65 years * Confirmed diagnosis of RA * Meets frailty eligibility in routine care, defined as Clinical Frailty Scale (CFS) ≥ 5 Exclusion Criteria (Caregivers): * Severe cognitive impairment preventing participation * Acute mental health crisis * Other circumstances making it impracticable to complete the intervention and follow-up assessments |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Glostrup University Hospital, Copenhagen |
| Locations | Glostrup Municipality, Capital Region, Denmark |
| Start date | 2026-03-15 |
| NCT ID | NCT07442773 |
| Official listing | https://clinicaltrials.gov/study/NCT07442773 |