Support program for partners and informal caregivers of frail older adults with rheumatoid arthritis
Protocol for the Feasibility Study of INSPIRE: an Individually Tailored Support Intervention for Informal Caregivers of Older Adults With Rheumatoid Arthritis and Frailty
This project tests a tailored, 12-week support program for unpaid caregivers of older adults (65+) with rheumatoid arthritis and frailty to reduce caregiver burden and help navigate care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Glostrup University Hospital, Copenhagen Academic / other |
| Locations | 1 site (Glostrup Municipality, Capital Region) |
| Trial ID | NCT07442773 on ClinicalTrials.gov |
What this trial studies
INSPIRE is a co-created, individually tailored support intervention delivered within routine rheumatology outpatient workflows and developed with input from patients, caregivers, clinicians, and social care stakeholders. Potential care recipients are identified using routine patient-reported outcomes (DANBIO) and functional limitation triggers (MDHAQ), screened for frailty with the Clinical Frailty Scale (CFS), and their nominated informal caregivers are screened for burden using the Caregiver Burden Scale (CBS). The approximately 12-week intervention is delivered by trained rheumatology healthcare professionals and consists of three structured contacts including a 60–90 minute initial consultation and shorter follow-ups. This feasibility study tests acceptability, delivery procedures, and recruitment pathways to inform a future definitive trial.
Who should consider this trial
Good fit: Ideal participants are unpaid caregivers aged 18 or older who care for a person aged 65+ with confirmed RA and frailty (CFS ≥ 5) and who report at least moderate caregiver burden (mean CBS > 1.99).
Not a fit: Caregivers with low reported burden, those with severe cognitive impairment or an acute mental health crisis, or caregivers of patients who are not frail or are under 65 are unlikely to benefit.
Why it matters
Potential benefit: If successful, the program could reduce caregiver burden, improve caregivers' ability to manage care and access services, and indirectly support better outcomes for frail older adults with RA.
How similar studies have performed: Caregiver support interventions in other chronic conditions have shown mixed benefits, and this RA-and-frailty–specific, co-created program is novel and has not yet been tested in a definitive trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Glostrup Municipality, Capital Region
- Rigshospitalet, Center for Rheummatology and Spine Diseases — Glostrup Municipality, Capital Region, Denmark (Recruiting)
Study contacts
- Principal investigator: Bente Esbensen, Professor — Glostrup University Hospital, Copenhagen
- Study coordinator: Luise Lindgren, Ph.D.
- Email: luise.holberg.lindgren@regionh.dk
- Phone: 22509390
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.