Support program for partners and informal caregivers of frail older adults with rheumatoid arthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.