Actively Recruiting
Protocol for the Feasibility Study of INSPIRE: Tailored Support for Informal Caregivers of Older Adults with Rheumatoid Arthritis and Frailty
Led by Glostrup University Hospital, Copenhagen · Updated on 2026-03-17
25
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the feasibility and acceptability of INSPIRE, a support program designed for informal caregivers of older adults with rheumatoid arthritis (RA) and frailty. This intervention was developed with input from patients, caregivers, healthcare professionals, and social care stakeholders to address the unique challenges faced by caregivers, such as emotional strain and practical difficulties. The study aims to test INSPIRE in routine rheumatology care and prepare for a larger definitive trial. INSPIRE is delivered over about 12 weeks by trained healthcare professionals experienced in rheumatology and psychosocial support. It includes three contacts: an initial 60-90 minute consultation, a 15-30 minute follow-up, and a final 30-60 minute consultation. The content is tailored to the caregiver's needs using a toolbox of resources, including emotional support, education, communication help, and guidance for navigating health and municipal services. Delivery can occur at home, in clinic, or by phone, and the care recipient may join consultations if both parties agree. During the study, caregivers will complete questionnaires and participate in consultations to assess feasibility measures like recruitment, retention, session completion, and intervention acceptability. Researchers will also explore caregiver burden, quality of life, and physical function at baseline and follow-up. The study will use qualitative interviews and structured notes to evaluate how well the intervention is delivered and tailored. Participation involves about 3 months of follow-up and assessments designed to inform future trials.
CONDITIONS
Brief Title
Intervention to Support Partners and Informal Caregivers of Frail RA-patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Informal (unpaid) caregiver of an older adult with confirmed rheumatoid arthritis
- Caregiver aged 18 years or older
- Care recipient aged 65 years or older
- Able to provide informed consent
- Able to complete study questionnaires
- Reports at least moderate caregiver burden, defined as mean CBS score greater than 1.99 at screening
- Care recipient aged 65 years or older
- Confirmed diagnosis of rheumatoid arthritis
- Care recipient meets frailty criteria with Clinical Frailty Scale (CFS) score 5 or higher
You will not qualify if you...
- Severe cognitive impairment preventing participation
- Acute mental health crisis
- Other circumstances making it impracticable to complete the intervention and follow-up assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (may include telephone screening)
Duration - Approximately 12 weeks
Participants receive the INSPIRE intervention, a tailored support program for informal caregivers of older adults with rheumatoid arthritis and frailty. The intervention includes three structured contacts delivered by trained healthcare professionals: an initial consultation, a brief follow-up contact, and a final consultation. These sessions focus on assessing caregiver needs, goal setting, support strategies, and planning for ongoing access to services.
3 visits (combination of in-person, home, or telephone)
Trial Site Locations
Total: 1 location
1
Rigshospitalet, Center for Rheummatology and Spine Diseases
Glostrup Municipality, Capital Region, Denmark, 2600
Actively Recruiting
Research Team
L
Luise Lindgren, Ph.D.
S
Signe Abild, Master of Science
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1