Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07442773

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (may include telephone screening)

Outpatient Treatment

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

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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

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