Intervention to Support Partners and Informal Caregivers of Frail RA-patients

NCT07442773 | Recruiting

• 1 other identifier: GlostrupUHNinspire
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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-creation process involving older adults with RA and frailty, caregivers, healthcare professionals, and social care stakeholders. Before a definitive evaluation, feasibility and acceptability in routine care must be established. Aim To evaluate the feasibility and acceptability of delivering INSPIRE in routine rheumatology care and to test study procedures in preparation for a future definitive trial. Methods This is a single-arm feasibility study recruiting 25 informal caregivers of older adults with RA and frailty. Recruitment will occur within a fixed four-month window (1 March-1 July 2026) and will not be extended. Care recipients (older adults) will be ≥65 years with RA and frailty classified as Clinical Frailty Scale (CFS) 4-7. Caregivers will be ≥18 years, provide unpaid support, and report at least moderate burden defined as a Caregiver Burden Scale (CBS) mean score \>1.99 at screening. Participants will be recruited from Rigshospitalet (Center for Rheumatology and Spine Diseases) and rheumatology departments in Køge, Slagelse, and Holbæk. Identification uses routine patient-reported outcomes (DANBIO) with invitation of potentially frail patients (e.g., MDHAQ \>1.0) followed by telephone screening and CFS assessment; eligible patients nominate a caregiver who is then screened using CBS. Intervention INSPIRE is delivered by a trained healthcare professional over \~12 weeks and comprises three contacts: an initial consultation (60-90 min), a brief follow-up (15-30 min), and a final consultation (30-60 min). Content is tailored using a toolbox addressing validation of the caregiver role, emotional/practical support, education, communication, and navigation across health and municipal services. Involvement of the older adult in consultations is optional and based on preferences of both parties. Outcomes Feasibility outcomes include recruitment (screened/eligible/consented), retention at 12 weeks, questionnaire completeness, and deliverability (session completion, mode, duration). Acceptability will be assessed post-intervention using the Acceptability of Intervention Measure and supplemented by brief acceptability/feasibility questions and qualitative interviews. Fidelity and tailoring will be documented using structured session notes. Exploratory outcomes include caregiver burden measured by Caregiver burden scale, quality of life measured by WHOQOL-BREF (caregiver and older adult), and physical function measured by MDHAQ . Progression criteria Pre-specified criteria include approximately 50% recruitment of those approached, ≥85% retention, and high fidelity, reviewed using a trafficlight approach (go/amend/stop). Ethics and dissemination Written informed consent will be obtained from both the older adult and the caregiver prior to baseline data collection, with separate consent for any study components each participant takes part in (e.g., consultations, interviews). Findings will be disseminated through peer-reviewed publication, conferences, and stakeholder summaries.

Conditions

Rheumatic Arthritis

Keywords

Frailty; RA; older adults; caregivers; support

Outcome Measures

Primary Outcomes (5)

• Recruitment rate

  Recruitment rate will be assessed as the number of caregivers recruited out of the number of eligible caregivers

  3 months

• Retention rate

  Retention rate will be assessed as the number of participants who withdrew from the study out of the total number of participants.

  3 months

• Intervention deliverability

  Number of sessions completed

  3 months

• Intervention deliverability

  Session duration

  3 months

• Intervention deliverability

  Session mode

  3 months

Secondary Outcomes (6)

• Fidelity

  3 months

• Data completeness

  3 months

• Acceptability

  3 months

• Caregiver burden

  Baseline and 3 months

• Health related quality of life

  Baseline and 3 months

Study Arms (1)

Support intervention

EXPERIMENTAL

Participants will receive the INSPIRE intervention

Behavioral: Caregiver support

Interventions

Caregiver support BEHAVIORAL

Intervention: INSPIRE INSPIRE is delivered by a trained healthcare professional with rheumatology expertise and experience in psychosocial support and service navigation. The intervention runs over approximately twelve weeks and includes an initial consultation, follow-up, and a final consultation. The initial consultation (about 60-90 minutes) takes place at home or in the clinic and is guided by the caregiver's CBS pro-file. It focuses on recognizing and validating the caregiver role, identifying the most burdensome is-sues, exploring underlying causes, and establishing realistic goals. Based on the needs identified, the caregiver is introduced to a tailored toolbox of resources and referral pathways that may include emotional or psychological support options, guidance on managing practical and physical strain, support for social isolation, communication and relationship support, disease-related education, and assistance navigating municipal and health system services.

Support intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Aged ≥ 65 years
• Confirmed diagnosis of RA
• Meets frailty eligibility in routine care, defined as Clinical Frailty Scale (CFS) ≥ 5

You may not qualify if:

• Severe cognitive impairment preventing participation
• Acute mental health crisis
• Other circumstances making it impracticable to complete the intervention and follow-up assessments

Sponsors & Collaborators

• Glostrup University Hospital, Copenhagen: lead

Study Sites (1)

Rigshospitalet, Center for Rheummatology and Spine Diseases

Glostrup Municipality, Capital Region, 2600, Denmark

RECRUITING

MeSH Terms

Conditions

Rheumatic Fever; Frailty

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bente Esbensen, Professor

  Glostrup University Hospital, Copenhagen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luise Lindgren, Ph.D.

CONTACT

22509390; luise.holberg.lindgren@regionh.dk

Signe Abild, Master of Science

CONTACT

signe.marie.abild@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: March 2, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)