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

March 16, 2026 updated by: Bente Appel Esbensen, Glostrup University Hospital, Copenhagen

Protocol for the Feasibility Study of INSPIRE: an Individually Tailored Support Intervention for Informal Caregivers of Older Adults With Rheumatoid Arthritis and Frailty

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study evaluates the feasibility and acceptability of delivering INSPIRE (INtervention to Support Partners and Informal caREgivers of frail RA patients) within routine rheumatology care and tests study procedures to inform a future definitive trial. INSPIRE is an individually tailored support intervention for informal caregivers of older adults with rheumatoid arthritis (RA) and frailty, developed through stakeholder co-creation and designed for implementation in standard outpatient workflows.

Potentially eligible care recipients are identified using routine patient-reported outcomes completed prior to clinic visits (DANBIO). Functional limitation scores (MDHAQ) are used as a pragmatic trigger for further screening. Interested patients are contacted for telephone screening including frailty classification using the Clinical Frailty Scale (CFS). When an eligible patient agrees, they nominate an informal caregiver who is contacted by the study team, provided study information, and screened for caregiver burden using the Caregiver Burden Scale (CBS). Recruitment occurs within a fixed, pre-specified recruitment period.

INSPIRE is delivered by trained healthcare professionals with rheumatology context and experience in psychosocial support and service navigation. The intervention is delivered over approximately 12 weeks and consists of three structured contacts: (1) an initial consultation (about 60-90 minutes), (2) a brief follow-up contact (about 15-30 minutes; typically telephone), and (3) a final consultation (about 30-60 minutes). Delivery mode is flexible (clinic, home, or telephone) to reflect real-world implementation.

The initial consultation follows a structured needs assessment guided by the caregiver's CBS profile and a semi-structured consultation framework to identify the caregiver's priority burden domains. The healthcare professional supports goal setting and action planning and selects relevant elements from a predefined INSPIRE toolbox. Toolbox elements may include validation of the caregiver role; psychoeducation and coping support; practical strategies to reduce day-to-day strain; communication support within the dyad and with services; RA- and frailty-relevant information; and navigation/signposting to health and municipal services (e.g., home care, assistive devices, respite options, social work pathways). The brief follow-up contact reviews progress, identifies barriers, and adjusts the action plan and toolbox elements as needed. The final consultation consolidates strategies used, reviews ongoing support needs, and supports planning for continued access to relevant services. The older adult with RA may optionally participate in selected consultations when preferred by both parties; the caregiver remains the primary intervention recipient.

Feasibility is assessed using descriptive metrics including screening and recruitment flow, retention through follow-up, completeness of questionnaire data, and intervention deliverability (sessions completed, timing, duration, and mode). Acceptability is assessed post-intervention using the Acceptability of Intervention Measure and supplemented by brief structured questions and qualitative interviews with caregivers (and optionally older adults and/or delivering professionals) to explore perceived usefulness and implementation barriers and facilitators. Intervention fidelity and tailoring are documented using structured session notes recording components delivered, toolbox elements selected, caregiver goals, and referrals/signposting.

Analyses are descriptive and focus on feasibility and process outcomes. Candidate outcome measures are summarized at baseline and follow-up to assess completeness and variability; exploratory pre-post changes may be presented without formal hypothesis testing. The intervention is considered low risk; discussions may elicit emotional discomfort, and participants may pause or discontinue at any time. Delivering professionals follow predefined signposting/referral pathways if significant distress is identified. Data are managed securely and reported in anonymized form in accordance with applicable data protection requirements.

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Support intervention
Participants will receive the INSPIRE intervention
Behavioral: Caregiver support
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment rate
Time Frame: 3 months
Recruitment rate will be assessed as the number of caregivers recruited out of the number of eligible caregivers
3 months
Retention rate
Time Frame: 3 months
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
Time Frame: 3 months
Number of sessions completed
3 months
Intervention deliverability
Time Frame: 3 months
Session duration
3 months
Intervention deliverability
Time Frame: 3 months
Session mode
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fidelity
Time Frame: 3 months
Intervention fidelity is estimated based on documentation sheets, filled out after each session by the healthcare professional delivering the intervention
3 months
Data completeness
Time Frame: 3 months
Missing data will be assessed as the number of items answered relative to the total number of items (i.e., item-level completeness)
3 months
Acceptability
Time Frame: 3 months
Acceptability will be assessed using post-intervention acceptability questions
3 months
Health related quality of life
Time Frame: Baseline and 3 months

Quality of life will be measured using the World Health Organization Quality of Life Instrument, Short Form (WHOQOL-BREF). The WHOQOL-BREF is a 26-item, generic quality-of-life instrument covering four domains (physical, psychological, social relationships, and environment) plus two overall items (overall QoL and general health).

Each item is rated on a 5-point Likert scale with values ranging from 1 to 5 (minimum = 1; maximum = 5). Higher scores indicate better quality of life / better perceived health. Domain scores are typically calculated by summing relevant items and transforming to a standardized scale; regardless of transformation, higher domain scores represent better quality of life.
Baseline and 3 months
Physical function
Time Frame: Baseline
Physical function will be assessed using the physical function section of the Multidimensional Health Assessment Questionnaire (MDHAQ). The physical function section (often reported as the MDHAQ Function score) is typically scored from 0 to 3 (minimum = 0; maximum = 3), where higher scores indicate worse physical function (greater disability/limitations).
Baseline
Caregiver burden
Time Frame: Baseline and 3 months
The Caregiver Burden Scale (CBS) is a 22-item self-report questionnaire covering five domains (general strain, isolation, disappointment, emotional involvement, and environment). Each item is rated on a 4-point response scale from 1 to 4, yielding a mean total score ranging from 1 (minimum) to 4 (maximum). Higher scores indicate worse outcome (greater perceived caregiver burden).
Baseline and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glostrup University Hospital, Copenhagen

Investigators

  • Principal Investigator: Bente Esbensen, Professor, Glostrup University Hospital, Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

January 22, 2026

First Submitted That Met QC Criteria

February 24, 2026

First Posted (Actual)

March 2, 2026

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GlostrupUHNinspire

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be shared upon reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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