Newly Diagnosed With Inflammatory Arthritis - a Self-management Intervention (NISMA)

NCT06063252 | Completed DMC

• 1 other identifier: GlostrupUHN
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

Even though medical treatment has improved within the last 10-15 years, patients with inflammatory arthritis (IA) still experience reduced quality of life, depression, anxiety, changes in family roles, work life, and social relationships. Particularly the newly diagnosed, require regular consultations and available support from health professionals, to be able to handle emotional, social, and physiological challenges. The hypothesis is that a self-management intervention can improve patients' ability to monitor their arthritis and respond to symptoms, reduce the risk of co-morbidities, and improve adherence. And also, that they can develop cognitive, behavioral, and emotional strategies to manage life with arthritis. There is a lack of disease-specific evidence, in integrated interventions with multiple components targeting patients with a newly diagnosed IA. In a previous study, the investigators developed a self-management intervention, and now wish to test it in a randomized feasibility study.

Conditions

Feasibility

Outcome Measures

Primary Outcomes (3)

• Recruitment

  Recruitment rate will be assessed as the number of patients recruited out of the number of eligiable patients

  Assessed at 3 months

• Retention

  Retention rate will be assessed as the number of patients who wtihdrew from the study out of the total number of patients.

  Assessed at 9 months

• Adherence

  Adherence to intervention protocol of the study assessed as the number of sessions attended out of the total number of sessions available

  Assessed at 9 months

Secondary Outcomes (13)

• Physical activity measured by the Physical activity and sedentary time questionnaire (FAST)

  Assessed at baseline and 9 months

• Pain intensity measured by the Visual analog scale for pain (VAS)

  Assessed at baseline and 9 months

• Functional status measured by the Multi-Dimensional Health Assessment Questionnaire (MD-HAQ)

  Assessed at baseline and 9 months

• Fatigue measured by the Bristol Reumatoid Arthritis Fatigue Questionnaire (BRAF)

  Assessed at baseline and 9 months

• Fatigue measured by the visual analog scale for fatigue (VAS-fatigue)

  Assessed at baseline and 9 months

Study Arms (2)

controlgroup

NO INTERVENTION

Usual care

intervention group

EXPERIMENTAL

receive self-management intervention

Behavioral: NISMA

Interventions

NISMA BEHAVIORAL

The intervention NISMA is a nine-month intervention and consisted of four individual sessions and two group sessions. The theoretical frame is Social Cognitive Theory, along with Acceptance and Commitment Therapy (ACT), to support the enhancement of self-efficacy. It involves four individual face-to-face sessions with a nurse and two group sessions (5-7 patients) with a nurse, an occupational therapist (OT), and a physiotherapist (PT), with the nurse being the facilitator. Every session has a specific topic and, in every session, a person-centered approach was used to address current problems and secure relevance. Participants in the control group receive usual care, and the intervention group receives both usual care supplemented with the intervention.

intervention group

Eligibility Criteria

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

You may qualify if:

• Adult persons (≥18 years)
• Diagnosed with one of the following diagnoses: Rheumatoid arthritis (ICD10 diagnoses: M05.3, M05.9, M05.8, M06.9), Spondyloarthritis (ICD10 diagnoses: M45.9, M46.1, M46.8, M46.9) or Psoriatic arthritis (ICD10 diagnoses: M073.A, M073.B), within the last 6 months.

You may not qualify if:

• Insufficient language skills to discuss the topics in the intervention in Danish
• In chemotherapy treatment for malignancies

Sponsors & Collaborators

• Glostrup University Hospital, Copenhagen: lead

Study Sites (1)

Luise Holberg Lindgren

Glostrup Municipality, Capital Region, 2600, Denmark

Location

Related Publications (1)

• Lindgren LH, Thomsen T, Hetland ML, Aadahl M, Kristensen SD, de Thurah A, Esbensen BA. A self-management intervention for newly diagnosed with inflammatory arthritis: a randomized controlled feasibility and fidelity study. Pilot Feasibility Stud. 2025 Feb 11;11(1):15. doi: 10.1186/s40814-025-01601-z.

  PMID: 39934926 DERIVED

Study Officials

• Bente A Esbensen, Professor

  Rigshospitalet, Glostrup, Center for Rheumatology and Spine Diseases. COPECARE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This feasibility study is designed as a randomized controlled feasibility trial (allocation ratio 1:1)

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: October 2, 2023
• Study Start: November 1, 2021
• Primary Completion: April 23, 2023
• Study Completion: April 23, 2023
• Last Updated: October 2, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)