Effect of a Self-Management Intervention for Patients Newly Diagnosed With Inflammatory Arthritis: The NISMA Trial

NCT06533423 | Recruiting DMC

• 1 other identifier: GlostrupUHNrct
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 2

Brief Summary

Background: In patients newly diagnosed with inflammatory arthritis, a self-management intervention is anticipated to enhance self-management skills, thereby improving patient function, well-being, and survival. The primary objective of the trial is to investigate the short-term efficacy of the NISMA intervention and usual care, compared to usual care alone (control group), on self-management skills and techniques in patients newly diagnosed with inflammatory arthritis. Method: This study aims to test the efficacy of the "Newly diagnosed with Inflammatory arthritis - a Self-MAnagement intervention" (NISMA) through a multicenter pragmatic randomized controlled trial (RCT). The trial will involve 130 patients newly diagnosed with IA from three Danish hospitals. Participants will be randomly assigned to either the NISMA intervention group or a control group receiving usual care. The NISMA intervention includes three mandatory individual sessions with a nurse, supplemented by two optional group sessions over 12 months. Primary outcomes will be measured using the Health Education Impact Questionnaire (heiQ), focusing on the "skill and technique acquisition" domain. Secondary outcomes include other heiQ domains, quality of life, loneliness, physical function, pain intensity, pain, self-efficacy, anxiety and depression, fatigue, patient global assessment, disease activity, and medication adherence. Data will be collected at baseline, 12 months, and 18 months post-baseline. Discussion: This RCT will provide essential insights into the effectiveness of a targeted self-management intervention for patients newly diagnosed with IA. The NISMA intervention, developed following the Medical Research Council Framework for complex interventions, aims to improve self-management skills and overall QoL. By addressing the unique challenges faced by newly diagnosed patients, this study seeks to enhance the initial management of IA, aligning with the European Alliance of Associations for Rheumatology (EULAR) recommendations for self-management support. If successful, the NISMA intervention could represent a significant advancement in the non-pharmacological management of IA, offering a comprehensive, patient-centered approach that addresses both physical and psychological needs.

Conditions

Inflammatory Arthritis

Keywords

self-management; rheumatoid arthritis; axial spondyloarthritis; psoriatic arthritis; newly diagnosed; heiQ; quality of life

Outcome Measures

Primary Outcomes (1)

• Primary outcome and endpoint

  The primary outcome measure is self-management skills, assessed by the Health Education Impact Questionnaire (heiQ) - the skill and technique acquisition domain. (Higher score is better). The primary endpoint will be the difference in least squares means between groups, analyzed at 12 months from baseline.

  Baseline-end of intervention (12 months after baseline).

Secondary Outcomes (12)

• Self-management skills measured by the Health Education Impact Questionnaire (heiQ)

  Baseline-end of intervention (12 months after baseline), and 24 months after baseline.

• Health Related Quality of Life

  Baseline-end of intervention (12 months after baseline), and 24 months after baseline.

• Loneliness

  Baseline-end of intervention (12 months after baseline), and 24 months after baseline.

• Physical function

  Baseline-end of intervention (12 months after baseline), and 24 months after baseline.

• Pain Intensity

  Baseline-end of intervention (12 months after baseline), and 24 months after baseline.

Study Arms (2)

controlgroup

NO INTERVENTION

There are no established standards for identifying and addressing self-management needs in rheumatology outpatient consultations. Participants allocated to the control group will receive usual care, which consists of planned sessions with a rheumatologist and occasionally a nurse, a physiotherapist, and an occupational therapist. Those who started DMARDs of any type had an appointment with a nurse and a follow-up phone call. All participants will have the possibility to contact the outpatient clinic and talk to a nurse. Participants in the control group will be encouraged to maintain their usual daily routines and self-management practices until the follow-up assessment is conducted.

intervention group

EXPERIMENTAL

Participants allocated to the intervention group will receive the NISMA Intervention in addition to usual care.

Behavioral: Newly diagnosed with Inflammatory arthritis - a Self-MAnagement intervention (NISMA)

Interventions

Newly diagnosed with Inflammatory arthritis - a Self-MAnagement intervention (NISMA) BEHAVIORAL

The NISMA intervention is a flexible intervention and comprises three mandatory individual sessions with a nurse, supplemented by two optional group sessions over a period of 12 months, to provide comprehensive support tailored to each participant's needs. The intervention is grounded in the theoretical framework Social Cognitive Theory and inspired by the questioning techniques in Acceptance and Commitment Therapy (ACT). These methods play a crucial role in helping participants enhance their self-efficacy. The key components of our approach include: a person-centered approach by addressing challenges identified by each participant to foster self-efficacy through targeted problem-solving and goal-setting. This is utilized by interviewing techniques derived from ACT to assist participants in accepting and committing to self-management. The program is designed to last between 6-12 months, allowing for gradual skill development and adaptation.

intervention group

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients will be included if they are adults aged 18 years or older with one of the following conditions:
• Rheumatoid Arthritis (RA) with ICD-10 codes: M05.3, M05.9, M05.8, M06.9 diagnosed within the last 6 months
• Psoriatic Arthritis (PsA) with ICD-10 codes: M073.A, M073.B diagnosed within the last 6 months
• Axial Spondyloarthritis (axSpA) with ICD-10 codes: M45.9, M46.1, M46.8, M46.9, diagnosed within the last 12 months, and has initiated biological treatment

You may not qualify if:

• Patients will be excluded if they:
• have insufficient language skills to discuss the topics in the intervention in Danish
• are receiving chemo-therapy treatment for malignancies
• are pregnant
• have severe mental illness.

Sponsors & Collaborators

• University Hospital Bispebjerg and Frederiksberg: collaborator
• Aarhus University Hospital: collaborator
• Glostrup University Hospital, Copenhagen: lead

Study Sites (2)

Rigshospitalet, Center for Rheummatology and Spine Diseases

Glostrup Municipality, 2600, Denmark

RECRUITING

Holbæk sygehus

Holbæk, 4300, Denmark

RECRUITING

Related Publications (1)

• Lindgren LH, Thomsen T, Hetland ML, Aadahl M, de Thurah A, Christensen R, Esbensen BA. Effect of a self-management intervention for newly diagnosed inflammatory arthritis: study protocol for a randomized controlled trial. Trials. 2025 Nov 27;26(1):594. doi: 10.1186/s13063-025-09192-z.

  PMID: 41310759 DERIVED

MeSH Terms

Conditions

Arthritis; Arthritis, Rheumatoid; Axial Spondyloarthritis; Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Ankylosis; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases

Study Officials

• Bente A Esbensen

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luise H Lindgren

CONTACT

22509390; luise.holberg.lindgren@regionh.dk

Bente A Esbensen

CONTACT

38624056; bente.appel.esbensen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the NISMA intervention blinding of participants is impossible. However, the outcome assessor will be blinded, and participants will be asked not to disclose their group to the assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomization, allocation, and blinding Randomization 1:1 will be performed after baseline assessments and conducted using a computerized random number generator algorithm by the project manager. Randomization will be stratified by site. Therefore, a customized randomization table will be uploaded for each site to REDCap (Research Electronic Data Capture). The project manager will enroll participants and inform them whether they have been allocated to the intervention group or the control group (see Fig. 2 for participants flow through the trial). For participants randomized to the intervention group, the first individual session will be scheduled as soon as possible after allocation. Due to the character of the intervention, it is not possible neither to blind participants to their allocated intervention nor to blind the HP delivering the intervention. Analysis of data will be performed blinded to group allocation.

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: August 1, 2024
• Study Start: December 9, 2024
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2028
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)