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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2023-04-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT06533423

Inflammatory Arthritis

RECRUITING NA

INSELMA - a Randomised Controlled Trial

NCT06583980

Rheumatoid Arthritis Psoriatic Arthritis Axial Spondyloarthritis

RECRUITING NA

Psychosocial Treatment Intervention in Persons Newly Diagnosed With Rheumatoid Arthritis or Diabetes

NCT01066130

Diabetes Mellitus Arthritis, Rheumatoid Coping Skills

COMPLETED NA

Effects of a Rheumatoid Arthritis Self-management Program

NCT03470740

Arthritis, Rheumatoid

COMPLETED NA

Arthritis Self-Management Education Program

NCT00467064

Arthritis

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

RATIONALE FOR NISMA PROJECT

The hypothesis is that a self-management intervention can help patients develop behavioral and emotional strategies to manage life with arthritis. There a lack of disease-specific evidence, in integrated interventions with multiple components targeting patients with a newly diagnosed IA. Therefore, the investigators wish to develop a self-management intervention.

Aim

The overall aim of this study is to determine whether a full-scale randomized controlled trial, which aims to increase self-management in patients with newly diagnosed IA, is possible. The investigators wish to identify methodological, clinical, and procedural uncertainties in delivering a self-management intervention. Furthermore, to investigate outcomes related to recruitment, including adherence, retention, accrual rate, characteristics of the sample, and reliable recruitment methods.

Design

This feasibility study is designed as a randomized controlled feasibility trial (allocation ratio 1:1) to assess the proposed method in the definitive RCT.

Overall Setting

The intervention will take place at the Center for Rheumatology and Spine Diseases, Rigshospitalet, Denmark.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Feasibility

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

controlgroup

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

intervention group

receive self-management intervention

Group Type EXPERIMENTAL

NISMA

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

NISMA

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 Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.