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

Feasibility Clinical Trial

Official title:

Newly Diagnosed With Inflammatory Arthritis - a Self-management Intervention (NISMA) A Descriptive Randomized Controlled Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06063252
• Other study ID #: GlostrupUHN
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: April 23, 2023

Study information

• Verified date: September 2023
• Source: Glostrup University Hospital, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: April 23, 2023
• Est. primary completion date: April 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Exclusion Criteria:

• Insufficient language skills to discuss the topics in the intervention in Danish

• In chemotherapy treatment for malignancies

Related Conditions & MeSH terms

• Arthritis
• Feasibility

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Denmark	Luise Holberg Lindgren	Glostrup	Region Hovedstaden

Sponsors (1)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment	Recruitment rate will be assessed as the number of patients recruited out of the number of eligiable patients	Assessed at 3 months
Primary	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
Primary	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	Physical activity measured by the Physical activity and sedentary time questionnaire (FAST)	Physical activity measured by the Physical activity and sedentary time questionnaire (FAST)	Assessed at baseline and 9 months
Secondary	Pain intensity measured by the Visual analog scale for pain (VAS)	Pain measured by the Visual analog scale for pain. Score from 0-100. Higher score is more pain.	Assessed at baseline and 9 months
Secondary	Functional status measured by the Multi-Dimensional Health Assessment Questionnaire (MD-HAQ)	Functional status measured by the Multi-Dimensional Health Assessment Questionnaire. Score from 0-3. Higher score is more disability.	Assessed at baseline and 9 months
Secondary	Fatigue measured by the Bristol Reumatoid Arthritis Fatigue Questionnaire (BRAF)	Fatigue measured by the Bristol Reumatoid Arthritis Fatigue Questionnaire (BRAF). It consists of 20 questions with four responses in four categories: physical fatigue, living with fatigue, cognitive fatigue, and emotional fatigue. Higher score is more fatigue.	Assessed at baseline and 9 months
Secondary	Fatigue measured by the visual analog scale for fatigue (VAS-fatigue)	Fatigue measured by the visual analog scale for fatigue (VAS-fatigue). Score from 0-100. Higher score is more fatigue.	Assessed at baseline and 9 months
Secondary	Health Literacy was measured by the Health Literacy Questionnaire (HLQ)	Health Literacy was measured by the Health Literacy Questionnaire. Independent scales measuring health literacy on a continuous scale. Scores range between 1 to 4 (for first 5 scales) and 1 to 5 (for scales 6 to 9).	Assessed at baseline and 9 months
Secondary	Health related quality of life measured by the EuroQol-5 Dimension (EQ5D)	Quality of life measured by the EuroQol-5 Dimension. measures the patient's self-rated health status. Ranging from -0.624 to 1, higher is better.	Assessed at baseline and 9 months
Secondary	Illness perception measured by the Brief Illness Perception Questionnaire (B-IPQ)	Illness perception measured by the Brief Illness Perception Questionnaire. Score from 1-10. Higher is worse.	Assessed at baseline and 9 months
Secondary	Self-efficacy measured by the Arthritis specific self-efficacy measurement tool (ASES)	Self-efficacy measured by the Arthritis specific self-efficacy measurement tool. Score from 1-10. Higher score is better	Assessed at baseline and 9 months
Secondary	Anxiety and depression measured by the Hospital Anxiety and Depression Scale (HADS)	Anxiety and depression measured by the Hospital Anxiety and Depression Scale. ). HADS is a 14-item questionnaire that assesses levels of anxiety and depression symptoms in medically ill patients in two 7-item sub-scales, one for anxiety (HADS-A) and one for depression (HADS-D). Scores of 8 to 10 suggest the presence of a mood disorder. Scores of 11 or higher indicate the probable presence of a mood disorder. Symptoms of anxiety and depression were defined by scores of 8 or higher.	Assessed at baseline and 9 months
Secondary	Disease activity RA measured the Disease Activity Score in 28 joints (DAS28)	Disease activity in rheumatoid arthritis, measured the Disease Activity Score in 28 joints with erythrocyte sedimentation rate. Composite measures, in which multiple aspects of the disease are combined in a total score of the level of disease activity. Higher is worse.	Assessed at baseline and 9 months
Secondary	Disease activity SpA measured by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	Disease activity in patients with spondyloarthritis, was measured by the Bath Ankylosing Spondylitis Disease Activity Index. The sum score ranges from 0 to 100 with higher values indicating more active disease	Assessed at baseline and 9 months
Secondary	Disease activity PsA measured by the the Disease Activity index for PSoriatic Arthritis (DAPSA).	Disease activity in patients wiht psoriatic arthritis, was measured by the Disease Activity index for PSoriatic Arthritis. Composite measures, in which multiple aspects of the disease are combined in a total score of the level of disease activity. Higher is worse.	Assessed at baseline and 9 months