Effect of a Self-Management Intervention for Patients Newly Diagnosed With Inflammatory Arthritis: The NISMA Trial
NCT Number: NCT06533423
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Inflammatory Arthritis
Interventions: BEHAVIORAL: Newly diagnosed with Inflammatory arthritis - a Self-MAnagement intervention (NISMA)
Sponsor: Glostrup University Hospital, Copenhagen
Collaborators: University Hospital Bispebjerg and Frederiksberg|Aarhus University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 140
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2027-09-01
Locations: Luise Holberg Lindgren, Glostrup, Region Hovedstaden, 2600, Denmark

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.

Primary Outcome Measures: 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 Outcome Measures: Self-management skills measured by the Health Education Impact Questionnaire (heiQ), heiQ domains: health-directed activity; positive and active engagement in life; emotional wellbeing; self-monitoring and insight; constructive attitudes and approaches; social integration and support. (Higher score is better). The corresponding endpoints is the between-group difference in least squares means from the 6 heiQ domains after 12 months. Endpoints in the extension study are the between-group difference in least squares means in heiQ domain 1, 2, 3, 4, 5, 6, 7, and 8 after 24 months., Baseline-end of intervention (12 months after baseline), and 24 months after baseline.|Health Related Quality of Life, Health Related Quality of Life measured by European Quality of Life (EQ5D). (Higher score is better). The corresponding endpoint is the between-group difference in least squares means from EQ5D-5L after 12 months. Endpoint in the extension study is between group difference in EQ5D-5L 24 months after baseline., Baseline-end of intervention (12 months after baseline), and 24 months after baseline.|Loneliness, Loneliness will be measured by The Three Item Loneliness Scale ( 3 categories, higher score is worse). The corresponding endpoint is the between-group difference after 12 months. Endpoint in the extension study is between group difference 24 months after baseline., Baseline-end of intervention (12 months after baseline), and 24 months after baseline.|Physical function, Physical function measured by Modified Health Assessment Questionnaire (MHAQ). (Higher score is worse). The corresponding endpoint is the between-group difference in least squares means from MDHAQ after 12 months. Endpoint in the extension study is between group difference in MDHAQ 24 months after baseline., Baseline-end of intervention (12 months after baseline), and 24 months after baseline.|Pain Intensity, Pain Intensity measured by VAS (0-100). (Higher score is worse). The corresponding endpoint is the between-group difference in least squares means from VAS after 12 months. Endpoint in the extension study is between group difference in VAS 24 months after baseline., Baseline-end of intervention (12 months after baseline), and 24 months after baseline.|Pain self-efficacy, Pain self-efficacy measured by the Arthritis specific Self-Efficacy measurement tool (ASES-pain). (Higher score is better). The corresponding endpoint is the between-group difference in least squares means from ASES-pain after 12 months. Endpoint in the extension study is between group difference in ASES-pain 24 months after baseline., Baseline-end of intervention (12 months after baseline), and 24 months after baseline.|Fatigue, Fatigue measured by the Bristol Rheumatoid Arthritis Fatigue Numeric Rating Scale (BRAF-NRS). (Higher score is worse). The corresponding endpoint is the between-group difference in least squares means from BRAF-NRS after 12 months. Endpoint in the extension study is between group difference in BRAF-NRS 24 months after baseline., Baseline-end of intervention (12 months after baseline), and 24 months after baseline.|Fatigue, VAS-fatigue (0-100). (Higher score is worse). The corresponding endpoint is the between-group difference in least squares means from VAS after 12 months. Endpoint in the extension study is between group difference in VAS 24 months after baseline., Baseline-end of intervention (12 months after baseline), and 24 months after baseline.|Patient global, Patient global assessment measured by VAS-Global. (Higher score is worse). The corresponding endpoint is the between-group difference in least squares means from VAS after 12 months. Endpoint in the extension study is between group difference in VAS 24 months after baseline., Baseline-end of intervention (12 months after baseline), and 24 months after baseline|Disease activity, Disease activity will be measured by composite scores depending on the rheumatic diagnoses. For RA: Disease Activity Score in 28 joints (DAS28), for axSpA: the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and for PsA: the Disease Activity index for Psoriatic Arthritis (DAPSA). (Higher score is worse)., Baseline-end of intervention (12 months after baseline), and 24 months after baseline|Medication adherence, Medication adherence will be measured by the Compliance Questionnaire Rheumatology (CQR)-5-item scale. (Higher score is better). The corresponding endpoint is the between-group difference in least squares means from CQR after 12 months. Endpoint in the extension study is between group difference in CQR 24 months after baseline., Baseline-end of intervention (12 months after baseline), and 24 months after baseline|Anxiety and depression, Anxiety and depression will be measured by the Hospital Anxiety and Depression Scale (HADS). (higher score is worse). The corresponding endpoint is the between-group difference in least squares means from HADS after 12 months. Endpoint in the extension study is between group difference in HADS 24 months after baseline., Baseline-end of intervention (12 months after baseline), and 24 months after baseline