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.
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
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.
Parallel
Newly diagnosed with Inflammatory arthritis - a Self-MAnagement intervention (NISMA)
BehavioralThe 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.
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.
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.
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.
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.
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.
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Glostrup University Hospital, Copenhagen
Lead sponsor
Rigshospitalet, Denmark
Sponsor institution
University Hospital Bispebjerg and Frederiksberg
Collaborator
Aarhus University Hospital
Collaborator
