TitleA self-management intervention targeted people with newly diagnosed inflammatory arthritis (NISMA)
Background
Physiological and psychological distress is common in people with inflammatory arthritis and is associated with poorer outcomes. Current evidence suggests that tailormade multi-component self-management programmes may improve disease management in people with early arthritis.
Purpose and hypotheses
The overall aim of this study is to develop, test and evaluate a self-management intervention for people newly diagnosed with inflammatory arthritis.
The hypothesis is that the nurse-delivered intervention embedded in an inter-professional team will reduce the “impact of arthritis” in newly diagnosed people.
Design
The study project will include six sub-studies:
- Development of an evidence and theory-based intervention, aiming to increase self-management in newly diagnosed people with inflammatory arthritis
- A feasibility study aiming to evaluate the preliminary intervention, instruments and methods.
- A qualitative evaluation of the feasibility study
- A qualitative follow-up study, aiming to identify self-management skills
- A randomized controlled trial, testing the effectiveness of the final intervention
- A health economic evaluation of the randomized controlled trial
Project group
Bente Appel Esbensen (principal investigator), Luise Holberg Lindgren, Mette Aadahl, Tanja Thomsen, Merete Lund Hetland, Annette de Thurah, Sara Danshøj Christensen
Title:
A self-management intervention targeted people with newly diagnosed inflammatory arthritis (NISMA)
Sub-study 1
Sub-study 1 encompasses the development of an evidence and theory-based intervention, aiming to increase self-management in newly diagnosed people with inflammatory arthritis. The development process is based on the medical research council framework and includes literature reviews of qualitative and quantitative evidence and workshops with health professionals and people with inflammatory arthritis.
Sub-study 2
This feasibility study aims to provide an evaluation of the preliminary intervention. The study is designed as a randomized controlled feasibility trial (allocation ratio 1:1, 15 participants in each group), assessing the method proposed for the final randomized controlled trial, recruitment and retention rates, safety, suitability, and acceptability. Indication of effects on outcome measures, including patient-related outcomes is also explored.
Sub-study 3
A qualitative process evaluation of the intervention and intervention delivery. The intervention delivery is evaluated based on observations of health professionals who deliver the intervention and participants receiving the intervention. The main focus lies on interpersonal aspects, intervention fidelity and how the intervention was tailored to individuals. Relevant thoughts or challenges related to the intervention are explored via semi-structured interviews with both health professionals and participants.
Sub-study 4
This sub-study is a follow-up study aiming to identify newly diagnosed’s self-management skills based on individual, in-depth template-based interviews with all participants in the feasibility study.
Sub-study 5
The final intervention is tested in a randomized controlled trial. The study is designed as a two-arm single-blinded trial of 120 newly diagnosed people, 60 in each group, recruited from the outpatient clinic at Rigshospitalet. The intervention group will receive the self-management intervention and the control group will receive usual care.
Sub-study 6
A health economic evaluation. The cost analysis will report the intervention costs and activities related to the intervention in both the intervention group and control group. Survey and registry-based data on resource use, including services provided in the healthcare sector (primary and secondary care), will be aggregated for everyone in intervals determined by the time of data collection.