Title
Interdisciplinary nurse-coordinated self-management in people with inflammatory arthritis and substantial impact of their disease (INSELMA)
Background
Many people with inflammatory arthritis struggle with pain, fatigue, poor sleep, physical limitations, anxiety and depression despite optimal pharmacological treatment.
Purpose and hypotheses
To develop and test a nurse-coordinated interdisciplinary rehabilitation intervention to support the self-management ability as add-on to traditional outpatient care for people with inflammatory arthritis and substantial impact of their arthritis.
We expect the intervention to improve the participants’ self-management skills and thereby reduce the impact of the disease and increase quality of life.
Design
The study will include five sub-studies:
- An initial development of a nurse-coordinated, inter-professional, non-pharmacological intervention, drawing on resources from both primary and secondary care, targeting people who have a high disease burden
- A pilot study, testing the feasibility of the intervention in a pre-test-post-test study
- A qualitative evaluation of the intervention and the delivery of the intervention in the feasibility study
- A randomized controlled trial, testing the final adapted intervention
- A health economic evaluation of the final intervention
Project group
Jette Primdahl (principal investigator), Kristine Marie Latocha, Bente Appel Esbensen, Mikkel Østergaard, Ann Bremander, Oliver Hendricks, Kim Jensen, Lena Andersen
Title:
Interdisciplinary nurse-coordinated self-management in people with inflammatory arthritis and substantial impact of their disease (INSELMA)
Sub-study 1
Sub-study 1 is the initial development of an evidence and theory-based inter-professional intervention, aiming to increase self-management in people with inflammatory arthritis, who have a high disease burden despite optimal pharmacological treatment. The development process is based on literature reviews and workshops with patient representatives and relevant healthcare professionals (nurses, rheumatologists, physio- and occupational therapists, and psychologists), including representatives from the primary sector. The resulting intervention will be shaped according to the identified needs for inter-professional support and relevant ways to organize support across primary and secondary healthcare.
Sub-study 2
This is a quantitative feasibility study aiming to evaluate the process, instruments and methods intented for the full-scale randomized controlled trial. The study will be conducted as a pretest-posttest study in 20 people with inflammatory arthritis. All procedures including recruitment, acceptability, transferability, resource use and the intervention itself will be tested. Effects on outcome measures including patient-related outcomes, are also explored.
Sub-study 3
A qualitative evaluation of the intervention and the delivery of the intervention based on observations made by the involved healthcare professionals and participants in the feasibility study. Four focus group interviews are planned; two with healthcare professionals and two with people with inflammatory arthritis. Focus lies on acceptability, experience of benefit, mode of impact and the transferability of the intervention in all parties. Qualitative content analysis will guide the overall analyses.
Sub-study 4
The results from the feasibility study will be used to adapt the intervention to reach a final self-management intervention. The intervention will be tested against ”usual care” in a randomized two-arm single-blinded controlled trial. The randomized controlled trial will take place at Rigshospitalet’s outpatient clinic in Glostrup and at Danish Hospital for Rheumatic Diseases, Sønderborg. Outcomes will be assessed at the end of intervention and 6 and 18 months post-intervention.
Sub-study 5
A health-economic evaluation. The cost analysis will report the intervention costs and activities related to the intervention in both the intervention 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 each individual in intervals determined by the time of data collection.