Professor, PhD, RN
Jette Primdahl
Center for Expertise in Rheumatology, Danish Hospital for Rheumatic Diseases, Sønderborg and Department of Regional Health Research, University of Southern Denmark
| Project management | ||
| Project status | Open | |
| Data collection dates | ||
| Start | 19.08.2024 | |
| End | 31.12.2026 | |
The Efficacy of a Complex INterdisciplinary Nurse-Coordinated SELf-MAnagement (INSELMA) Intervention for People With Substantial Impact from their Inflammatory Arthritis
Short summary
Patients with inflammatory arthritis (IA) experience substantial disease impact despite optimal pharmacological treatment. We thus developed a six-month nurse-coordinated interdisciplinary self-management intervention (INSELMA), in collaboration with patients, clinicians and managers. A feasibility study on the INSELMA intervention in 18 participants showed promising results. We want to confirm these proof of concept findings in a larger randomised trial. Quality of life is the primary outcome.
Rationale
Despite focus on treating inflammation, approximately 30% of patients with inflammatory arthritis (IA) (rheumatoid arthritis, psoriatic arthritis, and spondyloarthritis), still experience substantial impact of their arthritis. Many experience reduced mobility, stiffness, pain, fatigue, sleep disturbances, anxiety, depression and overall diminished quality of life. To be able to manage these challenges effectively, patients require interdisciplinary tailored self-management support. We thus developed a six-month nurse-coordinated interdisciplinary self-management intervention (INSELMA), in collaboration with patients, clinicians and managers. A feasibility study on the INSELMA intervention in 18 participants showed promising results. It is now relevant to confirm these proof of concept findings in a larger trial with a control group. The primary objective of the trial is to compare the efficacy of the INSELMA intervention, relative to usual care, on health related quality of life measured by change in the EQ-5D-5L Visual Analogue Scale from baseline to 12 months after baseline in people with IA and substantial disease impact. Key secondary objective are to compare the efficacy of INSELMA, relative to usual care, on mental well-being, anxiety, depression, fatigue, pain, self-efficacy for managing pain, physical function, global impact of the disease, sleep problems and acceptable symptoms from baseline to 12 months after baseline.
Description of the cohort
This pragmatic RCT will employ a two-group parallel design, with 120 participants randomized into either the INSELMA intervention or usual care. The primary outcome will be change in health-related quality of life (HRQoL) using the EQ-5D-5L index from baseline to week 38, three months after completion of the intervention. Patient reported outcomes will be collected at baseline and 6 and 12 months after baseline. Recruitment will take place at rheumatology outpatient departments at the Danish Hospital for Rheumatic Diseases in Sønderborg, Rigshospitalet-Glostrup, and Frederiksberg Hospital in Copenhagen, Denmark.
Data and biological material
Questionnaire data (sociodemographic and diseaes related information) and patient reported outcomes.
Collaborating researchers and departments
COPECARE, Rigshospitalet-Glostrup and Rheumatology outpatient department at Frederiksberg hospital
- Professor, RN, Bente Appel Esbensen
Publications associated with the project