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Background: Inflammatory arthritis affects approximately 1-2% of adults worldwide. Effective self-management is crucial for these patients, especially those newly diagnosed, as they often face both physiological challenges along with emotional, and social challenges [1]. Despite the existence of self-management interventions, their efficacy is limited, with none specifically targeting newly diagnosed patients with IA. Therefore, a tailored self-management intervention, NISMA, was developed for this group [2].
Objectives: In this study, we aimed to evaluate the feasibility and fidelity of the intervention before conducting a full-scale randomized controlled trial.
Methods: This feasibility study was conducted as a single-center randomized controlled trial. Twenty participants were anticipated to be sufficient for assessing feasibility outcomes. The control group received usual care, while the intervention group received the NISMA intervention in addition. The intervention consisted of both individual and group sessions in a multidisciplinary setting (Figure 1). The intervention spans a nine-month duration and was rooted in Social Cognitive Theory [3] supplemented by elements of Acceptance and Commitment Therapy (ACT) [4] to enhance self-efficacy.
Feasibility was evaluated based on recruitment, data collection, retention, and randomization processes. Patient-reported outcome measures and clinical measures were collected to review their potential for inclusion in a future randomized controlled trial. Data were collected at baseline and after the 9-month intervention, and descriptive statistics were employed for analysis.
Fidelity was assessed through documentation sheets and audio recordings of the sessions, examining whether the intervention’s principles (as decision making, problem-solving, and action planning) and components were adequately addressed by the healthcare professionals.
Results: Among 47 eligible patients, we recruited 23 participants during a period of 6 months. We effectively recruited patients with rheumatoid arthritis, and psoriatic arthritis, but encountered challenges for those with axial spondyloarthritis. All participants completed the initial assessments, but three in total were lost to follow-up. Patients who completed the intervention attended all sessions. Although randomization was accepted, it led to some disappointment in participants allocated to the control group. Data collection was effective with minimal missing data. Fidelity results indicated that nurses effectively engaged in collaborative partnerships with patients, utilizing planned questioning techniques (ACT) and self-management strategies for problem-solving and resource utilization. However, there were inconsistent applications of action planning by the nurses.
Conclusion: The study demonstrated feasibility and overall high fidelity of delivering the NISMA intervention. These insights are useful for identification of areas in need of adjustment before initiating a randomized controlled trial.
REFERENCES: [1]
[2]
[3]
[4]
The NISMA intervention
Acknowledgements: We would like to thank the involved patients and healthcare professionals for their valueble contribution.
Disclosure of Interests: Luise Lindgren: None declared, Tanja Thomsen: None declared, Merete L. Hetland Speaker for Pfizer, Medac, Sandoz (no personal income), Research grants (institution) from Abbvie, Biogen, BMS, Celltrion, Eli Lilly, Janssen Biologics B.V, Lundbeck Fonden, MSD, Medac, Pfizer, Roche, Samsung Biopies, Sandoz, Novartis, Nordforsk, Mette Aadahl: None declared, Sara Kristensen: None declared, Annette de Thurah: None declared, Bente Appel Esbensen: None declared.