A self-management intervention for newly diagnosed with inflammatory arthritis: a randomized controlled feasibility and fidelity study.

BACKGROUND

Inflammatory arthritis affects approximately 2-3% of adults worldwide. For patients newly diagnosed with arthritis, effective self-management is crucial, as they often face several physiological, emotional, and social challenges. A self-management intervention called NISMA was thus developed to cater to this group. This study aimed to evaluate the feasibility and fidelity of this 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 expected to be sufficient for assessing the feasibility outcomes. The control group received only the usual care, while the intervention group received the NISMA intervention in addition, which involved individual and group sessions in a multidisciplinary setting. Feasibility was evaluated based on the recruitment, data collection, retention, and randomization processes. The patient-reported outcome measures and clinical measures were collected to review their potential for inclusion in a future randomized controlled trial. Fidelity was assessed by using documentation sheets filled in by the health professionals and audio recordings of the sessions to examine whether the intervention's principles and components were adequately addressed.

RESULTS

Among 47 eligible patients, we recruited 23 participants during a period of 4 months. The recruitment rate was 47% and the retention rate 91%. Randomization, although accepted, led to some disappointment in the control group. Data collection was effective, with only minimal missing data (< 1%). The fidelity was considered as high, as results indicated that nurses effectively engaged in collaborative partnerships with patients, utilizing planned questioning techniques and self-management strategies for problem-solving and resource utilization. However, action planning was inconsistently applied.

CONCLUSION

The study demonstrated the feasibility and the overall high fidelity of delivering the NISMA intervention to patients newly diagnosed with inflammatory arthritis. The insights from the study are useful for identifying the areas that require modifications before initiating a randomized controlled trial.

TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT06063252. Registered 02 October 2023 - retrospectively registered.