TY - JOUR
T1 - A self-management intervention for newly diagnosed with inflammatory arthritis
T2 - a randomized controlled feasibility and fidelity study
AU - Lindgren, Luise Holberg
AU - Thomsen, Tanja
AU - Hetland, Merete Lund
AU - Aadahl, Mette
AU - Kristensen, Sara Danshøj
AU - de Thurah, Annette
AU - Esbensen, Bente Appel
PY - 2025/12
Y1 - 2025/12
N2 - 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.
AB - 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.
KW - Axial spondyloarthritis
KW - Feasibility
KW - Fidelity
KW - Psoriatic arthritis
KW - Rheumatoid arthritis
KW - Self-management
UR - http://www.scopus.com/inward/record.url?scp=85218629495&partnerID=8YFLogxK
U2 - 10.1186/s40814-025-01601-z
DO - 10.1186/s40814-025-01601-z
M3 - Journal article
C2 - 39934926
AN - SCOPUS:85218629495
SN - 2055-5784
VL - 11
JO - Pilot and Feasibility Studies
JF - Pilot and Feasibility Studies
IS - 1
M1 - 15
ER -