Luise Holberg Lindgren, Tanja Thomsen, Merete Lund Hetland, Mette Aadahl, Sara Danshøj Kristensen, Annette de Thurah, Bente Appel Esbensen
{"title":"自我管理干预对新诊断的炎性关节炎：一项随机对照可行性和保真度研究。","authors":"Luise Holberg Lindgren, Tanja Thomsen, Merete Lund Hetland, Mette Aadahl, Sara Danshøj Kristensen, Annette de Thurah, Bente Appel Esbensen","doi":"10.1186/s40814-025-01601-z","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov ID: NCT06063252. Registered 02 October 2023 - retrospectively registered.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"15"},"PeriodicalIF":1.6000,"publicationDate":"2025-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11817759/pdf/","citationCount":"0","resultStr":"{\"title\":\"A self-management intervention for newly diagnosed with inflammatory arthritis: a randomized controlled feasibility and fidelity study.\",\"authors\":\"Luise Holberg Lindgren, Tanja Thomsen, Merete Lund Hetland, Mette Aadahl, Sara Danshøj Kristensen, Annette de Thurah, Bente Appel Esbensen\",\"doi\":\"10.1186/s40814-025-01601-z\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov ID: NCT06063252. 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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.
期刊介绍：
Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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