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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. [ABSTRACT FROM AUTHOR]

Background: The traditional system of routine outpatient follow-up of chronic disease in secondary care may involve a waste of resources if patients are well. The use of patient-reported outcomes (PRO) could support more flexible, cost-saving follow-up activities. AmbuFlex is a PRO system used in outpatient follow-up in the Central Denmark Region. PRO questionnaires are sent to patients at fixed intervals. The clinicians use the PRO data to decide whether a patient needs a visit or not (standard telePRO). PRO may make patients become more involved in their own care pathway, which may improve their self-management. Better self-management may also be achieved by letting patients initiate contact. The aim of this study is to obtain data on the effects of patient-initiated follow-up (open access telePRO) on resource utilisation, quality of care, and the patient perspective.Methods: The study is a pragmatic, randomised, controlled trial in outpatients with epilepsy. Participants are randomly assigned to one of two follow-up activities: a) standard telePRO or b) open access telePRO. Inclusion criteria are age ≥ 15 years and previous referral to standard telePRO follow-up at Aarhus University Hospital, Denmark. Furthermore, patients must have answered the last questionnaire via the Internet. The number of contacts will be used as the primary outcome measure. Secondary outcome measures include well-being (WHO-5 Well-Being Index), general health, number of seizures, treatment side effects, mortality, health literacy (Health Literacy Questionnaire), self-efficacy (General Self-Efficacy scale), patient activation, confidence, safety, and satisfaction. In addition, the patient perspective will be explored by qualitative methods. Data will be collected at baseline and 18 month after randomisation. Inclusion of patients in the study started in January 2016. Statistical analysis will be performed on an intention-to-treat and per-protocol basis. For qualitative data, the interpretive description strategy will be used.Discussion: The benefits and possible drawbacks of the PRO-based open access approach will be evaluated. The present study will provide important knowledge to guide future telePRO interventions in relation to effect on resource utilisation, quality of care, and the patient perspective.Trial Registration: ClinicalTrials.gov: NCT02673580 (Registration date January 28, 2016). [ABSTRACT FROM AUTHOR]