protocolSection identificationModule nctId: NCT06337045, orgStudyIdInfo id: AF-rehab, briefTitle: Atrial Fibrillation, Prevention and Rehabilitation, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-02-01, primaryCompletionDateStruct date: 2020-06-30, completionDateStruct date: 2020-06-30, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Odense University Hospital, class: OTHER, collaborators name: Department of Cardiology, Odense University Hospital, Odense, Denmark., collaborators name: Health Center, Municipality of Svendborg, Svendborg, Denmark., collaborators name: Department of Internal Medicine & Emergency Department, Svendborg Hospital, Odense University Hospital, Svendborg, Denmark., collaborators name: The Danish Heart Association, Funen, and local committee in Svendborg, Denmark, descriptionModule briefSummary: Evidence shows that people with atrial fibrillation (AF) can benefit from prevention and rehabilitation interventions related to quality of life, lowered anxiety, etc. In this study, a complex prevention and rehabilitation intervention for people with AF was carried out in a Health Center at a Danish municipality in cooperation with the cardiology department at Svendborg Hospital. The study was designed as a feasibility study, with data gathered systematically including focus group interviews and quantitative patient reported outcomes. People with AF were included at the hospital. Eligible participants were offered intervention in the Health Center. Interventions, in accordance with present international guidelines, consisted of physical exercise, patient education, psychosocial support and consultations with health professionals as well as risk factor management. Also, medicinal yoga (MediYoga) were chosen to be part of the intervention due to promising research results within AF. All interventions were optional and based on needs assessment and preferences.The primary objective was to investigate the feasibility of delivering a complex prevention and rehabilitation intervention for people with AF in a municipal Health Center.There were the following four secondary objectives:1. To explore the participant's experiences of participating in the municipality-based complex prevention and rehabilitation intervention.2. To explore the participant's needs and preferences of the interventions.3. To explore changes in HRQoL, anxiety and depression.4. To explore the feasibility of collecting patient reported outcome measures as part of the intervention.The hypothesis was that the complex prevention and rehabilitation intervention was feasible in a municipality-based set-up, and was well received by people with AF and may contribute to better outcomes in terms of HRQoL, anxiety and depression., conditionsModule conditions: Atrial Fibrillation, conditions: Prevention, conditions: Rehabilitation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Eligible participants were diagnosed with AF at the hospital and had symptomatic AF rated by the modified European Heart Rhythm Association (mEHRA) score ≥2B. If the patient was eligible based on the mEHRA-score, at least one of the following risk factors had to be present: hypertension, diabetes, obesity, smoking, excessive alcohol consumption, physical inactivity, sleep apnoea, anxiety, depression, or mental vulnerability., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ACTUAL, armsInterventionsModule interventions name: Complex prevention and rehabilitation intervention, outcomesModule primaryOutcomes measure: HeartQoL, primaryOutcomes measure: The hospital anxiety and depression scale (HADS), primaryOutcomes measure: Experience of participating, experiences needs and preferences of interventions, primaryOutcomes measure: Feasibility of collecting patient reported outcomes (PROMs). The PROMs was the HeartQoL and the hospital anxiety and depression scale., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Cardiology, Odense University Hospital, city: Odense, state: Region Of Southern Denmark, zip: 5000, country: Denmark, geoPoint lat: 55.39594, lon: 10.38831, locations facility: Health Center, Municipality Svendborg, city: Svendborg, state: Region Of Southern Denmark, zip: 5700, country: Denmark, geoPoint lat: 55.05982, lon: 10.60677, hasResults: False