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Clinical Trials in Denmark / NCT06772207
Enrolling by invitation Observational

Cardiac Rehabilitation Needs Among Individuals With Atrial Fibrillation

NCT06772207 · tracked via the Priya Life Science Denmark tracker
Sponsor
Odense University Hospital
Phase
Observational
Started
2025-06-11
Last updated
2025-06-25

Condition(s) studied

Atrial Fibrillation (AF)

Study summary

The goal of this survey- and registry-based study is to learn about the cardiac rehabilitation needs of individuals with atrial fibrillation (AF). The main objectives of the study is to:

1. Investigate cardiac rehabilitation needs among eligible individuals with AF in a large AF population
2. Estimate how many needs referral to primary care programs, according to a needs assessment model.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Individuals with recidence in Denmark, 18 years of age or above, with a CPR number (personal identification number) registered with a diagnosis of incident AF in 2022 or 2023 (ICD-10: DI480\*). Exclusion Criteria: * Death. * Name- and address protection. * Exemtion from using digital post. * Living in a nursing home. * A diagnosis of dementia. * Hospital admission or ambulant contacts due to mental illness within one year before diagnosis (except depression or anxiety). * Individuals receiving palliative care or treatment.

Primary outcome measure(s)

  • Atrial fibrillation related quality of life — At enrollment
    Atrial fibrillation related quality of life by ASTA HRQoL scale (The Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia). The ASTA HRQoL scale has 13 items and describes the arrhythmia's influence on daily life situation with a seven items physical subscale (items 1-5, 10 and 12) and a six items mental subscale (items 6-9, 11 and 13). We will be using both the total and subscale scores as recommended. The response alternatives from 0 to 3: "No (0), Yes, to a certain extent (1), Yes, quite a lot (2), Yes, a lot (3)". Scoring for the ASTA HRQoL total scale ranges from 0 (best possible HRQoL) to highest 39 (worst possible HRQoL). Higher scores reflect a worse effect on HRQoL due to the heart rhythm disturbance. ASTA's physical subscale ranges from 0 to 21 and the mental subscale ranges from 0 to18.
  • Atrial fibrillation related symptom burden — At enrollment
    AF6 questionnaire. Patients chose a number on a Likert scale from 0 to 10, where 0 means no and 10 severe symptoms or difficulties. The scores of the six questions are added into a single global score. The recall period for the instrument is the most recent 7 days.

Trial sites (1)

FacilityCityRegionStatus
Odense University Hospital Odense Denmark

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Other trials for the same condition

Study for the Identification of Subclinical Atrial Fibrillation In Patients With Significant Primary Mitral Regurgitation Starting soon
Comprehensive LEFt Atrial Appendage Occlusion With Rhythm Restoration Recruiting
Somatic Health Screening for Adults in Outpatient Psychiatric Care in Denmark (SomaScreen) Recruiting
Clinical Phase 2 Trial of AP31969 Versus Placebo for Rhythm Control of Atrial Fibrillation Recruiting
Stroke Risk Assessment and Markers of Blood Clotting in Patients With Newly Diagnosed Non-valvular Atrial Fibrillation (NVAF), Who Have Not Received Oral Anticoagulation Therapy (OAC-therapy) Prior to Inclusion Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06772207 on ClinicalTrials.gov ↗ ← All trials in Denmark