Cardiac Rehabilitation Needs Among Individuals With Atrial Fibrillation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation (AF). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Cardiac Rehabilitation Needs Among Individuals With Atrial Fibrillation. A Protocol for a Danish Survey and Registry-based Study (PRIME-AF)
Overview
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.
Detailed description
Atrial fibrillation (AF) is the most common cardiac arrhythmia in adults globally. It poses significant public health challenges and is associated with substantial morbidity and mortality. AF affects quality of life with an enlarged symptom burden. To improve life expectancy and quality of life, medical treatment along with risk factor management and cardiac rehabilitation is needed. In many countries, referral to cardiac rehabilitation remains low. Furthermore, no guidelines or evidence provides details on whom should be referred. Thus, we do not know how many individuals with AF presents with cardiac rehabilitation needs.
This study is a survey and registry-based study. Danish health registries are used to draw a population of individuals with incident AF in 2023-2024. Following the exclusion criteria, these will receive a survey covering the described outcomes which are used to investigate needs of rehabilitation. A statistical predicitive analysis will be performed to estimate how many needs referral to cardiac rehabilitation.
Primary outcome measures
- Atrial fibrillation related quality of life [Time frame: At enrollment]
- Atrial fibrillation related symptom burden [Time frame: At enrollment]
Secondary outcome measures (6)
- General well-being [Time frame: At enrollment]
- Anxiety [Time frame: At enrollment]
- Depression [Time frame: At enrollment]
- Medicine adherence [Time frame: At enrollment]
- Risk factor status [Time frame: At enrollment]
- Comorbidity [Time frame: At enrollment]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Denmark · 1 center
- Odense University Hospital — Odense
Publications
- Elnegaard CM, Borregaard B, Risom SS, Tveskov C, Bech M, von Bornemann Hjelmborg J, Eilso J, Hedegaard AM, Stege Bojer A, Darkner S, Albertsen AE, Joensen AM, Brandes A, Zwisler AD. Cardiac rehabilitation in atrial fibrillation: a protocol for a Danish survey and registry-based study (PRIME-AF). BMJ Open. 2025 Dec 24;15(12):e107042. doi: 10.1136/bmjopen-2025-107042. PMID 41448694
Identifiers
NCT: NCT06772207 · PRIME-AF