Clinical trial NCT06772207: Cardiac Rehabilitation Needs Among Individuals with Atrial Fibrillation
Official title: Cardiac Rehabilitation Needs Among Individuals with Atrial Fibrillation. a Protocol for a Danish Survey and Registry-based Study (PRIME-AF)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Atrial Fibrillation (AF)
Keywords: Atrial Fibrillation
Cardiac rehabilitation
Needs
Secondary prevention
Primary care
Survey
Registry
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 26000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Registry-based. The study population is drawn from Danish Health Registries and receive an online questionnaire.

Brief 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.

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.

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.

Primary outcomes:
measure: Atrial fibrillation related quality of life
timeFrame: At enrollment
measure: Atrial fibrillation related symptom burden
timeFrame: At enrollment
Secondary outcomes:
measure: General well-being
timeFrame: At enrollment
measure: Anxiety
timeFrame: At enrollment
measure: Depression
timeFrame: At enrollment
measure: Medicine adherence
timeFrame: At enrollment
measure: Risk factor status
timeFrame: At enrollment
measure: Comorbidity
timeFrame: At enrollment
Other outcomes:
measure: General health status
timeFrame: At enrollment
measure: Demographic data
timeFrame: At enrollment
measure: Outcomes important for the overall assessment of cardiac rehabilitation needs
timeFrame: At enrollment
Locations:
Study officials:
affiliation: Department of Cardiology, Esbjerg and Grindsted Hospital - University Hospital of Southern Denmark, Esbjerg, Denmark.
name: Axel Brandes, Professor, cardiologist
role: STUDY_CHAIR
References: