Cardiac Rehabilitation Needs Among Individuals With Atrial Fibrillation

NCT06772207 | Enrolling By Invitation

• 1 other identifier: PRIME-AF
• Study Type: observational
• Target: 30,000
• Locations: 1 country
• Sites: 1

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

Conditions

Atrial Fibrillation (AF)

Keywords

Atrial Fibrillation; Cardiac rehabilitation; Needs; Secondary prevention; Primary care; Survey; Registry

Outcome Measures

Primary Outcomes (2)

• Atrial fibrillation related quality of life

  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.

  At enrollment

• Atrial fibrillation related symptom burden

  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.

  At enrollment

Secondary Outcomes (6)

• General well-being

  At enrollment

• Anxiety

  At enrollment

• Depression

  At enrollment

• Medicine adherence

  At enrollment

• Risk factor status

  At enrollment

Other Outcomes (3)

• General health status

  At enrollment

• Demographic data

  At enrollment

• Outcomes important for the overall assessment of cardiac rehabilitation needs

  At enrollment

Study Arms (1)

Respondents of electronic survey

Population with incident AF in Denmark in 2023-2024

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Registry-based. The study population is drawn from Danish Health Registries and receive an online questionnaire.

You may qualify if:

• 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\*).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Odense University Hospital

Odense, Denmark

Location

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Axel Brandes, Professor, cardiologist

  Department of Cardiology, Esbjerg and Grindsted Hospital - University Hospital of Southern Denmark, Esbjerg, Denmark.

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 13, 2025
• Study Start: June 11, 2025
• Primary Completion: July 14, 2025
• Study Completion: July 14, 2025
• Last Updated: June 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)