Cardiac Rehabilitation Needs Among Individuals with Atrial Fibrillation

Not yet recruiting

• Conditions: Atrial Fibrillation (AF)

• Registration Number: NCT06772207
• Lead Sponsor: Odense University Hospital

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.

Study Timeline

• Study First Submitted: 2025-01-02
• Study First Submitted QC: 2025-01-08
• Study First Posted: 2025-01-13
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-24
• Study Start: 2025-05
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 26000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
General well-being	At enrollment	WHO5. The WHO-5 is a five-item scale measuring well-being and life satisfaction within the past 2 weeks and the scale is operationalized using a 0-100 score, with higher values indicating a higher level of well-being and life satisfaction. Scores below 50 indicate poor well-being.
Anxiety	At enrollment	ASS-2 has the purpose of screening for anxiety within the past 2 weeks. Higher score of ASS-2 indicates a higher symptom level of anxiety.
Depression	At enrollment	MDI-2 has the purpose of screening for depression within the past 2 weeks. Higher score indicates a higher symptom level of depression.
Medicine adherence	At enrollment	MARS-5 (Medication Adherence Report Scale). Items scored as 5 = never to 1 = always, i.e. high scores = high adherence. Scores are added together to form a scale score (range = 5 to 25). An adjusted mean score is calculated by dividing the scale mean by the number of items in the scale (range 1-5).
Risk factor status	At enrollment	Obesity, physical inactivity, smoking and alcohol habits
Comorbidity	At enrollment	Hypertension, diabetes, sleep apnoea, other cardiac diseases