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Enrolling by Invitation

NCT Number: NCT06772207

Cardiac Rehabilitation Needs Among Individuals With Atrial Fibrillation

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.

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Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Odense University Hospital

Odense, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Atrial fibrillation related quality of life

    Time frame: 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.

  2. Atrial fibrillation related symptom burden

    Time frame: 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 outcomes

  1. General well-being

    Time frame: 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.

  2. Anxiety

    Time frame: 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.

  3. Depression

    Time frame: 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.

  4. Medicine adherence

    Time frame: 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).

  5. Risk factor status

    Time frame: At enrollment

    Obesity, physical inactivity, smoking and alcohol habits

  6. Comorbidity

    Time frame: At enrollment

    Hypertension, diabetes, sleep apnoea, other cardiac diseases

Other outcomes

  1. General health status

    Time frame: At enrollment

    EQ-5D-5L. Responses are coded as single-digit numbers expressing the severity level selected in each dimension. For instance, 'slight problems' (e.g. 'I have slight problems in walking about') is always coded as '2'. The digits for the five dimensions can be combined in a 5-digit code that describes the respondent's health state; for instance, 21111 means slight problems in the mobility dimension and no problems in any of the other dimensions. The EQ VAS records the respondent's overall current health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' (100) and 'The worst health you can imagine' (0). The EQ VAS provides a quantitative measure of the patient's perception of their overall health.

  2. Demographic data

    Time frame: At enrollment

    Age, gender, civil status, living situation, region of Denmark, educational level, occupational status, ethnicity, socio-economic classification and family disposable income.

  3. Outcomes important for the overall assessment of cardiac rehabilitation needs

    Time frame: At enrollment

    Questions regarding family relations, health literacy (HLS-EU-Q12), management of heart disease, previous provided information of cardiac rehabilitation and motivation for these interventions forwardly.

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Official study title

Cardiac Rehabilitation Needs Among Individuals With Atrial Fibrillation. A Protocol for a Danish Survey and Registry-based Study (PRIME-AF)

Acronym: PRIME-AF

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 13, 2025
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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