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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Respondents of electronic survey | Population with incident AF in Denmark in 2023-2024 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| General well-being | 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. | At enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| General health status | 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. |
Inclusion Criteria:
Exclusion Criteria:
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Registry-based. The study population is drawn from Danish Health Registries and receive an online questionnaire.
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| Name | Affiliation | Role |
|---|---|---|
| Axel Brandes, Professor, cardiologist | Department of Cardiology, Esbjerg and Grindsted Hospital - University Hospital of Southern Denmark, Esbjerg, Denmark. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense University Hospital | Odense | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41448694 | Derived | 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. |
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Unless follow-up studies using the same study population is planned later on, data (IPD) will not be shared.
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Anxiety |
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. |
| At enrollment |
| Depression | MDI-2 has the purpose of screening for depression within the past 2 weeks. Higher score indicates a higher symptom level of depression. | At enrollment |
| Medicine adherence | 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). | At enrollment |
| Risk factor status | Obesity, physical inactivity, smoking and alcohol habits | At enrollment |
| Comorbidity | Hypertension, diabetes, sleep apnoea, other cardiac diseases | At enrollment |
| At enrollment |
| Demographic data | Age, gender, civil status, living situation, region of Denmark, educational level, occupational status, ethnicity, socio-economic classification and family disposable income. | At enrollment |
| Outcomes important for the overall assessment of cardiac rehabilitation needs | 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. | At enrollment |
| D013568 |
| Pathological Conditions, Signs and Symptoms |