Cardiac Rehabilitation Needs Among Individuals With Atrial Fibrillation. A Protocol for a Danish Survey and Registry-based Study (PRIME-AF)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 30,000
- 试验地点
- 1
- 主要终点
- Atrial fibrillation related quality of life
研究概览
简要总结
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:
- Investigate cardiac rehabilitation needs among eligible individuals with AF in a large AF population
- Estimate how many needs referral to primary care programs, according to a needs assessment model.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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*).
排除标准
- •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.
结局指标
主要结局
Atrial fibrillation related quality of life
时间窗: 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
时间窗: 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.
次要结局
- General well-being(At enrollment)
- Anxiety(At enrollment)
- Depression(At enrollment)
- Medicine adherence(At enrollment)
- Risk factor status(At enrollment)
- Comorbidity(At enrollment)
研究者
Caroline Matilde Elnegaard
PhD student
Odense University Hospital