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NCT Number: NCT06337045

Atrial Fibrillation, Prevention and Rehabilitation

Evidence shows that people with atrial fibrillation (AF) can benefit from prevention and rehabilitation interventions related to quality of life, lowered anxiety, etc. In this study, a complex prevention and rehabilitation intervention for people with AF was carried out in a Health Center at a Danish municipality in cooperation with the cardiology department at Svendborg Hospital. The study was designed as a feasibility study, with data gathered systematically including focus group interviews and quantitative patient reported outcomes. People with AF were included at the hospital. Eligible participants were offered intervention in the Health Center. Interventions, in accordance with present international guidelines, consisted of physical exercise, patient education, psychosocial support and consultations with health professionals as well as risk factor management. Also, medicinal yoga (MediYoga) were chosen to be part of the intervention due to promising research results within AF. All interventions were optional and based on needs assessment and preferences.

The primary objective was to investigate the feasibility of delivering a complex prevention and rehabilitation intervention for people with AF in a municipal Health Center.

There were the following four secondary objectives:

1. To explore the participant's experiences of participating in the municipality-based complex prevention and rehabilitation intervention. 2. To explore the participant's needs and preferences of the interventions. 3. To explore changes in HRQoL, anxiety and depression. 4. To explore the feasibility of collecting patient reported outcome measures as part of the intervention.

The hypothesis was that the complex prevention and rehabilitation intervention was feasible in a municipality-based set-up, and was well received by people with AF and may contribute to better outcomes in terms of HRQoL, anxiety and depression.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Prevention Rehabilitation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Cardiology, Odense University Hospital, Odense, Region Syddanmark, Denmark

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • the modified European Heart Rhythm Association (mEHRA) score ≥2B.

And at least one of the following risk factors:

  • Hypertension (treatment with >1 drug, diagnosis verified by home-blood pressure measurement, 24-hour ambulatory blood pressure measurement, or consultation blood pressure measurement >160/90mmHg).
  • Diabetes mellitus (HbA1c > 58mmol/mol unless higher values are accepted due to other aspects).
  • Obesity (Body Mass Index > 30).
  • Smoking (active smoker).
  • Alcohol consumption (> 7 units per week for women and > 14 units per week for men (according to the Danish Health Authority guidelines from 2019), or motivation for reduction).
  • Physical inactivity (less than the recommended 30 minutes per day).
  • Known sleep apnea or STOP-bang Sleep Apnea Questionnaire score >3).
  • Symptoms of anxiety or depression evaluated by the Hospital Anxiety and Depression Scale (HADS) > 7.
  • Mental vulnerability defined as self-evaluated burdened life with high perceived stress, small social network, and/or low educational level.

Exclusion criteria

  • ongoing treatment adjustments due to heart failure.
  • ongoing cardiac rehabilitation.
  • dementia, mental illness, language barrier or comorbidity that made it impossible to participate in this study.

Treatment and study plan

Complex prevention and rehabilitation intervention

Behavioral

The complex intervention started and ended with individual consultations with health professionals and furthermore included physical exercise, smoking cessation, alcohol treatment, dietary interventions, AF specific patient education, MediYoga, and/or psychosocial support.

Primary outcomes

  1. HeartQoL

    Time frame: HeartQoL was collected at three time points: T0 (baseline), T1 (end of intervention, an average of 4 months) and T2 (follow-up 2-months later). The intervention phase (T0 to T1) was individual based on needs assessment.

    HeartQoL measures Health-related Quality of Life (HRQoL). HeartQoL contains three scales, a global overall scale and a physical- and emotional sub-scale. It has a 14-item self-assessment scale enabling the respondents to recall how much their heart problem have bothered them during the past four weeks on a 4-point Likert scale from 0-3, where higher score represents better HRQoL. The global score reflects all items and is calculated by dividing the sum of the scored items by the number of scored items. The same principle goes for the physical- and emotional subscales, which respectively holds 10 items and 4 items.

  2. The hospital anxiety and depression scale (HADS)

    Time frame: HADS was collected at three time points: T0 (baseline), T1 (end of intervention, an average of 4 months) and T2 (follow-up 2-months later). The intervention phase (T0 to T1) was individual based on needs assessment.

    HADS measures symptoms of anxiety and depression. HADS is a 14-item self-assessment scale, 7 items for each domain. All items are rated on a 4-point Likert scale, where 0 reflects the positive extreme and 3 reflects the negative extreme of the scale. For each domain a score ranging from 0 to 21 can be obtained, and categorized as "normal" (0-7 points), "possible presence of a disorder" (8-10 points), and "probable presence of a disorder" (11-21 points).

  3. Experience of participating, experiences needs and preferences of interventions

    Time frame: Focus group interviews was conducted at T1 (end of intervention, an average of 4 months).

    These data was obtained from focus group interviews.

  4. Feasibility of collecting patient reported outcomes (PROMs). The PROMs was the HeartQoL and the hospital anxiety and depression scale.

    Time frame: Field notes was collected at T2 (follow-up 2 months later).

    These data was obtained from collecting field notes from Health Professionals conducting the intervention.

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

  • Department of Cardiology, Odense University Hospital, Odense, Denmark.
  • Department of Internal Medicine & Emergency Department, Svendborg Hospital, Odense University Hospital, Svendborg, Denmark.
  • Health Center, Municipality of Svendborg, Svendborg, Denmark.
  • The Danish Heart Association, Funen, and local committee in Svendborg, Denmark

Registry information

Official study title

Atrial Fibrillation and Municipality-based Prevention and Rehabilitation - a Feasibility Study

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 29, 2024
Registry last updated
Mar 29, 2024

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

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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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