Atrial Fibrillation, Prevention and Rehabilitation

NCT06337045 | Completed

• 1 other identifier: AF-rehab
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Atrial Fibrillation; Prevention; Rehabilitation

Outcome Measures

Primary Outcomes (4)

• HeartQoL

  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.

  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.

• The hospital anxiety and depression scale (HADS)

  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).

  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.

• Experience of participating, experiences needs and preferences of interventions

  These data was obtained from focus group interviews.

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

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

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

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

Study Arms (1)

Complex prevention and rehabilitation intervention (single arm)

EXPERIMENTAL

It was a single-arm study.

Behavioral: Complex prevention and rehabilitation intervention

Interventions

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.

Complex prevention and rehabilitation intervention (single arm)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (2)

Department of Cardiology, Odense University Hospital

Odense, Region Syddanmark, 5000, Denmark

Location

Health Center, Municipality Svendborg

Svendborg, Region Syddanmark, 5700, Denmark

Location

Related Publications (1)

• Elnegaard CM, Pedersen MK, Zwisler AO, Borregaard B, Eilso JF, Sommer T, Tveskov C, Hendriks JM, Brandes A, Risom SS. Atrial fibrillation and primary care prevention and rehabilitation - a feasibility study. Pilot Feasibility Stud. 2025 Nov 26;11(1):150. doi: 10.1186/s40814-025-01724-3.

  PMID: 41299666 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible participants were diagnosed with AF at the hospital and had symptomatic AF rated by the modified European Heart Rhythm Association (mEHRA) score ≥2B. If the patient was eligible based on the mEHRA-score, at least one of the following risk factors had to be present: hypertension, diabetes, obesity, smoking, excessive alcohol consumption, physical inactivity, sleep apnoea, anxiety, depression, or mental vulnerability.

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 29, 2024
• Study Start: February 1, 2019
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: March 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)