Clinical trial NCT06337045: Atrial Fibrillation, Prevention and Rehabilitation
Official title: Atrial Fibrillation and Municipality-based Prevention and Rehabilitation - a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Prevention
Rehabilitation
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Department of Cardiology, Odense University Hospital, Odense, Denmark.
name: Health Center, Municipality of Svendborg, Svendborg, Denmark.
name: Department of Internal Medicine & Emergency Department, Svendborg Hospital, Odense University Hospital, Svendborg, Denmark.
name: The Danish Heart Association, Funen, and local committee in Svendborg, Denmark
First posted: 2024-03-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: HeartQoL
timeFrame: 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.
measure: The hospital anxiety and depression scale (HADS)
timeFrame: 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.
measure: Experience of participating, experiences needs and preferences of interventions
timeFrame: Focus group interviews was conducted at T1 (end of intervention, an average of 4 months).
measure: Feasibility of collecting patient reported outcomes (PROMs). The PROMs was the HeartQoL and the hospital anxiety and depression scale.
timeFrame: Field notes was collected at T2 (follow-up 2 months later).
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Department of Cardiology, Odense University Hospital
state: Region Of Southern Denmark
city: Svendborg
country: Denmark
facility: Health Center, Municipality Svendborg
state: Region Of Southern Denmark
Study officials:
References: