Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2019-02-01
2020-06-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Complex prevention and rehabilitation intervention (single arm)
It was a single-arm study.
Complex prevention and rehabilitation intervention
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.
Interventions
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Complex prevention and rehabilitation intervention
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.
Eligibility Criteria
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Inclusion Criteria
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 cardiac rehabilitation.
* dementia, mental illness, language barrier or comorbidity that made it impossible to participate in this study.
18 Years
ALL
No
Sponsors
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Department of Cardiology, Odense University Hospital, Odense, Denmark.
UNKNOWN
Health Center, Municipality of Svendborg, Svendborg, Denmark.
UNKNOWN
Department of Internal Medicine & Emergency Department, Svendborg Hospital, Odense University Hospital, Svendborg, Denmark.
UNKNOWN
The Danish Heart Association, Funen, and local committee in Svendborg, Denmark
UNKNOWN
Odense University Hospital
OTHER
Responsible Party
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Locations
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Department of Cardiology, Odense University Hospital
Odense, Region Syddanmark, Denmark
Health Center, Municipality Svendborg
Svendborg, Region Syddanmark, Denmark
Countries
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Other Identifiers
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AF-rehab
Identifier Type: -
Identifier Source: org_study_id
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