Atrial FibrillationNCT06337045
Atrial Fibrillation, Prevention and Rehabilitation
A study testing Complex prevention and rehabilitation intervention in people with Atrial Fibrillation and Prevention, run by Odense University Hospital at 2 sites in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Prevention, Rehabilitation
- What is being tested?
- Complex prevention and rehabilitation intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Feb 2019to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Department of Cardiology, Odense University Hospital
Odense, Region Syddanmark, 5000
Health Center, Municipality Svendborg
Svendborg, Region Syddanmark, 5700
About this study
Official title: Atrial Fibrillation and Municipality-based Prevention and Rehabilitation - a Feasibility Study
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.
Read more
There were the following four secondary objectives:
- To explore the participant's experiences of participating in the municipality-based complex prevention and rehabilitation intervention.
- To explore the participant's needs and preferences of the interventions.
- To explore changes in HRQoL, anxiety and depression.
- 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.
- Conditions
- Atrial Fibrillation, Prevention, Rehabilitation
- Being tested
- Complex prevention and rehabilitation intervention
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complex prevention and rehabilitation interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Complex prevention and rehabilitation intervention (single arm) | Experimental | It was a single-arm study. Receives: Behavioral: Complex prevention and rehabilitation intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Field notes was collected at T2 (follow-up 2 months later).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start1 Feb 2019
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Cardiology, Odense University Hospital, Odense, Denmark., Health Center, Municipality of Svendborg, Svendborg, Denmark., Department of Internal Medicine & Emergency Department, Svendborg Hospital, Odense University Hospital, Svendborg, Denmark., The Danish Heart Association, Funen, and local committee in Svendborg, Denmark
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06337045
- Sponsor's protocol ID
- AF-rehab
- Status last verified
- Mar 2024
- First submitted
- 27 Feb 2024
- Last updated
- 29 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41299666
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Fibrillation and Municipality-based Prevention and Rehabilitation - a Feasibility Study
- ClinicalTrials.gov ID
- NCT06337045
- Acronym / sponsor ID
- AF-rehab
- Conditions
- Atrial Fibrillation, Prevention, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Department of Cardiology, Odense University Hospital, Odense, Denmark., Health Center, Municipality of Svendborg, Svendborg, Denmark., Department of Internal Medicine & Emergency Department, Svendborg Hospital, Odense University Hospital, Svendborg, Denmark., The Danish Heart Association, Funen, and local committee in Svendborg, Denmark
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 29 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To explore the participant's experiences of participating in the municipality-based complex prevention and rehabilitation intervention.
- To explore the participant's needs and preferences of the interventions.
- To explore changes in HRQoL, anxiety and depression.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Complex prevention and rehabilitation intervention (single arm) | Experimental | Behavioral: Complex prevention and rehabilitation interventionIt was a single-arm study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- the modified European Heart Rhythm Association (mEHRA) score ≥2B.
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complex prevention and rehabilitation interventionThe 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. | Behavioural | Complex prevention and rehabilitation intervention (single arm) |
Primary outcome
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.
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).
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Derived from this study: PubMed 41299666Elnegaard 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.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complex prevention and rehabilitation intervention in people with Atrial Fibrillation and Prevention, run by Odense University Hospital at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06337045, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2024.