Atrial FibrillationEMPOWER-AFNCT07498283
Peer-Mentor Support for Vulnerable Patients With Atrial Fibrillation
A study testing Peer-Mentor Support in people with Atrial Fibrillation, run by University College Copenhagen at 3 sites in Denmark.
Trial summary
The goal of this randomized clinical trial is to evaluate whether a peer-mentor intervention can improve mental well-being among vulnerable patients with atrial fibrillation (AF). Patients with AF often experience anxiety, uncertainty, and reduced quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Peer-Mentor Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 3 sitesDenmark
- Study dates
- 26 May 2026to 1 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adults (≥18 years) with a confirmed diagnosis of atrial fibrillation
- Low socioeconomic position, primarily defined as educational attainment of vocational education or below
- Able to understand and speak Danish
- Able to provide written informed consent
- Able to complete study questionnaires
Who cannot join
- Inability to provide informed consent
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark3 sites, 3 recruiting
- Recruiting
Herlev and Gentofte Hospital
Herlev, Capital Region, 2730
Cecilie M L Mielow, MScN, +4523474229, cecilie.mia.lykke.mielow.01@regionh.dk
Cecilie M L Mielow, MScNS
- Recruiting
Nordsjealland Hospital
Hillerød, Capital Region, 3400
Cecilie M L Mielow, MScNS, +4523474229, cecilie.mia.lykke.mielow.01@regionh.dk
Maria K Pedersern, PhD, maria.kjoeller.pedersen@regionh.dk
- Not yet recruiting
Amager and Hvidovre Hospital
Hvidovre, Capital Region, 2650
Cecilie M L Mielow, MScN, +4523474229, cecilie.mia.lykke.mielow.01@regionh.dk
Stine M Rosenstroem, PhD, stine.maria.rosenstroem@regionh.dk
About this study
Official title: Explore and Improve Mental Well-being Among Vulnerable Patients With Atrial Fibrillation - A Randomized Controlled Trial of a Peer-Mentor Intervention
The goal of this randomized clinical trial is to evaluate whether a peer-mentor intervention can improve mental well-being among vulnerable patients with atrial fibrillation (AF). Patients with AF often experience anxiety, uncertainty, and reduced quality of life. These challenges are particularly pronounced among individuals with low socioeconomic position, who may face additional barriers to accessing supportive care.
The main question the study aims to answer is:
Read more
Does a 16-week peer-mentor intervention reduce anxiety symptoms among patients with AF compared with usual care?
Researchers will compare peer-mentor support plus usual care with usual care alone.
Participants will:
Complete questionnaires about anxiety, depressive symptoms, quality of life, and self-efficacy at baseline and after 16 weeks.
Be randomized either to receive peer-mentor support for 16 weeks or to receive usual care only.
If allocated to the intervention group, be matched with a trained peer mentor with lived experience of atrial fibrillation who provides emotional support and practical guidance through approximately eight contacts over the 16-week period.
The study will also include follow-up using national health registers and a mixed-methods process evaluation exploring participants' and mentors' experiences with the intervention.
Read the detailed description
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and is associated with significant symptom burden, reduced quality of life, and high levels of psychological distress. Anxiety is particularly prevalent among patients with AF and may worsen symptom perception, increase health-related worry, and negatively affect engagement in self-management and healthcare. Individuals with low socioeconomic position often experience greater disease burden and face additional barriers to accessing supportive care, contributing to social inequalities in cardiovascular health.
Peer support interventions have shown promising effects in other cardiac populations by providing emotional support, normalization of illness experiences, and practical guidance based on lived experience. Such interventions may enhance patients' confidence in managing their condition and navigating everyday life with chronic illness.
The EMPOWER-AF study aims to evaluate the effectiveness of a peer-mentor intervention designed to support vulnerable patients with AF. The intervention is grounded in social cognitive theory, particularly the concept of self-efficacy, and is intended to strengthen patients' ability to manage symptoms, cope with uncertainty, and improve mental well-being.
The study is conducted as a randomized controlled trial with two parallel groups. Participants are randomized to either a peer-mentor intervention in addition to usual care or usual care alone. The intervention lasts 16 weeks and involves one-to-one support between a trained peer mentor and a patient with AF. Peer mentors are individuals with lived experience of AF who have achieved stable everyday management of the condition and who are trained to provide emotional support and experiential guidance. Contacts between mentors and mentees may take place via telephone, face-to-face meetings, or digital communication depending on participant preferences.
In addition to the randomized trial, the study includes an embedded mixed-methods process evaluation to explore participants' and mentors' experiences, mechanisms of impact, and contextual factors influencing engagement with the intervention.
The study seeks to generate evidence on whether peer-based support can improve mental well-being among vulnerable patients with AF and contribute to more equitable and person-centered care for this patient group.
- Conditions
- Atrial Fibrillation
- Being tested
- Peer-Mentor Support
- Keywords
- Peer mentor support, Mental well-being, Anxiety, Self-efficacy, Socioeconomic vulnerability, Atrial fibrillation, Cardiac patients
- Medical subject headings
- Atrial Fibrillation, Psychological Well-Being, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer-Mentor SupportBehavioural
A 16-week peer-mentor program designed to support patients living with atrial fibrillation. Participants are matched with trained peer mentors who have lived experience with atrial fibrillation. Mentors provide emotional support, normalization of illness experiences, and practical non-clinical guidance for managing everyday life with the condition. Contacts between mentors and participants are planned approximately eight times during the intervention period and may take place via telephone, face-to-face meetings, or digital communication according to participant preferences. Mentors do not provide medical advice.
| Study group | Role | What they receive |
|---|---|---|
| Peer-Mentor Support + Usual Care | Experimental | Participants randomized to this arm receive a 16-week peer-mentor intervention in addition to usual care. Each participant is matched with a trained peer mentor with lived experience of atrial fibrillation who provides emotional support, normalization of illness experiences, and practical guidance. The intervention includes approximately eight contacts over 16 weeks delivered via telephone, face-to-face meetings, or digital communication depending on participant preferences. Participants continue to receive usual medical care throughout the study period. Receives: Behavioral: Peer-Mentor Support |
| Usual care | No intervention | Participants randomized to this arm receive usual care according to local clinical practice for atrial fibrillation. No peer-mentor support is provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety symptoms measured by the Hospital Anxiety and Depression Scale (HADS-A)
Anxiety symptoms are assessed using the Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A). The subscale consists of 7 items assessing symptoms such as tension, worry, and panic, each scored from 0 to 3. The total score ranges from 0 to 21, with higher scores indicating greater levels of anxiety symptoms.
Measured: Baseline and 16 weeks
Secondary outcomes (7)
Depressive symptoms measured by the Hospital Anxiety and Depression Scale (HADS-D)
Depressive symptoms are assessed using the Hospital Anxiety and Depression Scale - Depression subscale (HADS-D). The subscale consists of 7 items assessing mood, interest, and enjoyment, each scored from 0 to 3. The total score ranges from 0 to 21, with higher scores indicating greater levels of depressive symptoms.
Measured: Baseline and 16 weeks
Atrial fibrillation-specific quality of life measured by the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT)
Quality of life is assessed using the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire. The questionnaire includes items assessing symptoms, daily activities, treatment concerns, and satisfaction over the past 4 weeks. Items are rated on a 7-point scale, and scores are transformed to a scale from 0 to 100, with higher scores indicating better quality of life.
Measured: Baseline and 16 weeks
Self-efficacy measured by the Self-Efficacy for Managing Chronic Disease scale (SES6G)
Self-efficacy is assessed using the Self-Efficacy for Managing Chronic Disease scale (SES6G), which includes 6 items assessing confidence in managing symptoms, emotional challenges, and daily activities related to chronic illness. Each item is scored on a scale from 1 to 10, and the total score is calculated as the mean of the items, with higher scores indicating greater self-efficacy.
Measured: Baseline and 16 weeks
Use of antidepressants and benzodiazepines based on redeemed prescriptions
Use of psychotropic medication is assessed using national prescription register data. This includes antidepressants (ATC code N06A) and benzodiazepines (ATC code N05B). The outcome is defined as the occurrence of at least one redeemed prescription during follow-up.Outcome assessments are conducted at 24 weeks and 1 year after completion of the 16-week intervention.
Measured: From randomization to 24 weeks and 1 year follow-up
Diagnoses of anxiety and depression based on hospital records
Diagnoses of anxiety and depression are assessed using national patient register data. Diagnoses include anxiety disorders (ICD-10 code F41*) and depressive disorders (ICD-10 codes F32-F33*). The outcome is defined as the occurrence of at least one diagnosis during follow-up. Outcome assessments are conducted at 24 weeks and 1 year after completion of the 16-week intervention.
Measured: From randomization to 24 weeks and 1 year follow-up
Atrial fibrillation-related hospital contacts
Hospital contacts related to atrial fibrillation are assessed using national patient register data. Contacts are identified using ICD-10 code I48* and include inpatient admissions and outpatient visits. The outcome is defined as the occurrence of at least one AF-related hospital contact during follow-up. Outcome assessments are conducted at 24 weeks and 1 year after completion of the 16-week intervention.
Measured: From randomization to 24 weeks and 1 year follow-up
Cardiac death and suicide
Mortality outcomes are assessed using national register data and include cardiac death and suicide during follow-up. The outcome is defined as the occurrence of death during the follow-up period. Outcome assessments are conducted at 24 weeks and 1 year after completion of the 16-week intervention.
Measured: From randomization to 24 weeks and 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start26 May 2026
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm parallel-group randomized controlled trial comparing a peer-mentor intervention plus usual care with usual care alone.
- Masking
- None (open label)
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Herlev and Gentofte Hospital, Nordsjaellands Hospital, Hvidovre University Hospital, Amager Hospital
- Responsible party
- Principal investigator, Cecilie Mia Lykke Mielow, University College Copenhagen
- Investigators
- Signe S Risom, Senior Researcher, Principal investigator, Herlev and Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07498283
- Sponsor's protocol ID
- F-26003029
- Acronym
- EMPOWER-AF
- Status last verified
- Jan 2026
- First submitted
- 17 Mar 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explore and Improve Mental Well-being Among Vulnerable Patients With Atrial Fibrillation - A Randomized Controlled Trial of a Peer-Mentor Intervention
- ClinicalTrials.gov ID
- NCT07498283
- Acronym / sponsor ID
- EMPOWER-AF / F-26003029
- Conditions
- Atrial Fibrillation
- Keywords
- Peer mentor support, Mental well-being, Anxiety, Self-efficacy, Socioeconomic vulnerability, Atrial fibrillation, Cardiac patients
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- University College CopenhagenUniversity, hospital or other
- Collaborators
- Herlev and Gentofte Hospital, Nordsjaellands Hospital, Hvidovre University Hospital, Amager Hospital
- Study start
- 26 May 2026 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 27 Mar 2026 (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.
The goal of this randomized clinical trial is to evaluate whether a peer-mentor intervention can improve mental well-being among vulnerable patients with atrial fibrillation (AF). Patients with AF often experience anxiety, uncertainty, and reduced quality of life. These challenges are particularly pronounced among individuals with low socioeconomic position, who may face additional barriers to accessing supportive care.
The main question the study aims to answer is:
Does a 16-week peer-mentor intervention reduce anxiety symptoms among patients with AF compared with usual care?
Researchers will compare peer-mentor support plus usual care with usual care alone.
Participants will:
Complete questionnaires about anxiety, depressive symptoms, quality of life, and self-efficacy at baseline and after 16 weeks.
Be randomized either to receive peer-mentor support for 16 weeks or to receive usual care only.
If allocated to the intervention group, be matched with a trained peer mentor with lived experience of atrial fibrillation who provides emotional support and practical guidance through approximately eight contacts over the 16-week period.
The study will also include follow-up using national health registers and a mixed-methods process evaluation exploring participants' and mentors' experiences with the intervention.
Detailed description
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and is associated with significant symptom burden, reduced quality of life, and high levels of psychological distress. Anxiety is particularly prevalent among patients with AF and may worsen symptom perception, increase health-related worry, and negatively affect engagement in self-management and healthcare. Individuals with low socioeconomic position often experience greater disease burden and face additional barriers to accessing supportive care, contributing to social inequalities in cardiovascular health.
Peer support interventions have shown promising effects in other cardiac populations by providing emotional support, normalization of illness experiences, and practical guidance based on lived experience. Such interventions may enhance patients' confidence in managing their condition and navigating everyday life with chronic illness.
The EMPOWER-AF study aims to evaluate the effectiveness of a peer-mentor intervention designed to support vulnerable patients with AF. The intervention is grounded in social cognitive theory, particularly the concept of self-efficacy, and is intended to strengthen patients' ability to manage symptoms, cope with uncertainty, and improve mental well-being.
The study is conducted as a randomized controlled trial with two parallel groups. Participants are randomized to either a peer-mentor intervention in addition to usual care or usual care alone. The intervention lasts 16 weeks and involves one-to-one support between a trained peer mentor and a patient with AF. Peer mentors are individuals with lived experience of AF who have achieved stable everyday management of the condition and who are trained to provide emotional support and experiential guidance. Contacts between mentors and mentees may take place via telephone, face-to-face meetings, or digital communication depending on participant preferences.
In addition to the randomized trial, the study includes an embedded mixed-methods process evaluation to explore participants' and mentors' experiences, mechanisms of impact, and contextual factors influencing engagement with the intervention.
The study seeks to generate evidence on whether peer-based support can improve mental well-being among vulnerable patients with AF and contribute to more equitable and person-centered care for this patient group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm parallel-group randomized controlled trial comparing a peer-mentor intervention plus usual care with usual care alone.
| Arm | Type | Receives |
|---|---|---|
| Peer-Mentor Support + Usual Care | Experimental | Behavioral: Peer-Mentor SupportParticipants randomized to this arm receive a 16-week peer-mentor intervention in addition to usual care. Each participant is matched with a trained peer mentor with lived experience of atrial fibrillation who provides emotional support, normalization of illness experiences, and practical guidance. The intervention includes approximately eight contacts over 16 weeks delivered via telephone, face-to-face meetings, or digital communication depending on participant preferences. Participants continue to receive usual medical care throughout the study period. |
| Usual care | No intervention | –Participants randomized to this arm receive usual care according to local clinical practice for atrial fibrillation. No peer-mentor support is provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults (≥18 years) with a confirmed diagnosis of atrial fibrillation
- Low socioeconomic position, primarily defined as educational attainment of vocational education or below
- Able to understand and speak Danish
- Able to provide written informed consent
- Able to complete study questionnaires
Key exclusion criteria (1 listed)
- Inability to provide informed consent
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 |
|---|---|---|
| Peer-Mentor SupportA 16-week peer-mentor program designed to support patients living with atrial fibrillation. Participants are matched with trained peer mentors who have lived experience with atrial fibrillation. Mentors provide emotional support, normalization of illness experiences, and practical non-clinical guidance for managing everyday life with the condition. Contacts between mentors and participants are planned approximately eight times during the intervention period and may take place via telephone, face-to-face meetings, or digital communication according to participant preferences. Mentors do not provide medical advice. | Behavioural | Peer-Mentor Support + Usual Care |
Primary outcome
Anxiety symptoms measured by the Hospital Anxiety and Depression Scale (HADS-A)
Time frame: Baseline and 16 weeks
Anxiety symptoms are assessed using the Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A). The subscale consists of 7 items assessing symptoms such as tension, worry, and panic, each scored from 0 to 3. The total score ranges from 0 to 21, with higher scores indicating greater levels of anxiety symptoms.
7 secondary outcomes
Depressive symptoms measured by the Hospital Anxiety and Depression Scale (HADS-D)
Time frame: Baseline and 16 weeks
Atrial fibrillation-specific quality of life measured by the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT)
Time frame: Baseline and 16 weeks
Self-efficacy measured by the Self-Efficacy for Managing Chronic Disease scale (SES6G)
Time frame: Baseline and 16 weeks
Use of antidepressants and benzodiazepines based on redeemed prescriptions
Time frame: From randomization to 24 weeks and 1 year follow-up
Diagnoses of anxiety and depression based on hospital records
Time frame: From randomization to 24 weeks and 1 year follow-up
Atrial fibrillation-related hospital contacts
Time frame: From randomization to 24 weeks and 1 year follow-up
Cardiac death and suicide
Time frame: From randomization to 24 weeks and 1 year follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
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.
Signe S Risom, Senior Researcher principal investigator
Herlev and Gentofte Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer-Mentor Support in people with Atrial Fibrillation, run by University College Copenhagen at 3 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 5 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cecilie M L Mielow, MScN (+4523474229, cecilie.mia.lykke.mielow.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety symptoms measured by the Hospital Anxiety and Depression Scale (HADS-A) (time frame: Baseline and 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2026.