A Precision Medicine Approach to the Prevention of Depression in Patients With Atrial Fibrillation (NCT07178691) | Clinical Trial Compass
CompletedNot Applicable
A Precision Medicine Approach to the Prevention of Depression in Patients With Atrial Fibrillation
Denmark28 participantsStarted 2024-04-19
Plain-language summary
The purpose of the proposed project is to test a new therapist-assisted, eHealth intervention (HOPE-AF) targeted to prevent depression in patients with atrial fibrillation (AF). AF is the most common sustained cardiac arrhythmia. Age is the most common risk factor for AF, and given the ageing of the population, the prevalence of AF has increased threefold during the last 50 years. AF is now considered a major public health challenge. AF is not only associated with increased risk of stroke and heart failure but patients with AF also tend to continuously focus on the body's signals and have difficulties accepting the disease. This is often paired with psychological reactions, such as excessive worry and anxiety, increasing the risk of withdrawal from social activities, which often leads to depression. Patients with AF and comorbid depression are at greater risk of a poor prognosis.
The project is a feasibility study to examine acceptability, adherence and limited efficacy, as well as barriers and facilitators for implementation of the intervention in clinical practice. The project is multi-disciplinary and embedded within the rehabilitation setting in the hospitals, enhancing the chance of later implementation.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥18 years
* Diagnosis of paroxysmal or persistent AF \[if persistent AF, duration \< 2 years\]
* Able to use and access a computer or tablet/iPad to adhere to the intervention - Proficient in the Danish language (reading and writing)
* Ability to provide informed written consent.
Exclusion Criteria:
* Depression \[Hospital Anxiety and Depression Scale: HADS-D ≥11 (moderate symptoms)
* Anxiety \[Hospital Anxiety and Depression Scale: HADS-A ≥11 (moderate symptoms)
* Severe psychiatric or neurological disorder (e.g., schizophrenia or dementia)
* In need of psychiatric help due to comprehensive psychiatric issues, diagnosed or not
* Seeing a psychologist or mental health professional for the treatment of depression and anxiety
* Experiencing significant life stressors that hinder adherence to the HOPE-AF treatment
* Participating in another research project involving intervention for depression
* Not being able or willing to spend 1-2 hours on the intervention each week
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Drop out rate
Timeframe: From start of the intervention to completion of intervention, i.e., from 0 to 12 weeks.