Atrial FibrillationNCT06575348
Evaluation of YouControl-AFib, a mHealth Application for Persons With Atrial Fibrillation
A study of Atrial Fibrillation, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This study is being done to establish the feasibility of performing a clinical trial using a mHealth application named YouControl-AFib designed to improve the cardiovascular health of persons with atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2024to 22 Jul 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand and the willingness to sign a written informed consent document
- Willing to comply with all study procedures and be available for the duration of the study
- SmartPhone capable of pairing with a Fitbit Sense 2 and Fitbit App (Apple iOS 15 and higher or Android 10 or higher)
- Paroxysmal or persistent atrial fibrillation verified by 12-lead electrocardiogram (ECG) or other clinical grade monitoring
- body mass index (BMI) greater than 27
Who cannot join
- History of permanent atrial fibrillation
- Left ventricular ejection fraction (LVEF) less than 45 percent
- Myocardial infarction, coronary artery bypass grafting, or valve surgery within the last 12 months
- Moderate to severe valve disease
- Inability to participate in a structured exercise program due to musculoskeletal disease
- Already participating in a structured exercise program or achieving guideline directed physical activity
- Planned surgery or procedure during the next three months that limit ability to engage in physical activity
Trial locations and contacts
1 site in 1 country.
United States1 site
UW School of Medicine and Public Health
Madison, Wisconsin, 53792
About this study
Official title: Implementation of the YouControl-AFib mHealth Application (Pilot Version) to Improve Physical Activity in Persons With Atrial Fibrillation
This study is being done to establish the feasibility of performing a clinical trial using a mHealth application named YouControl-AFib designed to improve the cardiovascular health of persons with atrial fibrillation. The study will obtain feedback on the app design to inform future versions and will collect preliminary data to support proof-of-concept and potential effect sizes for future trial design.
Read the detailed description
Primary Objective
- To effectively recruit participants for a clinical trial and obtain user feedback on the mHealth app using the Mobile App Rating Scale and focus group sessions.
Secondary Objectives
- To evaluate the impact of the YouControl-AFib mHealth app (pilot version, 3 months of use) on physical activity in persons with atrial fibrillation.
- To obtain several additional functional and disease specific endpoints that will help establish possible effect sizes to be evaluated more formally in subsequent versions of the mHealth application.
- To obtain user feedback on the mHealth app using the Mobile App Rating Scale and focus group sessions.
- Conditions
- Atrial Fibrillation
- Being tested
- YouControl-A-Fib mHealth Application
- Keywords
- physical exercise, application, supportive care
- Medical subject headings
- Atrial Fibrillation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YouControl-A-Fib mHealth ApplicationDevice
Participants will use the app for 3 months, includes 1 month phone call with Health Coach
| Study group | Role | What they receive |
|---|---|---|
| People using YouControl-A-Fib app | Experimental | Not described Receives: Device: YouControl-A-Fib mHealth Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Number of Participants Recruited Per Month
Measured: up to 6 months
Maximum Number of Participants Recruited in a Single Month
Measured: up to 6 months
Mobile App Rating Scale Score
Mobile App Rating Scale contains several subscales that will each be scored on a scale of 1-5; B-functionality, C-aesthetics, and D-information. Higher scores indicate high levels of functionality, aesthetics, and information quality. The overall mean score for all sub-scales is reported here.
Measured: 3 months
Secondary outcomes (11)
Change in 6-minute Walk Distance (Compared to Baseline for Each Participant) After Using the mHealth App for 3 Months
Measured: baseline, 3 months
Weekly Step Count After Using the mHealth App for Three Months
Measured: week 1, week 12
Intentional Activity Time (in One Week) After Using the mHealth App for Three Months
Measured: week 1, week 12
General Quality of Life Questionnaire: SF-12 Physical Component Summary Score
SF-12 measures the impact of health on the participant's life and is scored from 0-100 where higher scores indicates higher health related quality of life.
Measured: baseline, 3 months
General Quality of Life Questionnaire: SF-12 Mental Component Summary Score
SF-12 measures the impact of health on the participant's life and is scored from 0-100 where higher scores indicates higher health related quality of life.
Measured: baseline, 3 months
Patient Health Questionnaire (PHQ-9) Score
PHQ-9 is a 9-item questionnaire scored on a 4 point likert scale from 0-3 for a total possible range of scores from 0-27. Higher scores indicate increased depression.
Measured: baseline, 3 months
Change in Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT) Score
AFEQT is a 20-item survey scored on a 7 point likert scale from 1-7 (total possible range of scores is converted to be from 0-100) where higher scores indicate higher effect that atrial fibrillation has on the participant's quality of life.
Measured: baseline, 3 months
Atrial Fibrillation Symptom Severity (AFSS) Score
AFSS is a 7-item survey scored on a likert scale from 0-5 for a total possible range of scores from 0-35 where higher scores indicate greater symptom severity.
Measured: baseline, 3 months
Percent Correct on the Atrial Fibrillation Knowledge Assessment Tool (AFKAT)
AFKAT is a 21-item true / false assessment that measures knowledge about atrial fibrillation. Correct answers are scored with a 1 for a total possible range of scores from 0-21. Higher scores indicate increased knowledge of atrial fibrillation. Reported here is the percent correct.
Measured: baseline, 3 months
Life's Essential 8 Score After Using the mHealth App for Three Months
Life's Essential 8 score (LE8) is a composite score between 0-100 that assesses a participant's adherence to 8 lifestyle recommendations with improve cardiovascular health: diet, physical activity, smoking habits, body mass index, cholesterol, blood glucose, and sleep duration. Higher scores are indicative of higher adherence to healthy lifestyle.
Measured: baseline, 3 months
Irregular Heart Rate Notifications (in One Week) After Using the mHealth App for Three Months
Measured: baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start17 Oct 2024
- Primary completion22 Jul 2025
- Study completion22 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Matthew M Kalscheur, MD, Principal investigator, UW School of Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06575348
- Sponsor's protocol ID
- 2024-0954
- Other IDs
- A534225, Protocol Version 8/6/2024, 1UL1TR002373
- Status last verified
- Sep 2026
- First submitted
- 22 Aug 2024
- Last updated
- 25 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be submitted to ClinicalTrials.gov. Every attempt will be made to publish results in peer-reviewed journals.
Publications
Attia ZI, Friedman PA, Noseworthy PA, Lopez-Jimenez F, Ladewig DJ, Satam G, Pellikka PA, Munger TM, Asirvatham SJ, Scott CG, Carter RE, Kapa S. Age and Sex Estimation Using Artificial Intelligence From Standard 12-Lead ECGs. Circ Arrhythm Electrophysiol. 2019 Sep;12(9):e007284. doi: 10.1161/CIRCEP.119.007284. Epub 2019 Aug 27.
PubMed 31450977
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of the YouControl-AFib mHealth Application (Pilot Version) to Improve Physical Activity in Persons With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT06575348
- Acronym / sponsor ID
- 2024-0954
- Conditions
- Atrial Fibrillation
- Keywords
- physical exercise, application, supportive care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 17 Oct 2024 (actual)
- Primary completion
- 22 Jul 2025 (actual)
- Study completion
- 22 Jul 2025 (actual)
- First posted
- 28 Aug 2024 (actual)
- Results
- Posted 25 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to establish the feasibility of performing a clinical trial using a mHealth application named YouControl-AFib designed to improve the cardiovascular health of persons with atrial fibrillation. The study will obtain feedback on the app design to inform future versions and will collect preliminary data to support proof-of-concept and potential effect sizes for future trial design.
Detailed description
Primary Objective
- To effectively recruit participants for a clinical trial and obtain user feedback on the mHealth app using the Mobile App Rating Scale and focus group sessions.
Secondary Objectives
- To evaluate the impact of the YouControl-AFib mHealth app (pilot version, 3 months of use) on physical activity in persons with atrial fibrillation.
- To obtain several additional functional and disease specific endpoints that will help establish possible effect sizes to be evaluated more formally in subsequent versions of the mHealth application.
- To obtain user feedback on the mHealth app using the Mobile App Rating Scale and focus group sessions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People using YouControl-A-Fib app | Experimental | Device: YouControl-A-Fib mHealth Application |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ability to understand and the willingness to sign a written informed consent document
- Willing to comply with all study procedures and be available for the duration of the study
- SmartPhone capable of pairing with a Fitbit Sense 2 and Fitbit App (Apple iOS 15 and higher or Android 10 or higher)
- Paroxysmal or persistent atrial fibrillation verified by 12-lead electrocardiogram (ECG) or other clinical grade monitoring
- body mass index (BMI) greater than 27
Key exclusion criteria (7 listed)
- History of permanent atrial fibrillation
- Left ventricular ejection fraction (LVEF) less than 45 percent
- Myocardial infarction, coronary artery bypass grafting, or valve surgery within the last 12 months
- Moderate to severe valve disease
- Inability to participate in a structured exercise program due to musculoskeletal disease
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 |
|---|---|---|
| YouControl-A-Fib mHealth ApplicationParticipants will use the app for 3 months, includes 1 month phone call with Health Coach | Device | People using YouControl-A-Fib app |
Primary outcome
Average Number of Participants Recruited Per Month
Time frame: up to 6 months
Maximum Number of Participants Recruited in a Single Month
Time frame: up to 6 months
Mobile App Rating Scale Score
Time frame: 3 months
Mobile App Rating Scale contains several subscales that will each be scored on a scale of 1-5; B-functionality, C-aesthetics, and D-information. Higher scores indicate high levels of functionality, aesthetics, and information quality. The overall mean score for all sub-scales is reported here.
11 secondary outcomes
Change in 6-minute Walk Distance (Compared to Baseline for Each Participant) After Using the mHealth App for 3 Months
Time frame: baseline, 3 months
Weekly Step Count After Using the mHealth App for Three Months
Time frame: week 1, week 12
Intentional Activity Time (in One Week) After Using the mHealth App for Three Months
Time frame: week 1, week 12
General Quality of Life Questionnaire: SF-12 Physical Component Summary Score
Time frame: baseline, 3 months
General Quality of Life Questionnaire: SF-12 Mental Component Summary Score
Time frame: baseline, 3 months
Patient Health Questionnaire (PHQ-9) Score
Time frame: baseline, 3 months
Change in Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT) Score
Time frame: baseline, 3 months
Atrial Fibrillation Symptom Severity (AFSS) Score
Time frame: baseline, 3 months
Percent Correct on the Atrial Fibrillation Knowledge Assessment Tool (AFKAT)
Time frame: baseline, 3 months
Life's Essential 8 Score After Using the mHealth App for Three Months
Time frame: baseline, 3 months
Irregular Heart Rate Notifications (in One Week) After Using the mHealth App for Three Months
Time frame: baseline, 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31450977Attia ZI, Friedman PA, Noseworthy PA, Lopez-Jimenez F, Ladewig DJ, Satam G, Pellikka PA, Munger TM, Asirvatham SJ, Scott CG, Carter RE, Kapa S. Age and Sex Estimation Using Artificial Intelligence From Standard 12-Lead ECGs. Circ Arrhythm Electrophysiol. 2019 Sep;12(9):e007284. doi: 10.1161/CIRCEP.119.007284. Epub 2019 Aug 27.
- Individual participant dataSharing planned: Yes. This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be submitted to ClinicalTrials.gov. Every attempt will be made to publish results in peer-reviewed journals.
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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.
Matthew M Kalscheur, MD principal investigator
UW School of Medicine and Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Atrial Fibrillation, run by University of Wisconsin, Madison at 1 site in United States.
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 7 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 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 25 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Average Number of Participants Recruited Per Month (time frame: up to 6 months). The study lists 3 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 NCT06575348, 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 25 Sep 2026.