Evaluatie van YouControl-AFib, een mHealth-applicatie voor personen met boezemfibrilleren
Implementatie van de YouControl-AFib mHealth-applicatie (pilotversie) om de fysieke activiteit bij personen met atriumfibrilleren te verbeteren
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Wisconsin
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Madison, Wisconsin, Verenigde Staten, 53792
- UW School of Medicine and Public Health
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Mensen die de YouControl-A-Fib-app gebruiken
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Participants will use the app for 3 months, includes 1 month phone call with Health Coach |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Average Number of Participants Recruited Per Month
Tijdsspanne: up to 6 months
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up to 6 months
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Maximum Number of Participants Recruited in a Single Month
Tijdsspanne: up to 6 months
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up to 6 months
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Mobile App Rating Scale Score
Tijdsspanne: 3 months
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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. |
3 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in 6-minute Walk Distance (Compared to Baseline for Each Participant) After Using the mHealth App for 3 Months
Tijdsspanne: baseline, 3 months
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baseline, 3 months
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Weekly Step Count After Using the mHealth App for Three Months
Tijdsspanne: week 1, week 12
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week 1, week 12
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Intentional Activity Time (in One Week) After Using the mHealth App for Three Months
Tijdsspanne: week 1, week 12
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week 1, week 12
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General Quality of Life Questionnaire: SF-12 Physical Component Summary Score
Tijdsspanne: baseline, 3 months
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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. |
baseline, 3 months
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General Quality of Life Questionnaire: SF-12 Mental Component Summary Score
Tijdsspanne: baseline, 3 months
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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. |
baseline, 3 months
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Patient Health Questionnaire (PHQ-9) Score
Tijdsspanne: baseline, 3 months
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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. |
baseline, 3 months
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Change in Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT) Score
Tijdsspanne: baseline, 3 months
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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. |
baseline, 3 months
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Atrial Fibrillation Symptom Severity (AFSS) Score
Tijdsspanne: baseline, 3 months
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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. |
baseline, 3 months
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Percent Correct on the Atrial Fibrillation Knowledge Assessment Tool (AFKAT)
Tijdsspanne: baseline, 3 months
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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. |
baseline, 3 months
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Life's Essential 8 Score After Using the mHealth App for Three Months
Tijdsspanne: baseline, 3 months
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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. |
baseline, 3 months
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Irregular Heart Rate Notifications (in One Week) After Using the mHealth App for Three Months
Tijdsspanne: baseline, 3 months
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baseline, 3 months
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in ECG-age After Using the mHealth App for Three Months
Tijdsspanne: baseline, 3 months
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Participants will obtain single-lead ECGs at baseline and after three months. The time-voltage data are run through an ECG-AI model for estimating ECG-age. ECG-age is a novel metric developed by investigators at Wake Forest. See reference section for relevant publication describing a similar model. Summary results will be reported as ECG-age in years. |
baseline, 3 months
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Matthew M Kalscheur, MD, UW School of Medicine and Public Health
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2024-0954
- A534225 (Andere identificatie: UW Madison)
- Protocol Version 8/6/2024 (Andere identificatie: UW Madison)
- 1UL1TR002373 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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.
IPD-tijdsbestek voor delen
Data from this study may be requested from other researchers 7 years after the completion of the primary endpoint by contacting the PI.
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- ICF
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
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