Utvärdering av YouControl-AFib, en mHealth-applikation för personer med förmaksflimmer
Implementering av YouControl-AFib mHealth Application (pilotversion) för att förbättra fysisk aktivitet hos personer med förmaksflimmer
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Wisconsin
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Madison, Wisconsin, Förenta staterna, 53792
- UW School of Medicine and Public Health
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Personer som använder YouControl-A-Fib-appen
|
Participants will use the app for 3 months, includes 1 month phone call with Health Coach |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Average Number of Participants Recruited Per Month
Tidsram: up to 6 months
|
up to 6 months
|
|
|
Maximum Number of Participants Recruited in a Single Month
Tidsram: up to 6 months
|
up to 6 months
|
|
|
Mobile App Rating Scale Score
Tidsram: 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. |
3 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in 6-minute Walk Distance (Compared to Baseline for Each Participant) After Using the mHealth App for 3 Months
Tidsram: baseline, 3 months
|
baseline, 3 months
|
|
|
Weekly Step Count After Using the mHealth App for Three Months
Tidsram: week 1, week 12
|
week 1, week 12
|
|
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Intentional Activity Time (in One Week) After Using the mHealth App for Three Months
Tidsram: week 1, week 12
|
week 1, week 12
|
|
|
General Quality of Life Questionnaire: SF-12 Physical Component Summary Score
Tidsram: baseline, 3 months
|
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
|
|
General Quality of Life Questionnaire: SF-12 Mental Component Summary Score
Tidsram: baseline, 3 months
|
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
|
|
Patient Health Questionnaire (PHQ-9) Score
Tidsram: baseline, 3 months
|
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
|
|
Change in Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT) Score
Tidsram: baseline, 3 months
|
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
|
|
Atrial Fibrillation Symptom Severity (AFSS) Score
Tidsram: baseline, 3 months
|
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
|
|
Percent Correct on the Atrial Fibrillation Knowledge Assessment Tool (AFKAT)
Tidsram: baseline, 3 months
|
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
|
|
Life's Essential 8 Score After Using the mHealth App for Three Months
Tidsram: baseline, 3 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. |
baseline, 3 months
|
|
Irregular Heart Rate Notifications (in One Week) After Using the mHealth App for Three Months
Tidsram: baseline, 3 months
|
baseline, 3 months
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in ECG-age After Using the mHealth App for Three Months
Tidsram: baseline, 3 months
|
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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Matthew M Kalscheur, MD, UW School of Medicine and Public Health
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2024-0954
- A534225 (Annan identifierare: UW Madison)
- Protocol Version 8/6/2024 (Annan identifierare: UW Madison)
- 1UL1TR002373 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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.
Tidsram för IPD-delning
Data from this study may be requested from other researchers 7 years after the completion of the primary endpoint by contacting the PI.
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ICF
Läkemedels- och apparatinformation, studiedokument
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