Investigating Behavior Change Methods for the Management of Hypertension
This project aims to promote general wellness using a mobile health intervention that incorporates health coaching to help manage hypertension. The mobile application (HyperCoach) does not intend to cure, mitigate, or prevent hypertension. The main questions it aims to answer are:
- Does digital mobile health coaching impact hypertension management outcomes, including blood pressure and adherence?
- How does adherence to mobile health intervention influence the long-term man-agement and outcomes of hypertension?
- How are health beliefs and QOL affected by digital coaching and health tracking for hypertension management?
Participants will be required to complete the following:
Blood pressure reading every day Weight reading every day Take hypertension medication as prescribed by their physician Complete educational content (if on coaching group) Belief and Attitudes Survey (before and after study) Personality Assessment Survey Demographic Information Survey Hypertension Health Literacy Survey (before and after study) Two General Health Literacy Surveys (before and after study) Quality of Life Survey
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Background: Hypertension has become one of the most common conditions in the world. Approximately 1.28 billion people suffer from this ailment. Change is required in the world of today to adopt more health-conscious practices to avoid further growth of the population suffering from this affliction.
Objective: This project aims to promote general wellness using a mobile health intervention that incorporates health coaching to help manage hypertension. The mobile application (HyperCoach) does not intend to cure, mitigate, or prevent hypertension.
Health coaching is a method designed to guide participants in attaining their health goals through active intervention providing them with educational content, reminders, goal-setting capabilities, and feedback. The educational content will be conducted by introducing the participant to the process of performing their body measurements properly (blood pressure and weight) and then through training through our designed phone application. Reminders will be sent if the participant has yet to complete their assigned tasks of the day.
At the beginning of the study, participants will have the opportunity to establish their own personal health goals for blood pressure, resting heart rate, weight, and step count in HyperCoach. At the end of every week, participants will have the opportunity to have a progress report available to them to demonstrate their current trends regarding their weight, blood pressure, resting heart rate, and step count. The progress report will also allow users to change their current goals for more appropriate ones according to their health and knowledge development.
The 40 participants will be provided with a Bluetooth-enabled blood pressure cuff and weight scale. The devices will be used alongside the participants' IOS phones to collect their blood pressure and weight readings through the use of the iPhone Application - HyperCoach. The application will provide the participants with American Heart Association (AHA) approved content in the form of flyers, messages, and videos. The application automatically saves the measurements of the participant as long as the application is open and Bluetooth is functional. The app will look at the readings of the participants and assess their status (green, yellow, orange, red) based on the algorithm provided by the AHA and provide a visual representation of the participant's health trends.
References: All coaching content has been designed or selected with the input of one of our sponsors, the American Heart Association. Content that will be provided may be found on the American Heart Association website, Pennington Biomedical Research Center website(under Pennington Nutrition Series), and Harvard Health Publishing website. Also, some videos that will be shown to the participants may be found under the following Youtube Channels: American Heart Association, Sanitas, British Heart Foundation, and SabiasMass. These Youtube Channels cover relevant health coaching information that has been reviewed for inclusion.
Questionnaires: All questionnaires will be performed through Qualtrics, except for the consent form, which will be signed through DocuSign.
HyperCoach: The application will send daily reminders through phone notifications through the HyperCoach app to complete their measurement (weight and blood pressure), review educational material, and complete their knowledge assessments. The application only permits participants to track their health measurements and access educational content to improve their health. It is not providing any treatment options to the participant regarding their condition. The purpose is to allow them to know their current medical measurements (weight & blood pressure) and provide health coaching to advise them on improving their health.
Data Collection: Information about the participant will be stored in a locked file cabinet. Computer files are protected with a password. Participant contact information will be deleted after successful completion of this study.
The clinical outcomes of the study are the following:
- Average change in systolic BP
- Average change in diastolic BP
- % of change from baseline to follow-up
- % of individuals changing from one hypertension classification to another
- Average weight change
- Quality of life (SF-36)
- Changes in health beliefs
- Change in hypertension health literacy
- Level of engagement with the intervention The hypothesis is that those receiving health belief-tailored messaging and health coaching will have more significant changes in their beliefs, quality of life, and a higher level of engagement with the app as compared to the others. An Exit Interview will be conducted at the end of the study to take their feedback on the study.
To differentiate between the two participant groups:
The non-coaching group will only have access to the daily reminders and trend graphs for the duration of the study.
Group Assignment:
The participants will be assigned to their group according to the order they sign-up for the study. Every third person who registers for the study will be in the non-coaching group, and all others in the coaching group.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Texas
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College Station, Texas, Spojené státy, 77843
- Texas A&M University
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Reliable internet access for mobile device (either WIFI or mobile data plan)
- iOS (14+) smarthphone (iPhone 6S or newer)
- Fluent in English or Spanish
- Participant is taking hypertension medication
- Diagnosis is hypertension
- 18+ years of age
Exclusion Criteria:
- Diagnosed with resistant hypertension
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Digital Coaching
A study will be conducted where participants will be guided through a 90-day hypertension AHA-approved care plan, and 180-days later, will be checked for self-sustainability.
The coaching plan that has been developed was created through AHA-approved content and guidelines.
The participants will be provided with a blood pressure cuff and a weight scale.
The iPhone application will provide the coaching group participants with a combination of educational content and motivational messages.
|
The participants will have the opportunity to establish their own personal health goals for blood pressure, resting heart rate, weight, and step count in HyperCoach.
At the end of every week, participants will have the opportunity to have a progress report available to them to demonstrate their current trends regarding their weight, blood pressure, resting heart rate, and step count.
The progress report will also allow users to change their current goals to more appropriate ones according to their health and knowledge development.
The participants will be provided with a Bluetooth-enabled blood pressure cuff and weight scale.
The devices will be used alongside the participants' IOS phones to collect their blood pressure and weight readings through the use of the iPhone Application - HyperCoach.
The application will provide the participants with American Heart Association (AHA) approved content in the form of flyers, messages, and videos.
Ostatní jména:
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Aktivní komparátor: Health Awareness
The Health Awareness group will only receive daily reminders to complete their measurements, the ability to track, and display their data trends in a graph.
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Daily reminders to monitor bloodp pressure and weight , mobile platform functions are disabled except for biofeedback and trend graphs.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Baseline Systolic Blood Pressure
Časové okno: From enrollment to Day 90 and 270 of the intervention.
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Blood pressure was measured by participants using a blood pressure cuff.
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From enrollment to Day 90 and 270 of the intervention.
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Change in Baseline Diastolic Blood Pressure
Časové okno: From enrollment to the end of the treatment at Day 90 and 270.
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Blood pressure was measured by the participants using blood pressure cuffs.
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From enrollment to the end of the treatment at Day 90 and 270.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Changes from Baseline Weight to Study Conclusion from Baseline to Day 90 and Day 270
Časové okno: From enrollment to the end of treatment at 90 days and 270 days.
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Total change in body weight in pounds measured with a weight scale.
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From enrollment to the end of treatment at 90 days and 270 days.
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Change from Quality of Life (SF-36) Score from Baseline to Day 90 and Day 270
Časové okno: Surveys will be completed on enrollment, day 90, and day 270 of the study.
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Participants will complete the Quality of Life (SF-36) survey before beginning the Digital Coaching or Health Awareness intervention.
The survey will be administered again at the 90-day and 270-day study time points.
The SF-36 has a maximum score of 100, indicating that participants perceive themselves to be in excellent mental and physical health, whereas a minimum score of 0 indicates the poorest perceived health status.
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Surveys will be completed on enrollment, day 90, and day 270 of the study.
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Change in Health Belief Analysis Score from Baseline to Day 90 and Day 270
Časové okno: Surveys will be completed at enrollment, on day 90, and on day 270 of the study.
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Participants will complete the Health Belief Analysis (composed of the following scores: Perceived Health Threat, Self-Efficacy, Perceived Barriers, and Cues to Action).
All survey items are measured using a 7-point Likert scale ranging from 1 ("Strongly Disagree") to 7 ("Strongly Agree").
Higher scores indicate greater agreement with the construct being measured.
For each individual subconstruct from each survey, higher scores represent higher levels of the corresponding construct.
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Surveys will be completed at enrollment, on day 90, and on day 270 of the study.
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Changes in Technology Acceptance Model Score from Baseline to Day 90 and Day 270
Časové okno: Surveys will be completed at enrollment, on day 90, and on day 270 of the study.
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Participants will complete the Technology Acceptance Model (composed of the following scores: Attitude, Perceived Usefulness, and Perceived Ease of Use).
All survey items are measured using a 7-point Likert scale ranging from 1 ("Strongly Disagree") to 7 ("Strongly Agree").
Higher scores indicate greater agreement with the construct being measured.
For each individual subconstruct from each survey (i.e., perceived ease of use), higher scores represent higher levels of the corresponding construct. .
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Surveys will be completed at enrollment, on day 90, and on day 270 of the study.
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Changes in Dual Factor Models from Baseline to Day 90 and Day 270
Časové okno: Surveys will be completed at enrollment, on day 90, and on day 270 of the study.
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Participants will complete the Dual Factor model (composed of the Resistance to Change score).
All survey items are measured using a 7-point Likert scale ranging from 1 ("Strongly Disagree") to 7 ("Strongly Agree").
Higher scores indicate greater agreement with the construct being measured.
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Surveys will be completed at enrollment, on day 90, and on day 270 of the study.
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Completion of blood pressure measurements on the HyperCoach Platform
Časové okno: Participant activities will be tracked from the day of enrollment through day 90, and subsequently through day 270.
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Participants' adherence will be assessed based on the completion of morning and evening blood pressure measurements recorded within the HyperCoach application throughout the intervention period.
Higher completion rates of scheduled blood pressure measurements will indicate greater adherence to the study protocol.
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Participant activities will be tracked from the day of enrollment through day 90, and subsequently through day 270.
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Completion of weight measurements on the HyperCoach Platform
Časové okno: Participant activities will be tracked from the day of enrollment through day 90, and subsequently through day 270.
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Participants' adherence will be assessed based on the completion of their daily weight measurements recorded within the HyperCoach application throughout the intervention period.
Higher completion rates of weight measurements will indicate greater adherence to the study protocol.
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Participant activities will be tracked from the day of enrollment through day 90, and subsequently through day 270.
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Completion of digital health coaching tasks on the HyperCoach Platform
Časové okno: Participant activities will be tracked from the day of enrollment through day 90.
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For participants assigned to the Digital Coaching group, adherence will also be assessed based on the completion of assigned coaching tasks within the HyperCoach application throughout the intervention period.
Higher completion rates of coaching tasks will indicate greater engagement and adherence to the Digital Coaching intervention.
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Participant activities will be tracked from the day of enrollment through day 90.
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Changes in Short Assessment of Health Literacy (SAHL) from Baseline to Day 90 and Day 270
Časové okno: Surveys will be completed at enrollment, on day 90, and on day 270 of the study.
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Participants will complete the Short Assessment of Health Literacy survey before beginning the intervention period.
The survey consists of 18 items designed to assess participants' health literacy.
Scores range from 0 to 18, with higher scores indicating greater health literacy and a better ability to understand and apply health-related information.
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Surveys will be completed at enrollment, on day 90, and on day 270 of the study.
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Change of Hypertension Health Literacy from Baseline to Day 90 and Day 270
Časové okno: Surveys will be completed at enrollment, on day 90, and on day 270 of the study.
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Participants will complete a health literacy and health behavior survey composed of multiple sections assessing general and health condition literacy.
The survey is composed of 61 questions: including 15 questions regarding health behaviors, 18 questions for General Health Literacy Assessment, 5 questions assessing Diabetes Literacy, 5 questions assessing High Blood Pressure Literacy, 5 questions assessing Cholesterol Literacy, 5 questions assessing Heart Failure Literacy, and 8 questions assessing Cardiometabolic Literacy.
Higher scores indicate greater health literacy.
Lower scores indicate more limited health literacy and understanding of chronic disease management.
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Surveys will be completed at enrollment, on day 90, and on day 270 of the study.
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- IRB2022-1153DCR
- M1800598 (Jiné číslo grantu/financování: NSF Engineering Research Center for Precise Advanced Technologies and Health Systems for Under-resourced Populations)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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