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Impact of Wearable Health Devices and Wellness Behavior Change Support on Health Outcomes and Healthcare Costs

18. února 2022 aktualizováno: Steven Bird, University of Massachusetts, Worcester

Impact of Wearable Health Devices and Health and Wellness Behavior Change Support on Health Outcomes and Healthcare Costs

The purpose of this study is to measure the impact of consumer-grade wearable health devices and behavior change support services, including health coaching, on health behaviors, biometrics, and healthcare costs. The study will be a randomized controlled trial with 700 participants who are employees of UMass Memorial Health Care in which 350 participants (control group) receive standard wellness and medical benefits and services for UMass Memorial Health Care employees and in which 350 participants (intervention group) receive these same standard benefits and services as well as the full Fitbit Care product suite (Fitbit wrist-worn device, Fitbit connected weight scale, and Fitbit Premium + Health Coaching service). Participants in the intervention group will be offered support in improving health behaviors that are important to them, including activity, nutrition, sleep, stress management, and medication adherence. They will also be offered support in tying these behaviors to their health goals, including blood pressure management, blood sugar management, cholesterol management, weight loss, smoking cessation, etc.

The hypothesis is that those employees in the intervention group will experience improved results compared to those in the control group. It is believed that they will have improved health behaviors, improved biometrics, and lower total healthcare costs (fewer complications, fewer hospitalizations, etc.).

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

597

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • Massachusetts
      • Worcester, Massachusetts, Spojené státy, 01655-0002
        • UMassMemorial Health Care

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • Employed by UMassMemorial Health Care
  • Receive benefits from UMassMemorial Health Care
  • Have a smartphone

Exclusion Criteria:

  • Pregnant
  • Unable to consent
  • Non-English speaking

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Výzkum zdravotnických služeb
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Fitbit Care intervention arm
The experimental arm will receive the full Fitbit Care product suite (Fitbit wrist-worn device, Fitbit connected weight scale, and Fitbit Premium + Health Coaching service). Participants in the experimental arm will also be offered support in improving health behaviors that are important to them, including activity, nutrition, sleep, stress management, and medication adherence.
Kombinovaný produkt: Fitbit Care intervention arm
Entire suite of Fitbit Care.
Žádný zásah: Fitbit study control arm
Participants in the control arm will have access to standard healthcare benefits available to all employees, but will not have access to any of the Fitbit Care interventions

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in total medical expenditures for calendar year 2020 to 2021
Časové okno: 12 months
Change in total medical expenditures from calendar year 2020 to 2021 Participant insurance claim information will be analyzed to determine the change in total medical expenditures from 2020 to 2021 and the results will be compared between the intervention and control groups.
12 months
Changes in Biometric Outcomes
Časové okno: 12 months
Participants will have biometric screening including body weight at the beginning and end of the study that will be used to determine the change in that biometric over the course of the study, and the results will be compared between the intervention and control groups.
12 months
Changes in Biometric Outcomes
Časové okno: 12 months
Participants will have biometric screenings including waist circumference at the beginning and end of the study that will be used to determine the change in that biometric over the course of the study, and the results will be compared between the intervention and control groups.
12 months
Changes in Biometric Outcomes
Časové okno: 12 months
Participants will have biometric screenings including blood pressure at the beginning and end of the study that will be used to determine the change in that biometric over the course of the study, and the results will be compared between the intervention and control groups.
12 months
Changes in Biometric Outcomes
Časové okno: 12 months
Participants will have biometric screenings including LDL cholesteral at the beginning and end of the study that will be used to determine the change in that biometric over the course of the study, and the results will be compared between the intervention and control groups.
12 months
Changes in Biometric Outcomes
Časové okno: 12 months
Participants will have biometric screenings including HDL cholesteral at the beginning and end of the study that will be used to determine the change in that biometric over the course of the study, and the results will be compared between the intervention and control groups.
12 months
Changes in Biometric Outcomes
Časové okno: 12 months
Participants will have biometric screenings including hemoglobin A1c at the beginning and end of the study that will be used to determine the change in that biometric over the course of the study, and the results will be compared between the intervention and control groups.
12 months
Changes in self-reported health behaviors and levels of motivation and confidence in making improvements
Časové okno: 3 months, 6 months, 9 months, and 12 months
Participants will complete a health behavior survey (addresses overall health, nutrition, activity, sleep, mindfulness, alcohol, and smoking behaviors as well as levels of motivation and confidence in making improvements) at the beginning of the study and every three months until the end of the study. This will be used to determine changes in behaviors, motivation, and confidence over the course of the study, and the results will be compared between the intervention and control groups. This is not done via a scale, but answers range from Strongly agree, to Somewhat agree, to Neither agree nor disagree, to Somewhat disagree, to Strongly disagree.
3 months, 6 months, 9 months, and 12 months

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Proportion of participants achieving target biometric outcomes
Časové okno: 12 months
Participants will have biometric screenings (including body weight, waist circumference, blood pressure, hemoglobin A1c, and LDL and HDL cholesterol) at the beginning and end of the study that will be used to determine, for each biometric, the percentage of participants in each study arm who reach standard clinical target values, and the percentage of participants will be compared between the intervention and control groups.
12 months
Proportion of participants achieving categorical improvement in biometric outcomes
Časové okno: 12 months
Participants will have biometric screenings (including body weight, waist circumference, blood pressure, hemoglobin A1c, and LDL and HDL cholesterol) at the beginning and end of the study that will be used to determine, for each biometric, the percentage of participants in each study arm who improve at least one clinical category (for example, from stage 2 hypertension to stage 1 hypertension, and the percentage of participants will be compared between the intervention and control groups.
12 months
Correlations between responses to health behavior survey and total medical expenditure and biometric outcomes
Časové okno: 12 months
Participant responses to the health behavior survey (behaviors as well as levels of motivation and confidence in making improvements) will be analyzed for correlations with changes in total medical expenditures and biometric outcomes.
12 months
Changes in metrics collected by Fitbit devices and Fitbit app
Časové okno: weekly and totaled over 12 months
For participants in the intervention group, changes in steps taking collected by Fitbit devices and in the Fitbit app will be analyzed over the course of the study.
weekly and totaled over 12 months
Changes in metrics collected by Fitbit devices and Fitbit app
Časové okno: weekly and totaled over 12 months
For participants in the intervention group, changes in active zone minutes collected by Fitbit devices and in the Fitbit app will be analyzed over the course of the study.
weekly and totaled over 12 months
Changes in metrics collected by Fitbit devices and Fitbit app
Časové okno: weekly and totaled over 12 months
For participants in the intervention group, changes in hours of sleep collected by Fitbit devices and in the Fitbit app will be analyzed over the course of the study.
weekly and totaled over 12 months
Correlations between metrics collected by Fitbit devices and Fitbit app and total medical expenditure and biometric outcomes
Časové okno: 12 months
For participants in the intervention group, changes in metrics collected by Fitbit devices and in the Fitbit app will be analyzed for correlations with changes in total medical expenditures and biometric outcomes.
12 months
Correlations between engagement with health coach and total medical expenditure and biometric outcomes
Časové okno: 12 months
For participants in the intervention group, engagement with the health coach in the Fitbit app will be measured based on the number of text messages and interactions with the health coaching action plan and analyzed for correlations with changes in total medical expenditures and biometric outcomes.
12 months

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of Massachusetts, Worcester

Spolupracovníci

Fitbit Inc
Massachusetts eHealth Initiative

Vyšetřovatelé

  • Vrchní vyšetřovatel: Steven Bird, MD, UMass Memorial Healthcare

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

13. ledna 2021

Primární dokončení (Aktuální)

18. ledna 2022

Dokončení studie (Aktuální)

18. ledna 2022

Termíny zápisu do studia

První předloženo

11. ledna 2021

První předloženo, které splnilo kritéria kontroly kvality

13. ledna 2021

První zveřejněno (Aktuální)

15. ledna 2021

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

21. února 2022

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

18. února 2022

Naposledy ověřeno

1. února 2022

Více informací

Termíny související s touto studií

Klíčová slova

Další identifikační čísla studie

  • H00021669
  • 2020 - MeHI - 01 (Jiné číslo grantu/financování: Massachusetts eHealth Initiative)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

IPD is not planned to share with other researchers.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Zdravotní chování

Klinické studie na Fitbit Care intervention arm

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Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

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CROs in Saint Lucia

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

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Místa

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