Impact of Wearable Health Devices and Wellness Behavior Change Support on Health Outcomes and Healthcare Costs
18. februar 2022 oppdatert av: 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.).
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
597
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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Massachusetts
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Worcester, Massachusetts, Forente stater, 01655-0002
- UMassMemorial Health Care
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
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Entire suite of Fitbit Care.
|
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Ingen inngripen: 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in total medical expenditures for calendar year 2020 to 2021
Tidsramme: 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.
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12 months
|
|
Changes in Biometric Outcomes
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
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12 months
|
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Changes in Biometric Outcomes
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
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12 months
|
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Changes in self-reported health behaviors and levels of motivation and confidence in making improvements
Tidsramme: 3 months, 6 months, 9 months, and 12 months
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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.
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3 months, 6 months, 9 months, and 12 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Proportion of participants achieving target biometric outcomes
Tidsramme: 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.
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12 months
|
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Proportion of participants achieving categorical improvement in biometric outcomes
Tidsramme: 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
|
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Correlations between responses to health behavior survey and total medical expenditure and biometric outcomes
Tidsramme: 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.
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12 months
|
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Changes in metrics collected by Fitbit devices and Fitbit app
Tidsramme: 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.
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weekly and totaled over 12 months
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Changes in metrics collected by Fitbit devices and Fitbit app
Tidsramme: weekly and totaled over 12 months
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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.
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weekly and totaled over 12 months
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Changes in metrics collected by Fitbit devices and Fitbit app
Tidsramme: weekly and totaled over 12 months
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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.
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weekly and totaled over 12 months
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Correlations between metrics collected by Fitbit devices and Fitbit app and total medical expenditure and biometric outcomes
Tidsramme: 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.
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12 months
|
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Correlations between engagement with health coach and total medical expenditure and biometric outcomes
Tidsramme: 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.
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12 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Steven Bird, MD, UMass Memorial Healthcare
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
13. januar 2021
Primær fullføring (Faktiske)
18. januar 2022
Studiet fullført (Faktiske)
18. januar 2022
Datoer for studieregistrering
Først innsendt
11. januar 2021
Først innsendt som oppfylte QC-kriteriene
13. januar 2021
Først lagt ut (Faktiske)
15. januar 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
21. februar 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. februar 2022
Sist bekreftet
1. februar 2022
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- H00021669
- 2020 - MeHI - 01 (Annet stipend/finansieringsnummer: Massachusetts eHealth Initiative)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
IPD is not planned to share with other researchers.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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