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

18 febbraio 2022 aggiornato da: 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.).

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

597

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Massachusetts
      • Worcester, Massachusetts, Stati Uniti, 01655-0002
        • UMassMemorial Health Care

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Prodotto combinato: Fitbit Care intervention arm
Entire suite of Fitbit Care.
Nessun intervento: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in total medical expenditures for calendar year 2020 to 2021
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of participants achieving target biometric outcomes
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Massachusetts, Worcester

Collaboratori

Fitbit Inc
Massachusetts eHealth Initiative

Investigatori

  • Investigatore principale: Steven Bird, MD, UMASS Memorial Healthcare

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

13 gennaio 2021

Completamento primario (Effettivo)

18 gennaio 2022

Completamento dello studio (Effettivo)

18 gennaio 2022

Date di iscrizione allo studio

Primo inviato

11 gennaio 2021

Primo inviato che soddisfa i criteri di controllo qualità

13 gennaio 2021

Primo Inserito (Effettivo)

15 gennaio 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

21 febbraio 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 febbraio 2022

Ultimo verificato

1 febbraio 2022

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • H00021669
  • 2020 - MeHI - 01 (Altro numero di sovvenzione/finanziamento: Massachusetts eHealth Initiative)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

IPD is not planned to share with other researchers.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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