Healthy At Home Pilot

NCT ID: NCT06000696

Last Updated: 2024-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-09

Study Completion Date

2024-08-30

Brief Summary

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The objective is to conduct a pilot-feasibility trial of the "Healthy at Home" program, a multimodal intervention aimed at preventing acute care needs among COPD patients. The program will feature a digital platform and virtual pulmonary rehabilitation to facilitate complex care management of UMass Memorial Health Patients

Detailed Description

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The Healthy at Home project is a pilot program aimed at improving care for patients who have COPD. This pilot aims to establish how self-management using a digital application, mobile health services, and support from a wellness coach can help achieve this goal. Participation in this study involves participants downloading a smartphone app, answering questionnaires, and wearing a Fitbit everyday, including during sleep throughout the 6-month study period. The investigators will ask that participants share their medical records and healthcare visit information through the secure study app, to help better understand how to treat patients with chronic health conditions. Participants will additionally have the option to enroll in Wellinks, a program that helps patients manage their breathing and COPD symptoms and provides patients with at-home medical equipment, one-on-one personalized virtual support from specially trained clinicians and coaches, and a separate easy-to-use app for tracking and communication.

Conditions

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COPD COPD Exacerbation Emphysema or COPD

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Receives healthcare through UMass Memorial Health
* Is at least 18 years old
* Has a self-reported or EMR observed diagnosis of COPD
* Has access to a smartphone (iPhone or Android) to download and use the study app(s)
* Lives within the geographic area served by the Mobile Integrated Health program

Exclusion Criteria

* Lacks capacity to consent
* Does not understand English
* Does not have internet access on their smartphone at home
* Are currently enrolled in another investigational clinical trial
* Are or have previously been enrolled in any Wellinks program
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UMass Memorial Health

OTHER

Sponsor Role collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role lead

Responsible Party

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Apurv Soni

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Apurv Soni, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Massachusetts Chan Medical School

Locations

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UMass Chan Medical School

Worcester, Massachusetts, United States

Site Status

Countries

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United States

References

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O'Connor L, Behar S, Tarrant S, Stamegna P, Pretz C, Wang B, Savage B, Scornavacca TT, Shirshac J, Wilkie T, Hyder M, Zai A, Toomey S, Mullen M, Fisher K, Tigas E, Wong S, McManus DD, Alper E, Lindenauer PK, Dickson E, Broach J, Kheterpal V, Soni A. Rationale and design of healthy at home for COPD: an integrated remote patient monitoring and virtual pulmonary rehabilitation pilot study. Pilot Feasibility Stud. 2024 Oct 28;10(1):131. doi: 10.1186/s40814-024-01560-x.

Reference Type DERIVED
PMID: 39468649 (View on PubMed)

O'Connor L, Behar S, Tarrant S, Stamegna P, Pretz C, Wang B, Savage B, Scornavacca T, Shirshac J, Wilkie T, Hyder M, Zai A, Toomey S, Mullen M, Fisher K, Tigas E, Wong S, McManus DD, Alper E, Lindenauer PK, Dickson E, Broach J, Kheterpal V, Soni A. Rationale and Design of Healthy at Home for COPD: an Integrated Remote Patient Monitoring and Virtual Pulmonary Rehabilitation Pilot Study. Res Sq [Preprint]. 2024 Apr 29:rs.3.rs-3901309. doi: 10.21203/rs.3.rs-3901309/v1.

Reference Type DERIVED
PMID: 38746125 (View on PubMed)

Other Identifiers

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20224690

Identifier Type: -

Identifier Source: org_study_id

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