Clinical trial NCT06000696: Healthy At Home Pilot
Official title: Healthy At Home: Feasibility Trial of Home-Based Management of Patients with Chronic Obstructive Pulmonary Disease (COPD) Using Digital Technology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
COPD Exacerbation
Emphysema or COPD
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: UMass Memorial Health
First posted: 2023-08-21
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of Umass Memorial Health system who have a diagnosis of COPD and live within the geographic area served by the Mobile Integrated Health program who are identified as potentially being a fit for the study program and are willing and able to download the study app and consent to the study via the app.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Enroll
timeFrame: 14 months
measure: Enhance
timeFrame: 18 months
measure: Evaluate
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Chan Medical School
state: Massachusetts
Study officials:
affiliation: University of Massachusetts Chan Medical School
name: Apurv Soni, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: