Healthy at Home Pilot

COPD Clinical Trial

Official title:

Healthy at Home: Feasibility Trial of Home-Based Management of Patients With Chronic Obstructive Pulmonary Disease (COPD) Using Digital Technology

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06000696
• Other study ID #: 20224690
• Status: Enrolling by invitation
• Start date: September 9, 2022
• Est. completion date: April 2024

Study information

• Verified date: August 2023
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: April 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD
• COPD Exacerbation
• Emphysema
• Emphysema or COPD

Locations

Country	Name	City	State
United States	UMass Chan Medical School	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	UMass Memorial Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enroll	Develop and use a smartphone app to enroll 100 UMass Memorial Health patients into the Healthy at Home program based on their short-term risk of requiring acute care needs.	14 months
Primary	Enhance	Enhance the existing Mobile Integrated Health (MIH) dashboard that currently only tracks care episodes by remotely collecting biometric data (oxygen saturation, respiratory rate, body temperature, heart rate) and participant reported data to allow the MIH paramedics to review longitudinal history of the patients prior to and after providing care.	18 months
Primary	Evaluate	Follow enrolled participants for six months to measure feasibility (adherence, usability) and clinical (patient-reported outcomes, healthcare utilization, total medical expenditure) outcomes at baseline, 3-months, and 6-months. Compare outcomes across full-intervention (Healthy at Home w/ virtual pulmonary therapy group), partial-intervention (Healthy at Home), and control (synthetic controls derived from EMR) after adjusting for baseline risk of acute-care needs.	24 months