Healthy at Home Pilot

Sponsor

University of Massachusetts, Worcester (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT06000696

Collaborator

UMass Memorial Health (Other)

100

Enrollment

Location

18.7

Anticipated Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
COPD COPD Exacerbation Emphysema or COPD

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 9, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Apr 1, 2024

Outcome Measures

Primary Outcome Measures

Enroll [14 months]
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.
Enhance [18 months]
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.
Evaluate [24 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UMass Chan Medical School	Worcester	Massachusetts	United States	01655

Sponsors and Collaborators

University of Massachusetts, Worcester
UMass Memorial Health

Investigators

Principal Investigator: Apurv Soni, MD, PhD, University of Massachusetts Chan Medical School

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Apurv Soni, Assistant Professor, University of Massachusetts, Worcester

ClinicalTrials.gov Identifier:

NCT06000696

Other Study ID Numbers:

20224690

First Posted:

Aug 21, 2023

Last Update Posted:

Aug 22, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Emphysema

Study Results

No Results Posted as of Aug 22, 2023