Healthy At Home Pilot

NCT06000696 | Completed

• 1 other identifier: 20224690
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

COPD; COPD Exacerbation; Emphysema or COPD

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• UMass Memorial Health: collaborator

Study Sites (1)

UMass Chan Medical School

Worcester, Massachusetts, 01655, United States

Location

Related Publications (2)

• 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.

  PMID: 39468649 DERIVED

• 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.

  PMID: 38746125 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Emphysema

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Apurv Soni, MD, PhD

  University of Massachusetts Chan Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 21, 2023
• Study Start: September 9, 2022
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)