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OpenTrials
Completed

NCT Number: NCT06000696

Healthy At Home Pilot

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

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Key information

Conditions

COPD COPD Exacerbation Chronic Disease Disease Attributes Emphysema Emphysema or COPD Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UMass Chan Medical School

Worcester, Massachusetts, 01655, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Enroll

    Time frame: 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.

  2. Enhance

    Time frame: 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.

  3. Evaluate

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • UMass Memorial Health

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 21, 2023
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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