COPDNCT06000696
Healthy At Home Pilot
An observational study of COPD and COPD Exacerbation, run by University of Massachusetts, Worcester at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- COPD, COPD Exacerbation, Emphysema or COPD
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2022to 30 Aug 2024
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UMass Chan Medical School
Worcester, Massachusetts, 01655
About this study
Official title: Healthy At Home: Feasibility Trial of Home-Based Management of Patients with Chronic Obstructive Pulmonary Disease (COPD) Using Digital Technology
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
Read the 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.
- Conditions
- COPD, COPD Exacerbation, Emphysema or COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start9 Sep 2022
- Primary completion30 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- UMass Memorial Health
- Responsible party
- Principal investigator, Apurv Soni, University of Massachusetts, Worcester
- Investigators
- Apurv Soni, MD, PhD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06000696
- Sponsor's protocol ID
- 20224690
- Status last verified
- Oct 2024
- First submitted
- 14 Aug 2023
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39468649O'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.
PubMed 38746125
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy At Home: Feasibility Trial of Home-Based Management of Patients with Chronic Obstructive Pulmonary Disease (COPD) Using Digital Technology
- ClinicalTrials.gov ID
- NCT06000696
- Acronym / sponsor ID
- 20224690
- Conditions
- COPD, COPD Exacerbation, Emphysema or COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- UMass Memorial Health
- Study start
- 9 Sep 2022 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Derived from this study: PubMed 39468649O'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.
- Derived from this study: PubMed 38746125O'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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Apurv Soni, MD, PhD principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and COPD Exacerbation, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enroll (time frame: 14 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06000696, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.