COPDPOWERNCT05330507
Prospective, Observational Study of Wellinks Effect on COPD Hospital Readmissions
An observational study of COPD and Respiratory Tract Disease, run by Convexity Scientific Inc at 1 site in United States.
Trial summary
This prospective, observational study is designed to investigate clinical outcomes and collect patient feedback on the use of Wellinks, an integrated virtual chronic obstructive pulmonary disease (COPD) management solution, for patients recently discharged from the hospital due to an acute exacerbation of their COPD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD, Respiratory Tract Disease, Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Wellinks
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2022to Jun 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with COPD hospitalized due to a COPD exacerbation are eligible for enrollment into the Wellinks intervention. Study participants are required to fulfill certain criteria for access to the internet and a smartphone. Key exclusion criteria are congestive heart failure for the potential risk to participation in virtual pulmonary rehabilitation, coincident SARS-CoV-2 infection due to the unknown impact on the post-discharge outcomes of COPD patients, and current participation in other interventional programs or active engagement in pulmonary rehabilitation. See complete list of eligibility criteria.
Who may be able to join
- 1. Adult (≥18 years of age with no upper age limit) 2. Any sex, race and ethnicity 3. COPD diagnosis 4. Current hospital admission or observation status resulting from exacerbation of COPD or generally including respiratory signs/symptoms indicative of difficulty breathing (e.g., need for oxygen or nebulized therapy, increased use of rescue medication) 4. Telephone (landline or mobile) and internet access 5. Access to a smartphone: iPhone 6S or later model, running iOS 14.0 or later; Android 6 or later model 6. Proficient in English language due to the availability of all study materials in the English language only 7. Living/staying in the United States throughout the study duration 8. Eligible to participate in asynchronous virtual pulmonary rehabilitation in the opinion of the investigator (e.g., patients determined to be ineligible to participate may include those with acute coronary syndrome for whom an exercise regimen is not advisable at present time) 9. Willing and able to comply with study requirements 10. Able to provide written informed consent
Who cannot join
- Diagnosis of acute decompensated heart failure
- Currently pregnant or planning to become pregnant during the study period
- Life expectancy <17 weeks
- Current participation in other interventional clinical trials
- Current participation in a pulmonary rehabilitation program
- 7. Enrollment in an existing Wellinks program 8. Unable or unwilling to cooperate with remote assessments and engagement with Coaches 9. Unable to comply with the study procedures in the opinion of the investigator (e.g., unlikely to be compliant, unlikely to comprehend instructions or education provided)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Hartford Hospital
Hartford, Connecticut, 06102
Syed Hadi, MD, 860-972-0546
About this study
Official title: POWER: Prospective, Observational Study of Wellinks Effect on COPD Hospital Readmissions
This prospective, observational study is designed to investigate clinical outcomes and collect patient feedback on the use of Wellinks, an integrated virtual chronic obstructive pulmonary disease (COPD) management solution, for patients recently discharged from the hospital due to an acute exacerbation of their COPD.
Read the detailed description
Wellinks, an integrated virtual COPD management solution consists of a combination of health coaching, Bluetooth-connected devices, collection of patient-reported symptoms and medication use, and virtual pulmonary rehabilitation, all centralized by the use of a mobile-phone application (mobile app) downloaded onto a study participant's iOS (iPhone) or Android device. The clinical objectives of this study are to determine whether utilization of Wellinks can reduce the rate of hospital readmissions due to a COPD exacerbation for patients recently discharged from the hospital. The nonclinical objectives of this study are to describe the experience of study participants using Wellinks through the assessment of engagement with the components of Wellinks, as well as by participant-reported satisfaction and perceived value (e.g., willingness to pay). Qualitative feedback on the features and functionality of Wellinks will be solicited.
- Conditions
- COPD, Respiratory Tract Disease, Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive, Lung Diseases
- Being tested
- Wellinks
- Keywords
- Exacerbation, Discharge, Hospitalization, Readmission, Virtual Care, Digital Health, V1C
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Respiratory Tract Diseases, Lung Diseases, Obstructive, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WellinksOther
30-day post-discharge period: virtual respiratory therapist sessions twice per week with synchronous virtual pulmonary rehabilitation and educational materials; at-home use of connected spirometer and pulse oximeter; at-home use of mobile app.
12-week intensive period: virtual health coaching sessions once every two weeks; asynchronous virtual pulmonary rehabilitation program; ongoing access to connected devices (spirometer and pulse oximeter) and mobile app.
| Study group | Role | What they receive |
|---|---|---|
| Wellinks Intervention | Following inpatient hospitalization for COPD exacerbation, participants will receive 16 weeks of access to Wellinks (i.e., connected spirometer and pulse oximeter, virtual respiratory therapist sessions with pulmonary rehabilitation, virtual health coaching sessions, mobile app access, COPD-related education). The 16-week period is comprised of a 30-day post-discharge program followed by a 12-week intensive period, which vary by frequency of contact with respiratory therapists/health coaches. Receives: Other: Wellinks | |
| Matched Controls | A matched control dataset will be extracted from electronic medical records of the participating healthcare system. Participants will be matched on an index COPD-related hospitalization and other key factors, utilizing propensity score matching (i.e., number of COPD-related hospitalizations in prior year, severity of COPD, age). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital readmission rate (all-cause)
Rate of all-cause hospital readmission
Measured: 30-days post-discharge from index event
Hospital readmission rate (all-cause)
Rate of all-cause hospital readmission
Measured: 60-days post-discharge from index event
Hospital readmission rate (all-cause)
Rate of all-cause hospital readmission
Measured: 90-days post-discharge from index event
Hospital readmission rate (COPD-related)
Rate of COPD-related hospital readmission
Measured: 30-days post-discharge from index event
Hospital readmission rate (COPD-related)
Rate of COPD-related hospital readmission
Measured: 60-days post-discharge from index event
Hospital readmission rate (COPD-related)
Rate of COPD-related hospital readmission
Measured: 90-days post-discharge from index event
COPD Assessment Test
Assess quality-of-life impact of COPD
Measured: Change from baseline to day 30 (end of post-discharge intervention phase) and to week 16 (end of study)
Exercise capacity: 30-second sit-to-stand
Assess exercise capacity
Measured: Change from baseline to day 30 (end of post-discharge intervention phase) and to week 16 (end of study)
Modified Medical Research Council Dyspnea Index (mMRC)
Assess shortness of breath and impact on daily activities
Measured: Change from baseline to day 30 (end of post-discharge intervention phase) and to week 16 (end of study)
Secondary outcomes (4)
Wellinks App Engagement
Frequency of use of the mobile app throughout the study period
Measured: 16 weeks
Wellinks Device Engagement
Frequency of use of the connected devices throughout the study period
Measured: 16 weeks
Wellinks Session Engagement
Participation rate in scheduled respiratory therapist and health coaching sessions
Measured: 16 weeks
Patient Satisfaction (Net Promoter Score)
Net promoter score from asking, "How likely is it that you would recommend Wellinks to a friend or colleague?"
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start5 Jul 2022
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case-control
- Time perspective
- Other
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Convexity Scientific Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hartford HealthCare
- Responsible party
- Sponsor
- Investigators
- Syed Hadi, MD, Principal investigator, Hartford HealthCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05330507
- Sponsor's protocol ID
- WL-2022-01-HHC
- Acronym
- POWER
- Status last verified
- Oct 2023
- First submitted
- 7 Apr 2022
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POWER: Prospective, Observational Study of Wellinks Effect on COPD Hospital Readmissions
- ClinicalTrials.gov ID
- NCT05330507
- Acronym / sponsor ID
- POWER / WL-2022-01-HHC
- Conditions
- COPD, Respiratory Tract Disease, Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive, Lung Diseases
- Keywords
- Exacerbation, Discharge, Hospitalization, Readmission, Virtual Care, Digital Health, V1C
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Convexity Scientific IncIndustry (pharma, biotech, devices)
- Collaborators
- Hartford HealthCare
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 15 Apr 2022 (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.
This prospective, observational study is designed to investigate clinical outcomes and collect patient feedback on the use of Wellinks, an integrated virtual chronic obstructive pulmonary disease (COPD) management solution, for patients recently discharged from the hospital due to an acute exacerbation of their COPD.
Detailed description
Wellinks, an integrated virtual COPD management solution consists of a combination of health coaching, Bluetooth-connected devices, collection of patient-reported symptoms and medication use, and virtual pulmonary rehabilitation, all centralized by the use of a mobile-phone application (mobile app) downloaded onto a study participant's iOS (iPhone) or Android device. The clinical objectives of this study are to determine whether utilization of Wellinks can reduce the rate of hospital readmissions due to a COPD exacerbation for patients recently discharged from the hospital. The nonclinical objectives of this study are to describe the experience of study participants using Wellinks through the assessment of engagement with the components of Wellinks, as well as by participant-reported satisfaction and perceived value (e.g., willingness to pay). Qualitative feedback on the features and functionality of Wellinks will be solicited.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wellinks Intervention | – | Other: WellinksFollowing inpatient hospitalization for COPD exacerbation, participants will receive 16 weeks of access to Wellinks (i.e., connected spirometer and pulse oximeter, virtual respiratory therapist sessions with pulmonary rehabilitation, virtual health coaching sessions, mobile app access, COPD-related education). The 16-week period is comprised of a 30-day post-discharge program followed by a 12-week intensive period, which vary by frequency of contact with respiratory therapists/health coaches. |
| Matched Controls | – | –A matched control dataset will be extracted from electronic medical records of the participating healthcare system. Participants will be matched on an index COPD-related hospitalization and other key factors, utilizing propensity score matching (i.e., number of COPD-related hospitalizations in prior year, severity of COPD, age). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with COPD hospitalized due to a COPD exacerbation are eligible for enrollment into the Wellinks intervention. Study participants are required to fulfill certain criteria for access to the internet and a smartphone. Key exclusion criteria are congestive heart failure for the potential risk to participation in virtual pulmonary rehabilitation, coincident SARS-CoV-2 infection due to the unknown impact on the post-discharge outcomes of COPD patients, and current participation in other interventional programs or active engagement in pulmonary rehabilitation. See complete list of eligibility criteria.
Key inclusion criteria (1 listed)
- 1. Adult (≥18 years of age with no upper age limit) 2. Any sex, race and ethnicity 3. COPD diagnosis 4. Current hospital admission or observation status resulting from exacerbation of COPD or generally including respiratory signs/symptoms indicative of difficulty breathing (e.g., need for oxygen or nebulized therapy, increased use of rescue medication) 4. Telephone (landline or mobile) and internet access 5. Access to a smartphone: iPhone 6S or later model, running iOS 14.0 or later; Android 6 or later model 6. Proficient in English language due to the availability of all study materials in the English language only 7. Living/staying in the United States throughout the study duration 8. Eligible to participate in asynchronous virtual pulmonary rehabilitation in the opinion of the investigator (e.g., patients determined to be ineligible to participate may include those with acute coronary syndrome for whom an exercise regimen is not advisable at present time) 9. Willing and able to comply with study requirements 10. Able to provide written informed consent
Key exclusion criteria (6 listed)
- Diagnosis of acute decompensated heart failure
- Currently pregnant or planning to become pregnant during the study period
- Life expectancy <17 weeks
- Current participation in other interventional clinical trials
- Current participation in a pulmonary rehabilitation program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wellinks30-day post-discharge period: virtual respiratory therapist sessions twice per week with synchronous virtual pulmonary rehabilitation and educational materials; at-home use of connected spirometer and pulse oximeter; at-home use of mobile app. 12-week intensive period: virtual health coaching sessions once every two weeks; asynchronous virtual pulmonary rehabilitation program; ongoing access to connected devices (spirometer and pulse oximeter) and mobile app. | Other | Wellinks Intervention |
Primary outcome
Hospital readmission rate (all-cause)
Time frame: 30-days post-discharge from index event
Rate of all-cause hospital readmission
Hospital readmission rate (all-cause)
Time frame: 60-days post-discharge from index event
Rate of all-cause hospital readmission
Hospital readmission rate (all-cause)
Time frame: 90-days post-discharge from index event
Rate of all-cause hospital readmission
Hospital readmission rate (COPD-related)
Time frame: 30-days post-discharge from index event
Rate of COPD-related hospital readmission
Hospital readmission rate (COPD-related)
Time frame: 60-days post-discharge from index event
Rate of COPD-related hospital readmission
Hospital readmission rate (COPD-related)
Time frame: 90-days post-discharge from index event
Rate of COPD-related hospital readmission
COPD Assessment Test
Time frame: Change from baseline to day 30 (end of post-discharge intervention phase) and to week 16 (end of study)
Assess quality-of-life impact of COPD
Exercise capacity: 30-second sit-to-stand
Time frame: Change from baseline to day 30 (end of post-discharge intervention phase) and to week 16 (end of study)
Assess exercise capacity
Modified Medical Research Council Dyspnea Index (mMRC)
Time frame: Change from baseline to day 30 (end of post-discharge intervention phase) and to week 16 (end of study)
Assess shortness of breath and impact on daily activities
4 secondary outcomes
Wellinks App Engagement
Time frame: 16 weeks
Wellinks Device Engagement
Time frame: 16 weeks
Wellinks Session Engagement
Time frame: 16 weeks
Patient Satisfaction (Net Promoter Score)
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
- 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.
Syed Hadi, MD principal investigator
Hartford HealthCare
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 Respiratory Tract Disease, run by Convexity Scientific Inc 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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 3 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Syed Hadi, MD (860-972-0546, syed.hadi@hhchealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital readmission rate (all-cause) (time frame: 30-days post-discharge from index event). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2023.