COPDASPIRENCT05259280
Observational Study of the Wellinks Solution Impact on Quality of Life and Clinical Outcomes in Patients With COPD
A study testing Wellinks in people with COPD and Chronic Obstructive Pulmonary Disease, run by Convexity Scientific Inc at 2 sites in United States.
Trial summary
The clinical objectives of this study are to determine whether utilization of the Wellinks COPD Solution can improve quality of life for patients with COPD, can reduce healthcare resource utilization over time, and can improve pulmonary function as measured by connected devices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD, Chronic Obstructive Pulmonary Disease, Chronic Obstructive Pulmonary Disease Severe
- What is being tested?
- Wellinks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Jan 2022to 8 Sep 2022
- Phase
- Interventional
- 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
Who may be able to join
- COPD diagnosis (confirmed by the patient and assumed based on participation in COPD PPRN)
- Home telephone (landline or mobile) and internet access
- Smartphone: iPhone 6S or later model, running iOS 14.0 or later; Android 6 or later model
- Proficient in English language
- Living/staying in the United States throughout the study duration
- Willing and able to comply with study requirements
- Able to provide written informed consent
Who cannot join
- Current participation in other interventional clinical trials
- Current participation in a pulmonary rehabilitation program
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Wellinks
New Haven, Connecticut, 06511
COPD Foundation
Washington D.C., District of Columbia, 20002
About this study
Official title: ASPIRE: An Observational Study of the Wellinks Solution Impact on Quality of Life and Clinical Outcomes in Patients With COPD
The clinical objectives of this study are to determine whether utilization of the Wellinks COPD Solution can improve quality of life for patients with COPD, can reduce healthcare resource utilization over time, and can improve pulmonary function as measured by connected devices.
The nonclinical objectives of this study are to describe the experience of patients using the Wellinks Solution through the assessment of patient engagement with the solution, as well as by patient-reported satisfaction with the solution and their perceived value (e.g., willingness to pay). Qualitative feedback on the features and functionality of the Wellinks Solution will be solicited.
- Conditions
- COPD, Chronic Obstructive Pulmonary Disease, Chronic Obstructive Pulmonary Disease Severe, Chronic Obstructive Pulmonary Disease Moderate
- Being tested
- Wellinks
- Keywords
- COPD, Virtual Care, Digital Health, V1C
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WellinksOther
Digital health and virtual care program for COPD management.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Arm 1: Subjects will receive 24 weeks of access to the Wellinks Solution. Receives: Other: Wellinks |
| Arm 2 | Experimental | Arm 1: Subjects will receive 24 weeks of access to the Wellinks Solution. The latter 12 weeks will be entirely asynchronous. Receives: Other: Wellinks |
What is being measured
The primary outcome is the main question the study is designed to answer.
COPD Symptoms Assessment
Change in self-reported symptoms as collected in the app.
Measured: Change from baseline to 12 weeks
COPD Symptoms Assessment
Change in self-reported symptoms as collected in the app.
Measured: Change from baseline to 24 weeks
COPD Self-Efficacy Scale
Change in COPD Self-Efficacy Scale
Measured: Change from baseline to 12 weeks
COPD Self-Efficacy Scale
Change in COPD Self-Efficacy Scale
Measured: Change from baseline to 24 weeks
Patient-Reported Healthcare Resource Utilization (HRU)
Measure of health resource utilization from period baseline to 12 weeks. Emergency room visits. Hospitalizations.
Measured: 12 weeks
Patient-Reported Healthcare Resource Utilization (HRU)
Measure of health resource utilization from period 12 to 24 weeks. Emergency room visits. Hospitalizations.
Measured: 24 weeks
Modified Medical Research Council Dyspnea Scale (mMRC)
Change in mMRC score. (0-4, 0 is best)
Measured: Change from baseline to 12 weeks
Modified Medical Research Council Dyspnea Scale (mMRC)
Change in mMRC score. (0-4, 0 is best)
Measured: Change from baseline to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start5 Jan 2022
- Primary completion8 Sep 2022
- Study completion8 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Convexity Scientific Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- COPD Foundation
- Responsible party
- Sponsor
- Investigators
- Gretchen McCreary, Study director, COPD Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05259280
- Sponsor's protocol ID
- WL-2021-02-COPDF
- Acronym
- ASPIRE
- Status last verified
- Oct 2023
- First submitted
- 24 Jan 2022
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pierz KA, Locantore N, McCreary G, Calvey RJ, Hackney N, Doshi P, Linnell J, Sundaramoorthy A, Reed CR, Yates J. Investigation of the Impact of Wellinks on the Quality of Life and Clinical Outcomes in Patients With Chronic Obstructive Pulmonary Disease: Interventional Research Study. JMIR Form Res. 2024 Feb 9;8:e47555. doi: 10.2196/47555.
PubMed 38335023
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASPIRE: An Observational Study of the Wellinks Solution Impact on Quality of Life and Clinical Outcomes in Patients With COPD
- ClinicalTrials.gov ID
- NCT05259280
- Acronym / sponsor ID
- ASPIRE / WL-2021-02-COPDF
- Conditions
- COPD, Chronic Obstructive Pulmonary Disease, Chronic Obstructive Pulmonary Disease Severe, Chronic Obstructive Pulmonary Disease Moderate
- Keywords
- COPD, Virtual Care, Digital Health, V1C
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Convexity Scientific IncIndustry (pharma, biotech, devices)
- Collaborators
- COPD Foundation
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 8 Sep 2022 (actual)
- Study completion
- 8 Sep 2022 (actual)
- First posted
- 28 Feb 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.
The clinical objectives of this study are to determine whether utilization of the Wellinks COPD Solution can improve quality of life for patients with COPD, can reduce healthcare resource utilization over time, and can improve pulmonary function as measured by connected devices.
The nonclinical objectives of this study are to describe the experience of patients using the Wellinks Solution through the assessment of patient engagement with the solution, as well as by patient-reported satisfaction with the solution and their perceived value (e.g., willingness to pay). Qualitative feedback on the features and functionality of the Wellinks Solution will be solicited.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Other: WellinksArm 1: Subjects will receive 24 weeks of access to the Wellinks Solution. |
| Arm 2 | Experimental | Other: WellinksArm 1: Subjects will receive 24 weeks of access to the Wellinks Solution. The latter 12 weeks will be entirely asynchronous. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- COPD diagnosis (confirmed by the patient and assumed based on participation in COPD PPRN)
- Home telephone (landline or mobile) and internet access
- Smartphone: iPhone 6S or later model, running iOS 14.0 or later; Android 6 or later model
- Proficient in English language
- Living/staying in the United States throughout the study duration
Key exclusion criteria (2 listed)
- 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 |
|---|---|---|
| WellinksDigital health and virtual care program for COPD management. | Other | Arm 1, Arm 2 |
Primary outcome
COPD Symptoms Assessment
Time frame: Change from baseline to 12 weeks
Change in self-reported symptoms as collected in the app.
COPD Symptoms Assessment
Time frame: Change from baseline to 24 weeks
Change in self-reported symptoms as collected in the app.
COPD Self-Efficacy Scale
Time frame: Change from baseline to 12 weeks
Change in COPD Self-Efficacy Scale
COPD Self-Efficacy Scale
Time frame: Change from baseline to 24 weeks
Change in COPD Self-Efficacy Scale
Patient-Reported Healthcare Resource Utilization (HRU)
Time frame: 12 weeks
Measure of health resource utilization from period baseline to 12 weeks. Emergency room visits. Hospitalizations.
Patient-Reported Healthcare Resource Utilization (HRU)
Time frame: 24 weeks
Measure of health resource utilization from period 12 to 24 weeks. Emergency room visits. Hospitalizations.
Modified Medical Research Council Dyspnea Scale (mMRC)
Time frame: Change from baseline to 12 weeks
Change in mMRC score. (0-4, 0 is best)
Modified Medical Research Council Dyspnea Scale (mMRC)
Time frame: Change from baseline to 24 weeks
Change in mMRC score. (0-4, 0 is best)
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 2 Nov 2023.
- Derived from this study: PubMed 38335023Pierz KA, Locantore N, McCreary G, Calvey RJ, Hackney N, Doshi P, Linnell J, Sundaramoorthy A, Reed CR, Yates J. Investigation of the Impact of Wellinks on the Quality of Life and Clinical Outcomes in Patients With Chronic Obstructive Pulmonary Disease: Interventional Research Study. JMIR Form Res. 2024 Feb 9;8:e47555. doi: 10.2196/47555.
- 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.
Gretchen McCreary study director
COPD Foundation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wellinks in people with COPD and Chronic Obstructive Pulmonary Disease, run by Convexity Scientific Inc at 2 sites 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 7 inclusion and 2 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 2 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 2 sites 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?
COPD Symptoms Assessment (time frame: Change from baseline to 12 weeks). The study lists 8 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 NCT05259280, which also lists 1 linked publication.
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 2 Nov 2023.