Back to resultsObservational Study of the Wellinks Solution Impact on Quality of Life and Clinical Outcomes in Patients With COPD (ASPIRE)
Primary Purpose
COPD, Chronic Obstructive Pulmonary Disease, Chronic Obstructive Pulmonary Disease Severe
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wellinks
Sponsored by
About this trial
This is an interventional supportive care trial for COPD focused on measuring COPD, Virtual Care, Digital Health, V1C
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Current participation in other interventional clinical trials
- Current participation in a pulmonary rehabilitation program
Sites / Locations
- Wellinks
- COPD Foundation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm 1
Arm 2
Arm Description
Arm 1: Subjects will receive 24 weeks of access to the Wellinks Solution.
Arm 1: Subjects will receive 24 weeks of access to the Wellinks Solution. The latter 12 weeks will be entirely asynchronous.
Outcomes
Primary Outcome Measures
COPD Symptoms Assessment
Change in self-reported symptoms as collected in the app.
COPD Symptoms Assessment
Change in self-reported symptoms as collected in the app.
COPD Self-Efficacy Scale
Change in COPD Self-Efficacy Scale
COPD Self-Efficacy Scale
Change in COPD Self-Efficacy Scale
Patient-Reported Healthcare Resource Utilization (HRU)
Measure of health resource utilization from period baseline to 12 weeks. Emergency room visits. Hospitalizations.
Patient-Reported Healthcare Resource Utilization (HRU)
Measure of health resource utilization from period 12 to 24 weeks. Emergency room visits. Hospitalizations.
Modified Medical Research Council Dyspnea Scale (mMRC)
Change in mMRC score. (0-4, 0 is best)
Modified Medical Research Council Dyspnea Scale (mMRC)
Change in mMRC score. (0-4, 0 is best)
Secondary Outcome Measures
Full Information
NCT ID
NCT05259280
First Posted
January 24, 2022
Last Updated
February 18, 2022
Sponsor
Convexity Scientific Inc
Collaborators
COPD Foundation
1. Study Identification
Unique Protocol Identification Number
NCT05259280
Brief Title
Observational Study of the Wellinks Solution Impact on Quality of Life and Clinical Outcomes in Patients With COPD
Acronym
ASPIRE
Official Title
ASPIRE: An Observational Study of the Wellinks Solution Impact on Quality of Life and Clinical Outcomes in Patients With COPD
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 5, 2022 (Actual)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Convexity Scientific Inc
Collaborators
COPD Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Chronic Obstructive Pulmonary Disease, Chronic Obstructive Pulmonary Disease Severe, Chronic Obstructive Pulmonary Disease Moderate
Keywords
COPD, Virtual Care, Digital Health, V1C
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Arm 1: Subjects will receive 24 weeks of access to the Wellinks Solution.
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
Arm 1: Subjects will receive 24 weeks of access to the Wellinks Solution. The latter 12 weeks will be entirely asynchronous.
Intervention Type
Other
Intervention Name(s)
Wellinks
Intervention Description
Digital health and virtual care program for COPD management.
Primary Outcome Measure Information:
Title
COPD Symptoms Assessment
Description
Change in self-reported symptoms as collected in the app.
Time Frame
Change from baseline to 12 weeks
Title
COPD Symptoms Assessment
Description
Change in self-reported symptoms as collected in the app.
Time Frame
Change from baseline to 24 weeks
Title
COPD Self-Efficacy Scale
Description
Change in COPD Self-Efficacy Scale
Time Frame
Change from baseline to 12 weeks
Title
COPD Self-Efficacy Scale
Description
Change in COPD Self-Efficacy Scale
Time Frame
Change from baseline to 24 weeks
Title
Patient-Reported Healthcare Resource Utilization (HRU)
Description
Measure of health resource utilization from period baseline to 12 weeks. Emergency room visits. Hospitalizations.
Time Frame
12 weeks
Title
Patient-Reported Healthcare Resource Utilization (HRU)
Description
Measure of health resource utilization from period 12 to 24 weeks. Emergency room visits. Hospitalizations.
Time Frame
24 weeks
Title
Modified Medical Research Council Dyspnea Scale (mMRC)
Description
Change in mMRC score. (0-4, 0 is best)
Time Frame
Change from baseline to 12 weeks
Title
Modified Medical Research Council Dyspnea Scale (mMRC)
Description
Change in mMRC score. (0-4, 0 is best)
Time Frame
Change from baseline to 24 weeks
Other Pre-specified Outcome Measures:
Title
Participant Net Promoter Score (nPS)
Description
Measure of the Net Promoter Score - (How likely are you to recommend wellinks to a friend or family member?). Scale: -100 to +100, higher is better.
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Current participation in other interventional clinical trials
Current participation in a pulmonary rehabilitation program
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gretchen McCreary
Organizational Affiliation
COPD Foundation
Official's Role
Study Director
Facility Information:
Facility Name
Wellinks
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
COPD Foundation
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20002
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Observational Study of the Wellinks Solution Impact on Quality of Life and Clinical Outcomes in Patients With COPD
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