NCT05259280

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2022

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 28, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2022

Completed
Last Updated

November 2, 2023

Status Verified

October 1, 2023

Enrollment Period

8 months

First QC Date

January 24, 2022

Last Update Submit

October 31, 2023

Conditions

COPDChronic Obstructive Pulmonary DiseaseChronic Obstructive Pulmonary Disease SevereChronic Obstructive Pulmonary Disease Moderate

Keywords

COPDVirtual CareDigital HealthV1C

Outcome Measures

Primary Outcomes (8)

  • COPD Symptoms Assessment

    Change in self-reported symptoms as collected in the app.

    Change from baseline to 12 weeks

  • COPD Symptoms Assessment

    Change in self-reported symptoms as collected in the app.

    Change from baseline to 24 weeks

  • COPD Self-Efficacy Scale

    Change in COPD Self-Efficacy Scale

    Change from baseline to 12 weeks

  • COPD Self-Efficacy Scale

    Change in COPD Self-Efficacy Scale

    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.

    12 weeks

  • Patient-Reported Healthcare Resource Utilization (HRU)

    Measure of health resource utilization from period 12 to 24 weeks. Emergency room visits. Hospitalizations.

    24 weeks

  • Modified Medical Research Council Dyspnea Scale (mMRC)

    Change in mMRC score. (0-4, 0 is best)

    Change from baseline to 12 weeks

  • Modified Medical Research Council Dyspnea Scale (mMRC)

    Change in mMRC score. (0-4, 0 is best)

    Change from baseline to 24 weeks

Other Outcomes (1)

  • Participant Net Promoter Score (nPS)

    24 weeks

Study Arms (2)

Arm 1

EXPERIMENTAL

Arm 1: Subjects will receive 24 weeks of access to the Wellinks Solution.

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.

Other: Wellinks

Interventions

WellinksOTHER

Digital health and virtual care program for COPD management.

Arm 1Arm 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Current participation in other interventional clinical trials
  • Current participation in a pulmonary rehabilitation program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Wellinks

New Haven, Connecticut, 06511, United States

Location

COPD Foundation

Washington D.C., District of Columbia, 20002, United States

Location

Related Publications (1)

  • 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.

    PMID: 38335023DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gretchen McCreary

    COPD Foundation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2022

First Posted

February 28, 2022

Study Start

January 5, 2022

Primary Completion

September 8, 2022

Study Completion

September 8, 2022

Last Updated

November 2, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(2)