Prospective, Observational Study of Wellinks Effect on COPD Hospital Readmissions

NCT05330507 | Unknown

• 1 other identifier: WL-2022-01-HHC
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COPD; Respiratory Tract Disease; Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive; Lung Diseases

Keywords

Exacerbation; Discharge; Hospitalization; Readmission; Virtual Care; Digital Health; V1C

Outcome Measures

Primary Outcomes (9)

• Hospital readmission rate (all-cause)

  Rate of all-cause hospital readmission

  30-days post-discharge from index event

• Hospital readmission rate (all-cause)

  Rate of all-cause hospital readmission

  60-days post-discharge from index event

• Hospital readmission rate (all-cause)

  Rate of all-cause hospital readmission

  90-days post-discharge from index event

• Hospital readmission rate (COPD-related)

  Rate of COPD-related hospital readmission

  30-days post-discharge from index event

• Hospital readmission rate (COPD-related)

  Rate of COPD-related hospital readmission

  60-days post-discharge from index event

• Hospital readmission rate (COPD-related)

  Rate of COPD-related hospital readmission

  90-days post-discharge from index event

• COPD Assessment Test

  Assess quality-of-life impact of COPD

  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

  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

  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

  16 weeks

• Wellinks Device Engagement

  16 weeks

• Wellinks Session Engagement

  16 weeks

• Patient Satisfaction (Net Promoter Score)

  16 weeks

Other Outcomes (1)

• Value Ranking of Wellinks Features

  16 weeks

Study Arms (2)

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.

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).

Interventions

Wellinks OTHER

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.

Wellinks Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• \. 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

You may not qualify if:

• 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
• \. 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)

Sponsors & Collaborators

• Convexity Scientific Inc: lead
• Hartford HealthCare: collaborator

Study Sites (1)

Hartford Hospital

Hartford, Connecticut, 06102, United States

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Condition Hierarchy (Ancestors)

Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Syed Hadi, MD

  Hartford HealthCare

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Syed Hadi, MD

CONTACT

860-972-0546; syed.hadi@hhchealth.org

William Roman

CONTACT

860-972-1558; william.roman@hhchealth.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 15, 2022
• Study Start: July 5, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: November 3, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)