Recruiting

Wellinks

Sponsor:

Convexity Scientific Inc

Code:

NCT05330507

Conditions

COPD

Respiratory Tract Disease

Pulmonary Disease, Chronic Obstructive

Lung Diseases, Obstructive

Lung Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Wellinks

Study Details

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

Study ID

NCT05330507

Start date

Jul 5, 2022

Status verified date

Oct, 2023

Completion date

Jun, 2024

Anticipated

Primary completion date

Jun, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

1. Diagnosis of acute decompensated heart failure
2. Currently pregnant or planning to become pregnant during the study period
3. Life expectancy <17 weeks
4. Current participation in other interventional clinical trials
5. 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)

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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

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.

Primary outcome measure

  • Hospital readmission rate (all-cause) [ Time Frame: 30-days post-discharge from index event ]
  • Hospital readmission rate (all-cause) [ Time Frame: 60-days post-discharge from index event ]
  • Hospital readmission rate (all-cause) [ Time Frame: 90-days post-discharge from index event ]
  • Hospital readmission rate (COPD-related) [ Time Frame: 30-days post-discharge from index event ]
  • Hospital readmission rate (COPD-related) [ Time Frame: 60-days post-discharge from index event ]
  • Hospital readmission rate (COPD-related) [ Time Frame: 90-days post-discharge from index event ]
  • COPD Assessment Test [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: Change from baseline to day 30 (end of post-discharge intervention phase) and to week 16 (end of study) ]

Central Contacts and Locations

Locations

Hartford Hospital

Recruiting

Hartford, Connecticut, United States, 06102

Contacts

Syed Hadi, MD

860-972-0546

More Information

Sponsor

Convexity Scientific Inc

Last update posted

Nov 3, 2023

Last verified

Oct, 2023

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Convexity Scientific Inc on 2023-11-03.