RECRUITING

Prospective, Observational Study of Wellinks Effect on COPD Hospital Readmissions

Conditions

COPD Respiratory Tract Disease Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Lung Diseases Exacerbation Discharge Hospitalization Readmission Virtual Care Digital Health V1C

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

POWER: Prospective, Observational Study of Wellinks Effect on COPD Hospital Readmissions

Quick Facts

Study Start:2022-07-05

Study Completion:2024-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05330507

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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)

Inclusion Criteria

Exclusion 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

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)

Contacts and Locations

Study Contact

Syed Hadi, MD

CONTACT

860-972-0546

syed.hadi@hhchealth.org

William Roman

CONTACT

860-972-1558

william.roman@hhchealth.org

Principal Investigator

Syed Hadi, MD

PRINCIPAL_INVESTIGATOR

Hartford HealthCare

Study Locations (Sites)

Hartford Hospital

Hartford, Connecticut, 06102

United States

Collaborators and Investigators

Sponsor: Convexity Scientific Inc

Syed Hadi, MD, PRINCIPAL_INVESTIGATOR, Hartford HealthCare

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-05

Study Completion Date2024-06

Study Record Updates

Study Start Date2022-07-05

Study Completion Date2024-06

Terms related to this study

Keywords Provided by Researchers

Exacerbation
Discharge
Hospitalization
Readmission
Virtual Care
Digital Health
V1C

Additional Relevant MeSH Terms

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