Reducing Heart Failure Re-admissions by Enhancing Sleep Apnea Treatment Adherence
Primary Purpose
Congestive Heart Failure, Sleep Apnea Syndromes
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
AirCare App
Sponsored by
About this trial
This is an interventional supportive care trial for Congestive Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Congestive heart failure and sleep apnea
Exclusion Criteria:
- Cognitive impairment
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Study participants will receive a tablet computer with the AirCare system.
Standard care
Outcomes
Primary Outcome Measures
Number of Participants Adhering to Positive Airway Pressure (PAP)
PAP adherence will be measured from the PAP unit (which monitors nightly hours of use and records this data; this is the standard of care clinical practice approach used currently by health care providers to monitor PAP use) and will be reported as Number of Participants who Adhered to Positive Airway Pressure (PAP) Treatment (adherence defined as >4 hours of use per night on average across the 30 day period). For example, if 5 subjects used PAP for more than 4 hours per night on average across the 30 day period, then the number of adherent participants is 5.
Secondary Outcome Measures
Full Information
NCT ID
NCT02312765
First Posted
December 1, 2014
Last Updated
July 27, 2020
Sponsor
University of Pennsylvania
Collaborators
AirCare Labs, LLC
1. Study Identification
Unique Protocol Identification Number
NCT02312765
Brief Title
Reducing Heart Failure Re-admissions by Enhancing Sleep Apnea Treatment Adherence
Official Title
Reducing Heart Failure Re-admissions by Enhancing Sleep Apnea Treatment Adherence
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
Collaborators
AirCare Labs, LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Sleep apnea, characterized by abnormal breathing at night, is often untreated in patients with heart failure. Helping patients to effectively use the most common form of treatment for sleep apnea, positive airway pressure therapy, can improve their heart function. This can reduce the likelihood that the patient will be re-admitted to the hospital. AirCareLabs has developed an innovative solution that allows patients to communicate with health care providers 24 hours a day, thus allowing them to get the help they need to effectively use positive airway pressure and thereby reduce the risk of being re-admitted to the hospital.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure, Sleep Apnea Syndromes
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
146 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Study participants will receive a tablet computer with the AirCare system.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard care
Intervention Type
Behavioral
Intervention Name(s)
AirCare App
Intervention Description
Tablet software to encourage adherence and support
Primary Outcome Measure Information:
Title
Number of Participants Adhering to Positive Airway Pressure (PAP)
Description
PAP adherence will be measured from the PAP unit (which monitors nightly hours of use and records this data; this is the standard of care clinical practice approach used currently by health care providers to monitor PAP use) and will be reported as Number of Participants who Adhered to Positive Airway Pressure (PAP) Treatment (adherence defined as >4 hours of use per night on average across the 30 day period). For example, if 5 subjects used PAP for more than 4 hours per night on average across the 30 day period, then the number of adherent participants is 5.
Time Frame
one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Congestive heart failure and sleep apnea
Exclusion Criteria:
Cognitive impairment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nalaka Gooneratne, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Reducing Heart Failure Re-admissions by Enhancing Sleep Apnea Treatment Adherence
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