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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
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Congestive Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 1, 2014
    Last Updated
    July 27, 2020
    Sponsor
    University of Pennsylvania
    Collaborators
    AirCare Labs, LLC
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    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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