Reducing Heart Failure Re-admissions by Enhancing Sleep Apnea Treatment Adherence

NCT ID: NCT02312765

Last Updated: 2020-08-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Congestive Heart Failure Sleep Apnea Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention

Study participants will receive a tablet computer with the AirCare system.

Group Type EXPERIMENTAL

AirCare App

Intervention Type BEHAVIORAL

Tablet software to encourage adherence and support

Control

Standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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AirCare App

Tablet software to encourage adherence and support

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Congestive heart failure and sleep apnea

Exclusion Criteria

* Cognitive impairment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AirCare Labs, LLC

UNKNOWN

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Nalaka Gooneratne

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nalaka Gooneratne, MD

Role: STUDY_DIRECTOR

University of Pennsylvania

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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820241

Identifier Type: -

Identifier Source: org_study_id

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