Trial Outcomes & Findings for Reducing Heart Failure Re-admissions by Enhancing Sleep Apnea Treatment Adherence (NCT NCT02312765)

Last Updated: 2020-08-04

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

146 participants

Primary outcome timeframe

one month

Results posted on

2020-08-04

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention: AirCare System Study participants will receive a tablet computer with the AirCare system. AirCare App: Tablet software to encourage adherence and support	Control: Standard of Care Standard care consisting of routine clinical care provided by their healthcare providers
Overall Study STARTED	74	72
Overall Study COMPLETED	19	36
Overall Study NOT COMPLETED	55	36

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention: AirCare System n=74 Participants Study participants will receive a tablet computer with the AirCare system. AirCare App: Tablet software to encourage adherence and support	Control: Standard of Care n=72 Participants Standard care: This is the care that would be routinely provided by their healthcare provider	Total n=146 Participants Total of all reporting groups
Age, Continuous	58.1 years STANDARD_DEVIATION 11.9 • n=5 Participants	59.4 years STANDARD_DEVIATION 12.7 • n=7 Participants	58.7 years STANDARD_DEVIATION 12.3 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	26 Participants n=7 Participants	57 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants	46 Participants n=7 Participants	89 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) White	43 Participants n=5 Participants	33 Participants n=7 Participants	76 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	19 Participants n=5 Participants	30 Participants n=7 Participants	49 Participants n=5 Participants
Apnea Hypopnea Index (AHI, events/hr)	31.0 events/hr STANDARD_DEVIATION 25.0 • n=5 Participants	27.2 events/hr STANDARD_DEVIATION 24 • n=7 Participants	29.1 events/hr STANDARD_DEVIATION 24.4 • n=5 Participants

PRIMARY outcome

Timeframe: one month

Population: Intent to treat

Outcome measures

Outcome measures
Measure	Intervention: AirCare System n=74 Participants Study participants will receive a tablet computer with the AirCare system. AirCare App: Tablet software to encourage adherence and support	Control: Standard Care n=72 Participants Standard care: This is the care that would be routinely provided by their healthcare provider
Number of Participants Adhering to Positive Airway Pressure (PAP)	5 Participants	3 Participants

Adverse Events

Intervention: AirCare System

Serious events: 17 serious events

Other events: 1 other events

Deaths: 3 deaths

Control: Standard Care

Serious events: 17 serious events

Other events: 4 other events

Deaths: 4 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Intervention: AirCare System n=74 participants at risk Study participants will receive a tablet computer with the AirCare system. AirCare App: Tablet software to encourage adherence and support	Control: Standard Care n=72 participants at risk Standard care: This is the care that would be routinely provided by their healthcare provider
Infections and infestations Urinary Tract Infection	0.00% 0/74 • One month Adverse events were collected at the one month follow-up visit	1.4% 1/72 • One month Adverse events were collected at the one month follow-up visit
Gastrointestinal disorders Diarrhea	0.00% 0/74 • One month Adverse events were collected at the one month follow-up visit	1.4% 1/72 • One month Adverse events were collected at the one month follow-up visit
General disorders Toothache	0.00% 0/74 • One month Adverse events were collected at the one month follow-up visit	1.4% 1/72 • One month Adverse events were collected at the one month follow-up visit
Cardiac disorders Atrial Fibrillation	0.00% 0/74 • One month Adverse events were collected at the one month follow-up visit	1.4% 1/72 • One month Adverse events were collected at the one month follow-up visit
Nervous system disorders Lightheadedness	1.4% 1/74 • One month Adverse events were collected at the one month follow-up visit	0.00% 0/72 • One month Adverse events were collected at the one month follow-up visit

Additional Information

Dr Nalaka Gooneratne

University of Pennsylvania

Phone: 215 573 2048

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Intervention: AirCare System n=74 participants at risk Study participants will receive a tablet computer with the AirCare system. AirCare App: Tablet software to encourage adherence and support	Control: Standard Care n=72 participants at risk Standard care: This is the care that would be routinely provided by their healthcare provider
Cardiac disorders Aortic Stenosis	1.4% 1/74 • One month Adverse events were collected at the one month follow-up visit	0.00% 0/72 • One month Adverse events were collected at the one month follow-up visit
Cardiac disorders Atrial Fibrillation	1.4% 1/74 • One month Adverse events were collected at the one month follow-up visit	1.4% 1/72 • One month Adverse events were collected at the one month follow-up visit
Cardiac disorders CAD	5.4% 4/74 • One month Adverse events were collected at the one month follow-up visit	1.4% 1/72 • One month Adverse events were collected at the one month follow-up visit
Cardiac disorders Cardiac Arrest	0.00% 0/74 • One month Adverse events were collected at the one month follow-up visit	1.4% 1/72 • One month Adverse events were collected at the one month follow-up visit
Cardiac disorders CHF	17.6% 13/74 • One month Adverse events were collected at the one month follow-up visit	13.9% 10/72 • One month Adverse events were collected at the one month follow-up visit
Cardiac disorders Hypotension	0.00% 0/74 • One month Adverse events were collected at the one month follow-up visit	1.4% 1/72 • One month Adverse events were collected at the one month follow-up visit
Cardiac disorders Pacemaker bleeding	0.00% 0/74 • One month Adverse events were collected at the one month follow-up visit	1.4% 1/72 • One month Adverse events were collected at the one month follow-up visit
Cardiac disorders Pacemaker malfunction	0.00% 0/74 • One month Adverse events were collected at the one month follow-up visit	1.4% 1/72 • One month Adverse events were collected at the one month follow-up visit
Cardiac disorders PVT	2.7% 2/74 • One month Adverse events were collected at the one month follow-up visit	2.8% 2/72 • One month Adverse events were collected at the one month follow-up visit
Gastrointestinal disorders Abdominal Pain	1.4% 1/74 • One month Adverse events were collected at the one month follow-up visit	0.00% 0/72 • One month Adverse events were collected at the one month follow-up visit
Gastrointestinal disorders Abnormal Liver Enzymes	1.4% 1/74 • One month Adverse events were collected at the one month follow-up visit	0.00% 0/72 • One month Adverse events were collected at the one month follow-up visit
Gastrointestinal disorders GI Bleed	0.00% 0/74 • One month Adverse events were collected at the one month follow-up visit	1.4% 1/72 • One month Adverse events were collected at the one month follow-up visit
Infections and infestations Sepsis	0.00% 0/74 • One month Adverse events were collected at the one month follow-up visit	1.4% 1/72 • One month Adverse events were collected at the one month follow-up visit
Infections and infestations SIRS	1.4% 1/74 • One month Adverse events were collected at the one month follow-up visit	0.00% 0/72 • One month Adverse events were collected at the one month follow-up visit
Musculoskeletal and connective tissue disorders Gout	1.4% 1/74 • One month Adverse events were collected at the one month follow-up visit	0.00% 0/72 • One month Adverse events were collected at the one month follow-up visit
Metabolism and nutrition disorders Hypokalemia	1.4% 1/74 • One month Adverse events were collected at the one month follow-up visit	1.4% 1/72 • One month Adverse events were collected at the one month follow-up visit
Metabolism and nutrition disorders Metabolic Acidosis	1.4% 1/74 • One month Adverse events were collected at the one month follow-up visit	0.00% 0/72 • One month Adverse events were collected at the one month follow-up visit
Nervous system disorders CVA	1.4% 1/74 • One month Adverse events were collected at the one month follow-up visit	0.00% 0/72 • One month Adverse events were collected at the one month follow-up visit
Nervous system disorders Neuropathy	0.00% 0/74 • One month Adverse events were collected at the one month follow-up visit	1.4% 1/72 • One month Adverse events were collected at the one month follow-up visit
Nervous system disorders Seizure	1.4% 1/74 • One month Adverse events were collected at the one month follow-up visit	0.00% 0/72 • One month Adverse events were collected at the one month follow-up visit
Nervous system disorders Stroke	1.4% 1/74 • One month Adverse events were collected at the one month follow-up visit	0.00% 0/72 • One month Adverse events were collected at the one month follow-up visit
Nervous system disorders Syncope	1.4% 1/74 • One month Adverse events were collected at the one month follow-up visit	0.00% 0/72 • One month Adverse events were collected at the one month follow-up visit
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/74 • One month Adverse events were collected at the one month follow-up visit	1.4% 1/72 • One month Adverse events were collected at the one month follow-up visit
Respiratory, thoracic and mediastinal disorders Pneumonia	1.4% 1/74 • One month Adverse events were collected at the one month follow-up visit	0.00% 0/72 • One month Adverse events were collected at the one month follow-up visit
Respiratory, thoracic and mediastinal disorders Pulmonary Hypertension	0.00% 0/74 • One month Adverse events were collected at the one month follow-up visit	1.4% 1/72 • One month Adverse events were collected at the one month follow-up visit
Renal and urinary disorders Kidney infection	0.00% 0/74 • One month Adverse events were collected at the one month follow-up visit	1.4% 1/72 • One month Adverse events were collected at the one month follow-up visit