Trial Outcomes & Findings for Improving the Frequency and Quality of Sleep Apnea Care Management (NCT NCT01916655)
NCT ID: NCT01916655
Last Updated: 2019-09-06
Results Overview
objective measurement of the amount of time PAP therapy is used at the prescribed pressure
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
360 participants
Primary outcome timeframe
2 month time point
Results posted on
2019-09-06
Participant Flow
Participant milestones
| Measure |
Usual Care
standard and typical PAP educational and support protocol
Usual Care: standard and typical CPAP educational and support protocol; is the base level education and support that is provided in the other two interventions in this study.
|
Self-Management Care
Individualized self-management educational and support protocol
Self-Management Care: Provision of sleep apnea-specific self-management education and support for those who are prescribed CPAP therapy
Usual Care: standard and typical CPAP educational and support protocol; is the base level education and support that is provided in the other two interventions in this study.
|
Self-Management Mobile Care
Individualized self-management educational and support protocol delivered in part by mobile health tool
Self-Management Mobile Care: Provision of sleep apnea-specific self-management education and support for those who are prescribed CPAP therapy via mobile phone
Usual Care: standard and typical CPAP educational and support protocol; is the base level education and support that is provided in the other two interventions in this study.
|
|---|---|---|---|
|
Overall Study
STARTED
|
131
|
109
|
120
|
|
Overall Study
COMPLETED
|
116
|
89
|
91
|
|
Overall Study
NOT COMPLETED
|
15
|
20
|
29
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving the Frequency and Quality of Sleep Apnea Care Management
Baseline characteristics by cohort
| Measure |
Usual Care
n=131 Participants
standard and typical PAP educational and support protocol
Usual Care: standard and typical CPAP educational and support protocol; is the base level education and support that is provided in the other two interventions in this study.
|
Self-Management Care
n=106 Participants
Individualized self-management educational and support protocol
Self-Management Care: Provision of sleep apnea-specific self-management education and support for those who are prescribed CPAP therapy
Usual Care: standard and typical CPAP educational and support protocol; is the base level education and support that is provided in the other two interventions in this study.
|
Self-Management Mobile Care
n=111 Participants
Individualized self-management educational and support protocol delivered in part by mobile health tool
Self-Management Mobile Care: Provision of sleep apnea-specific self-management education and support for those who are prescribed CPAP therapy via mobile phone
Usual Care: standard and typical CPAP educational and support protocol; is the base level education and support that is provided in the other two interventions in this study.
|
Total
n=348 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53.1 years
STANDARD_DEVIATION 14.0 • n=5 Participants
|
51.7 years
STANDARD_DEVIATION 13.2 • n=7 Participants
|
54.3 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
53.1 years
STANDARD_DEVIATION 13.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
124 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
318 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
21 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
25 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
79 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
202 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
131 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
348 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 2 month time pointobjective measurement of the amount of time PAP therapy is used at the prescribed pressure
Outcome measures
| Measure |
Usual Care
n=131 Participants
standard and typical PAP educational and support protocol
Usual Care: standard and typical CPAP educational and support protocol; is the base level education and support that is provided in the other two interventions in this study.
|
Self-Management Care
n=106 Participants
Individualized self-management educational and support protocol
Self-Management Care: Provision of sleep apnea-specific self-management education and support for those who are prescribed CPAP therapy
Usual Care: standard and typical CPAP educational and support protocol; is the base level education and support that is provided in the other two interventions in this study.
|
Self-Management Mobile Care
n=111 Participants
Individualized self-management educational and support protocol delivered in part by mobile health tool
Self-Management Mobile Care: Provision of sleep apnea-specific self-management education and support for those who are prescribed CPAP therapy via mobile phone
Usual Care: standard and typical CPAP educational and support protocol; is the base level education and support that is provided in the other two interventions in this study.
|
|---|---|---|---|
|
Positive Airway Pressure Adherence
|
3.9 Hours
Standard Deviation 2.2
|
3.9 Hours
Standard Deviation 2.4
|
3.8 Hours
Standard Deviation 2.4
|
Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Self-Management Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Self-Management Mobile Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place