Trial Outcomes & Findings for COMMunication and Education for the New CPAP Experience (NCT NCT01377584)

Last Updated: 2017-10-02

Results Overview

The Epworth Sleepiness Scale is an 8-item questionnaire that assesses daytime sleepiness.Total scores range from 0 to 24. A score of \> 10 indicates excessive daytime sleepiness.

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

baseline and 3 months after CPAP initiation

Results posted on

2017-10-02

Participant Flow

Participant milestones

Participant milestones
Measure	Patients in the Couple-oriented Intervention Patients randomly assigned to the couple-oriented (CO) group will attend two face to face sessions and participate in an individual telephone follow-up session. Couple-oriented intervention: The first session will occur before the patient receives his/her CPAP. This session will provide the couple with education on sleep apnea and CPAP, demonstration of PAP equipment, explore patient's concerns about starting CPAP treatment, and provide a goal setting exercise. The second face to face session will occur one week after the patient receives his/her CPAP. The second session will provide the couple with information on CPAP usage and pre- and post-treatment AHI, explore barriers to CPAP use and benefits of CPAP use, and provide a goal setting exercise. The individual telephone follow-up sessions will occur two weeks after the patient has received his/her CPAP. This session will review CPAP usage and explore barriers and facilitators of CPAP use.	Partners in the Couple-oriented Intervention Partners randomly assigned to the couple-oriented (CO) group will attend two face to face sessions with the patient and participate in an individual telephone follow-up session.	Patients in the Patient-oriented Intervention Patients randomly assigned to the patient-oriented (PT) group will attend two face to face sessions and participate in a telephone follow-up session. Patient-oriented intervention: The first session will occur before the patient receives his/her CPAP. This session will provide the patient with education on sleep apnea and CPAP, demonstration of PAP equipment, explore patient's concerns about starting CPAP treatment, and provide a goal setting exercise. The second face to face session will occur one week after the patient receives his/her CPAP. The second session will provide the patient with information on CPAP usage and pre- and post-treatment AHI, explore barriers to CPAP use and benefits of CPAP use, and provide a goal setting exercise. The telephone follow-up sessions will occur two weeks after the patient has received his/her CPAP. This session will review CPAP usage and explore barriers and facilitators of CPAP use.	Partners in the Patient-oriented Intervention Partners randomly assigned to the patient-oriented (PT) group will not attend any intervention sessions.	Patients in Usual Care Patients will not attend any intervention sessions.	Partners in Usual Care Partners will not attend any intervention sessions.
Overall Study STARTED	8	8	10	10	12	12
Overall Study COMPLETED	5	5	6	6	9	9
Overall Study NOT COMPLETED	3	3	4	4	3	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

COMMunication and Education for the New CPAP Experience

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients in the Couple-oriented Intervention n=5 Participants Patients randomly assigned to the couple-oriented (CO) group will attend two face to face sessions and participate in an individual telephone follow-up session. Couple-oriented intervention: The first session will occur before the patient receives his/her CPAP. This session will provide the couple with education on sleep apnea and CPAP, demonstration of PAP equipment, explore patient's concerns about starting CPAP treatment, and provide a goal setting exercise. The second face to face session will occur one week after the patient receives his/her CPAP. The second session will provide the couple with information on CPAP usage and pre- and post-treatment AHI, explore barriers to CPAP use and benefits of CPAP use, and provide a goal setting exercise. The individual telephone follow-up sessions will occur two weeks after the patient has received his/her CPAP. This session will review CPAP usage and explore barriers and facilitators of CPAP use.	Partners in the Couple-oriented Intervention n=5 Participants Partners randomly assigned to the couple-oriented (CO) group will attend two face to face sessions with the patient and participate in an individual telephone follow-up session.	Patients in the Patient-oriented Intervention n=6 Participants Patients randomly assigned to the patient-oriented (PT) group will attend two face to face sessions and participate in a telephone follow-up session. Patient-oriented intervention: The first session will occur before the patient receives his/her CPAP. This session will provide the patient with education on sleep apnea and CPAP, demonstration of PAP equipment, explore patient's concerns about starting CPAP treatment, and provide a goal setting exercise. The second face to face session will occur one week after the patient receives his/her CPAP. The second session will provide the patient with information on CPAP usage and pre- and post-treatment AHI, explore barriers to CPAP use and benefits of CPAP use, and provide a goal setting exercise. The telephone follow-up sessions will occur two weeks after the patient has received his/her CPAP. This session will review CPAP usage and explore barriers and facilitators of CPAP use.	Partners in the Patient-oriented Intervention n=6 Participants Partners randomly assigned to the patient-oriented (PT) group will not attend any intervention sessions.	Patients in Usual Care n=9 Participants Patients will not attend any intervention sessions.	Partners in Usual Care n=9 Participants Partners will not attend any intervention sessions	Total n=40 Participants Total of all reporting groups
Age, Continuous	49 years STANDARD_DEVIATION 14 • n=5 Participants	43 years STANDARD_DEVIATION 3 • n=7 Participants	50 years STANDARD_DEVIATION 11 • n=5 Participants	54 years STANDARD_DEVIATION 14 • n=4 Participants	54 years STANDARD_DEVIATION 7 • n=21 Participants	54 years STANDARD_DEVIATION 7 • n=8 Participants	52 years STANDARD_DEVIATION 10 • n=8 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	6 Participants n=8 Participants	19 Participants n=8 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	6 Participants n=21 Participants	3 Participants n=8 Participants	21 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 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	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	4 Participants n=8 Participants	12 Participants n=8 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	5 Participants n=21 Participants	3 Participants n=8 Participants	23 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants	5 Participants n=8 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	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Apnea-Hypopnea Index	40 Events per hour of sleep STANDARD_DEVIATION 40 • n=5 Participants	NA Events per hour of sleep STANDARD_DEVIATION NA • n=7 Participants	30 Events per hour of sleep STANDARD_DEVIATION 32 • n=5 Participants	NA Events per hour of sleep STANDARD_DEVIATION NA • n=4 Participants	40 Events per hour of sleep STANDARD_DEVIATION 28 • n=21 Participants	NA Events per hour of sleep STANDARD_DEVIATION NA • n=8 Participants	37 Events per hour of sleep STANDARD_DEVIATION 31 • n=8 Participants

PRIMARY outcome

Timeframe: baseline and 3 months after CPAP initiation

The Epworth Sleepiness Scale is an 8-item questionnaire that assesses daytime sleepiness.Total scores range from 0 to 24. A score of \> 10 indicates excessive daytime sleepiness.

Outcome measures

Outcome measures
Measure	Patients in the Couple-oriented Intervention n=5 Participants Patients randomly assigned to the couple-oriented (CO) group will attend two face to face sessions and participate in an individual telephone follow-up session. Couple-oriented intervention: The first session will occur before the patient receives his/her CPAP. This session will provide the couple with education on sleep apnea and CPAP, demonstration of PAP equipment, explore patient's concerns about starting CPAP treatment, and provide a goal setting exercise. The second face to face session will occur one week after the patient receives his/her CPAP. The second session will provide the couple with information on CPAP usage and pre- and post-treatment AHI, explore barriers to CPAP use and benefits of CPAP use, and provide a goal setting exercise. The individual telephone follow-up sessions will occur two weeks after the patient has received his/her CPAP. This session will review CPAP usage and explore barriers and facilitators of CPAP use.	Partners in the Couple-oriented Intervention n=5 Participants Partners randomly assigned to the couple-oriented (CO) group will attend two face to face sessions with the patient and participate in an individual telephone follow-up session.	Patients in the Patient-oriented Intervention n=6 Participants Patients randomly assigned to the patient-oriented (PT) group will attend two face to face sessions and participate in a telephone follow-up session. Patient-oriented intervention: The first session will occur before the patient receives his/her CPAP. This session will provide the patient with education on sleep apnea and CPAP, demonstration of PAP equipment, explore patient's concerns about starting CPAP treatment, and provide a goal setting exercise. The second face to face session will occur one week after the patient receives his/her CPAP. The second session will provide the patient with information on CPAP usage and pre- and post-treatment AHI, explore barriers to CPAP use and benefits of CPAP use, and provide a goal setting exercise. The telephone follow-up sessions will occur two weeks after the patient has received his/her CPAP. This session will review CPAP usage and explore barriers and facilitators of CPAP use.	Partners in the Patient-oriented Intervention n=6 Participants Partners randomly assigned to the patient-oriented (PT) group will not attend any intervention sessions.	Patients in Usual Care n=9 Participants Patients will not attend any intervention sessions.	Partners in Usual Care n=9 Participants Partners will not attend any intervention sessions.
Daytime Sleepiness Baseline	9.0 units on a scale Standard Deviation 6.9	3.8 units on a scale Standard Deviation 1.9	6.8 units on a scale Standard Deviation 6.8	6.5 units on a scale Standard Deviation 4.6	10.8 units on a scale Standard Deviation 5.9	7.3 units on a scale Standard Deviation 5.2
Daytime Sleepiness 3 month follow-up	4.2 units on a scale Standard Deviation 0.8	1.5 units on a scale Standard Deviation 2.5	3.3 units on a scale Standard Deviation 2.1	6.9 units on a scale Standard Deviation 4.5	6.4 units on a scale Standard Deviation 4.8	4.7 units on a scale Standard Deviation 3.4
Daytime Sleepiness Change from Baseline to 3 months	-4.8 units on a scale Standard Deviation 0.8	-1.8 units on a scale Standard Deviation 1.0	-3.5 units on a scale Standard Deviation 6.7	0.4 units on a scale Standard Deviation 4.2	-4.3 units on a scale Standard Deviation 4.6	-2.7 units on a scale Standard Deviation 3.1

PRIMARY outcome

Timeframe: baseline and 3 months after CPAP initiation

The Functional Outcomes of Sleep Questionnaire-10 is 10-item questionnaire assesses the impact of sleep disorders of excessive sleepiness on multiple activities of everyday living. Scores for five domains of functioning (e.g., activity, vigilance, intimacy and sexual relationships, general productivity, and social outcome) are obtained. Each domain score ranges from 1 to 4 (1 indicating more difficulty). The total score is derived by calculating the mean of the domain scores and multiplying by five. The total score ranges from 5 to 20, with higher scores indicating greater functioning.

Outcome measures

Outcome measures
Measure	Patients in the Couple-oriented Intervention n=5 Participants Patients randomly assigned to the couple-oriented (CO) group will attend two face to face sessions and participate in an individual telephone follow-up session. Couple-oriented intervention: The first session will occur before the patient receives his/her CPAP. This session will provide the couple with education on sleep apnea and CPAP, demonstration of PAP equipment, explore patient's concerns about starting CPAP treatment, and provide a goal setting exercise. The second face to face session will occur one week after the patient receives his/her CPAP. The second session will provide the couple with information on CPAP usage and pre- and post-treatment AHI, explore barriers to CPAP use and benefits of CPAP use, and provide a goal setting exercise. The individual telephone follow-up sessions will occur two weeks after the patient has received his/her CPAP. This session will review CPAP usage and explore barriers and facilitators of CPAP use.	Partners in the Couple-oriented Intervention n=5 Participants Partners randomly assigned to the couple-oriented (CO) group will attend two face to face sessions with the patient and participate in an individual telephone follow-up session.	Patients in the Patient-oriented Intervention n=6 Participants Patients randomly assigned to the patient-oriented (PT) group will attend two face to face sessions and participate in a telephone follow-up session. Patient-oriented intervention: The first session will occur before the patient receives his/her CPAP. This session will provide the patient with education on sleep apnea and CPAP, demonstration of PAP equipment, explore patient's concerns about starting CPAP treatment, and provide a goal setting exercise. The second face to face session will occur one week after the patient receives his/her CPAP. The second session will provide the patient with information on CPAP usage and pre- and post-treatment AHI, explore barriers to CPAP use and benefits of CPAP use, and provide a goal setting exercise. The telephone follow-up sessions will occur two weeks after the patient has received his/her CPAP. This session will review CPAP usage and explore barriers and facilitators of CPAP use.	Partners in the Patient-oriented Intervention n=6 Participants Partners randomly assigned to the patient-oriented (PT) group will not attend any intervention sessions.	Patients in Usual Care n=9 Participants Patients will not attend any intervention sessions.	Partners in Usual Care n=9 Participants Partners will not attend any intervention sessions.
Sleep-related Functional Outcomes Baseline	16.6 units on a scale Standard Deviation 2.6	16.7 units on a scale Standard Deviation 2.6	17.2 units on a scale Standard Deviation 3.3	16.9 units on a scale Standard Deviation 3.9	15.6 units on a scale Standard Deviation 4.3	17.3 units on a scale Standard Deviation 2.4
Sleep-related Functional Outcomes 3 month follow-up	17.9 units on a scale Standard Deviation 0.9	18.2 units on a scale Standard Deviation 2.1	19.1 units on a scale Standard Deviation 1.5	17.3 units on a scale Standard Deviation 2.9	17.7 units on a scale Standard Deviation 2.8	18.0 units on a scale Standard Deviation 1.6
Sleep-related Functional Outcomes Change from Baseline to 3 months	2.1 units on a scale Standard Deviation 3.0	1.5 units on a scale Standard Deviation 0.7	1.9 units on a scale Standard Deviation 3.7	0.0 units on a scale Standard Deviation 1.8	2.1 units on a scale Standard Deviation 3.3	0.8 units on a scale Standard Deviation 1.1

PRIMARY outcome

Timeframe: baseline and 3 months after CPAP initiation

The Pittsburgh Sleep Quality Index (PSQI) is a 19 item questionnaire that measures self-reported sleep quality and disturbances over the last 1 month time period. The questionnaire measures 7 components of sleep quality: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. A global PSQI score is obtained by summing the 7 component scores (range = 0-21). A PSQI global score \> 5 indicates a poor sleeper.

Outcome measures

Outcome measures
Measure	Patients in the Couple-oriented Intervention n=5 Participants Patients randomly assigned to the couple-oriented (CO) group will attend two face to face sessions and participate in an individual telephone follow-up session. Couple-oriented intervention: The first session will occur before the patient receives his/her CPAP. This session will provide the couple with education on sleep apnea and CPAP, demonstration of PAP equipment, explore patient's concerns about starting CPAP treatment, and provide a goal setting exercise. The second face to face session will occur one week after the patient receives his/her CPAP. The second session will provide the couple with information on CPAP usage and pre- and post-treatment AHI, explore barriers to CPAP use and benefits of CPAP use, and provide a goal setting exercise. The individual telephone follow-up sessions will occur two weeks after the patient has received his/her CPAP. This session will review CPAP usage and explore barriers and facilitators of CPAP use.	Partners in the Couple-oriented Intervention n=5 Participants Partners randomly assigned to the couple-oriented (CO) group will attend two face to face sessions with the patient and participate in an individual telephone follow-up session.	Patients in the Patient-oriented Intervention n=6 Participants Patients randomly assigned to the patient-oriented (PT) group will attend two face to face sessions and participate in a telephone follow-up session. Patient-oriented intervention: The first session will occur before the patient receives his/her CPAP. This session will provide the patient with education on sleep apnea and CPAP, demonstration of PAP equipment, explore patient's concerns about starting CPAP treatment, and provide a goal setting exercise. The second face to face session will occur one week after the patient receives his/her CPAP. The second session will provide the patient with information on CPAP usage and pre- and post-treatment AHI, explore barriers to CPAP use and benefits of CPAP use, and provide a goal setting exercise. The telephone follow-up sessions will occur two weeks after the patient has received his/her CPAP. This session will review CPAP usage and explore barriers and facilitators of CPAP use.	Partners in the Patient-oriented Intervention n=6 Participants Partners randomly assigned to the patient-oriented (PT) group will not attend any intervention sessions.	Patients in Usual Care n=9 Participants Patients will not attend any intervention sessions.	Partners in Usual Care n=9 Participants Partners will not attend any intervention sessions.
Sleep Quality Baseline	8.4 units on a scale Standard Deviation 2.5	7.0 units on a scale Standard Deviation 2.9	7.8 units on a scale Standard Deviation 3.1	7.2 units on a scale Standard Deviation 2.1	8.3 units on a scale Standard Deviation 4.5	9.9 units on a scale Standard Deviation 3.0
Sleep Quality 3 month follow-up	5.0 units on a scale Standard Deviation 3.4	6.4 units on a scale Standard Deviation 5.0	5.8 units on a scale Standard Deviation 3.7	7.4 units on a scale Standard Deviation 3.7	6.1 units on a scale Standard Deviation 5.8	7.3 units on a scale Standard Deviation 2.8
Sleep Quality Change from Baseline to 3 months	-4.3 units on a scale Standard Deviation 3.1	-1.5 units on a scale Standard Deviation 3.5	-2.0 units on a scale Standard Deviation 1.7	-1.8 units on a scale Standard Deviation 2.2	-2.2 units on a scale Standard Deviation 4.9	-2.7 units on a scale Standard Deviation 4.4

SECONDARY outcome

Timeframe: one week, one month, and 3 months after CPAP initiation

Adherence will be measured as the amount of time that the CPAP machine is turned on and maintained at prescribed pressure. The latter number represents the amount of time power is on and the mask is positioned properly on the face. All patients will be using a CPAP machine with remote monitoring capabilities. Adherence reports are automatically uploaded to a secure data center daily. Adherence data can be accessed through the web-based patient compliance management system, EncoreAnywhere.