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Trial record 1 of 1 for:    20549372 [PUBMED-IDS]
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COMMunication and Education for the New CPAP Experience (COMMENCE)

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ClinicalTrials.gov Identifier: NCT01377584
Recruitment Status : Completed
First Posted : June 21, 2011
Results First Posted : October 2, 2017
Last Update Posted : October 2, 2017
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Faith Luyster, University of Pittsburgh

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Sleep Apnea, Obstructive
Interventions Behavioral: Couple-oriented intervention
Behavioral: Patient-oriented intervention
Device: Continuous positive airway pressure (CPAP)
Other: No intervention
Enrollment 60

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Patients in the Couple-oriented Intervention Partners in the Couple-oriented Intervention Patients in the Patient-oriented Intervention Partners in the Patient-oriented Intervention Patients in Usual Care Partners in Usual Care
Hide Arm/Group Description

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 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 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 randomly assigned to the patient-oriented (PT) group will not attend any intervention sessions. Patients will not attend any intervention sessions. Partners will not attend any intervention sessions.
Period Title: Overall Study
Started 8 8 10 10 12 12
Completed 5 5 6 6 9 9
Not Completed 3 3 4 4 3 3
Arm/Group Title Patients in the Couple-oriented Intervention Partners in the Couple-oriented Intervention Patients in the Patient-oriented Intervention Partners in the Patient-oriented Intervention Patients in Usual Care Partners in Usual Care Total
Hide Arm/Group Description

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 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 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 randomly assigned to the patient-oriented (PT) group will not attend any intervention sessions. Patients will not attend any intervention sessions. Partners will not attend any intervention sessions Total of all reporting groups
Overall Number of Baseline Participants 5 5 6 6 9 9 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 5 participants 6 participants 6 participants 9 participants 9 participants 40 participants
49  (14) 43  (3) 50  (11) 54  (14) 54  (7) 54  (7) 52  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 6 participants 6 participants 9 participants 9 participants 40 participants
Female
1
  20.0%
4
  80.0%
2
  33.3%
3
  50.0%
3
  33.3%
6
  66.7%
19
  47.5%
Male
4
  80.0%
1
  20.0%
4
  66.7%
3
  50.0%
6
  66.7%
3
  33.3%
21
  52.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 6 participants 6 participants 9 participants 9 participants 40 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
2
  33.3%
3
  50.0%
3
  33.3%
4
  44.4%
12
  30.0%
White
5
 100.0%
5
 100.0%
3
  50.0%
2
  33.3%
5
  55.6%
3
  33.3%
23
  57.5%
More than one race
0
   0.0%
0
   0.0%
1
  16.7%
1
  16.7%
1
  11.1%
2
  22.2%
5
  12.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Apnea–Hypopnea Index   [1] 
Mean (Standard Deviation)
Unit of measure:  Events per hour of sleep
Number Analyzed 5 participants 5 participants 6 participants 6 participants 9 participants 9 participants 40 participants
40  (40) NA [2]   (NA) 30  (32) NA [2]   (NA) 40  (28) NA [2]   (NA) 37  (31)
[1]
Measure Description: Apnea-Hypopnea Index is a measure of the total number of apnea and hypopnea events per hour of sleep.
[2]
Data not collected for partners.
1.Primary Outcome
Title Daytime Sleepiness
Hide Description 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.
Time Frame baseline and 3 months after CPAP initiation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients in the Couple-oriented Intervention Partners in the Couple-oriented Intervention Patients in the Patient-oriented Intervention Partners in the Patient-oriented Intervention Patients in Usual Care Partners in Usual Care
Hide Arm/Group Description:

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 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 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 randomly assigned to the patient-oriented (PT) group will not attend any intervention sessions.
Patients will not attend any intervention sessions.
Partners will not attend any intervention sessions.
Overall Number of Participants Analyzed 5 5 6 6 9 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 9.0  (6.9) 3.8  (1.9) 6.8  (6.8) 6.5  (4.6) 10.8  (5.9) 7.3  (5.2)
3 month follow-up 4.2  (0.8) 1.5  (2.5) 3.3  (2.1) 6.9  (4.5) 6.4  (4.8) 4.7  (3.4)
Change from Baseline to 3 months -4.8  (0.8) -1.8  (1.0) -3.5  (6.7) 0.4  (4.2) -4.3  (4.6) -2.7  (3.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Patients in the Couple-oriented Intervention
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Effect size
Estimated Value -0.51
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Patients in the Patient-oriented Intervention
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Effect size
Estimated Value -0.42
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Patients in Usual Care
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Effect size
Estimated Value -0.82
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Partners in the Couple-oriented Intervention
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Effect size
Estimated Value -1.31
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Partners in the Patient-oriented Intervention
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Effect size
Estimated Value -0.08
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Partners in Usual Care
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Effect size
Estimated Value -0.77
Estimation Comments [Not Specified]
2.Primary Outcome
Title Sleep-related Functional Outcomes
Hide Description 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.
Time Frame baseline and 3 months after CPAP initiation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients in the Couple-oriented Intervention Partners in the Couple-oriented Intervention Patients in the Patient-oriented Intervention Partners in the Patient-oriented Intervention Patients in Usual Care Partners in Usual Care
Hide Arm/Group Description:

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 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 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 randomly assigned to the patient-oriented (PT) group will not attend any intervention sessions.
Patients will not attend any intervention sessions.
Partners will not attend any intervention sessions.
Overall Number of Participants Analyzed 5 5 6 6 9 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 16.6  (2.6) 16.7  (2.6) 17.2  (3.3) 16.9  (3.9) 15.6  (4.3) 17.3  (2.4)
3 month follow-up 17.9  (0.9) 18.2  (2.1) 19.1  (1.5) 17.3  (2.9) 17.7  (2.8) 18.0  (1.6)
Change from Baseline to 3 months 2.1  (3.0) 1.5  (0.7) 1.9  (3.7) 0.0  (1.8) 2.1  (3.3) 0.8  (1.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Patients in the Couple-oriented Intervention
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Effect size
Estimated Value 0.51
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Patients in the Patient-oriented Intervention
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Effect size
Estimated Value 0.41
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Patients in Usual Care
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Effect size
Estimated Value 0.57
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Partners in the Couple-oriented Intervention
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Effect size
Estimated Value 1.54
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Partners in the Patient-oriented Intervention
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Effect size
Estimated Value 0.00
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Partners in Usual Care
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Effect size
Estimated Value 0.65
Estimation Comments [Not Specified]
3.Primary Outcome
Title Sleep Quality
Hide Description 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.
Time Frame baseline and 3 months after CPAP initiation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients in the Couple-oriented Intervention Partners in the Couple-oriented Intervention Patients in the Patient-oriented Intervention Partners in the Patient-oriented Intervention Patients in Usual Care Partners in Usual Care
Hide Arm/Group Description:

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 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 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 randomly assigned to the patient-oriented (PT) group will not attend any intervention sessions.
Patients will not attend any intervention sessions.
Partners will not attend any intervention sessions.
Overall Number of Participants Analyzed 5 5 6 6 9 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 8.4  (2.5) 7.0  (2.9) 7.8  (3.1) 7.2  (2.1) 8.3  (4.5) 9.9  (3.0)
3 month follow-up 5.0  (3.4) 6.4  (5.0) 5.8  (3.7) 7.4  (3.7) 6.1  (5.8) 7.3  (2.8)
Change from Baseline to 3 months -4.3  (3.1) -1.5  (3.5) -2.0  (1.7) -1.8  (2.2) -2.2  (4.9) -2.7  (4.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Patients in the Couple-oriented Intervention
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Effect size
Estimated Value -1.01
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Patients in the Patient-oriented Intervention
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Effect size
Estimated Value -0.94
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Patients in Usual Care
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Effect size
Estimated Value -0.40
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Partners in the Couple-oriented Intervention
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Effect size
Estimated Value -0.31
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Partners in the Patient-oriented Intervention
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Effect size
Estimated Value -0.65
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Partners in Usual Care
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Effect size
Estimated Value -0.77
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Continuous Positive Airway Pressure (CPAP) Adherence
Hide Description 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.
Time Frame one week, one month, and 3 months after CPAP initiation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients in the Couple-oriented Intervention Patients in the Patient-oriented Intervention Patients in Usual Care
Hide Arm/Group Description:

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.

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.

Patients will not attend any intervention sessions.
Overall Number of Participants Analyzed 5 6 9
Mean (Standard Deviation)
Unit of Measure: hours of use
1 week 5.6  (2.8) 4.5  (2.6) 5.8  (2.4)
1 month 6.1  (0.8) 5.0  (2.9) 5.1  (2.3)
Change from 1 week to 1 month 1.4  (1.9) 0.5  (0.8) -0.7  (0.7)
3 months 5.3  (2.9) 4.5  (2.8) 4.8  (2.4)
Change from 1 month to 3 months -1.6  (1.8) -0.5  (0.6) -0.3  (1.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Patients in the Couple-oriented Intervention
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Effect size
Estimated Value 0.52
Estimation Comments Comparing 1 week to 1 month
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Patients in the Couple-oriented Intervention
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Effect size
Estimated Value -0.63
Estimation Comments Comparing 1 month and 3 months
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Patients in the Patient-oriented Intervention
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Effect size
Estimated Value 0.50
Estimation Comments Comparing 1 week to 1 month
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Patients in the Patient-oriented Intervention
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Effect size
Estimated Value -0.63
Estimation Comments Comparing 1 month to 3 months
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Patients in Usual Care
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Effect size
Estimated Value -0.92
Estimation Comments Comparing 1 week to 1 month
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Patients in Usual Care
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Effect size
Estimated Value -0.26
Estimation Comments Comparing 1 month to 3 months
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Patients in the Couple-oriented Intervention Partners in the Couple-oriented Intervention Patients in the Patient-oriented Intervention Partners in the Patient-oriented Intervention Patients in Usual Care Partners in Usual Care
Hide Arm/Group Description

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 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 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 randomly assigned to the patient-oriented (PT) group will not attend any intervention sessions. Patients will not attend any intervention sessions. Partners will not attend any intervention sessions.
All-Cause Mortality
Patients in the Couple-oriented Intervention Partners in the Couple-oriented Intervention Patients in the Patient-oriented Intervention Partners in the Patient-oriented Intervention Patients in Usual Care Partners in Usual Care
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%)   0/10 (0.00%)   0/10 (0.00%)   0/12 (0.00%)   0/12 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Patients in the Couple-oriented Intervention Partners in the Couple-oriented Intervention Patients in the Patient-oriented Intervention Partners in the Patient-oriented Intervention Patients in Usual Care Partners in Usual Care
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%)   0/10 (0.00%)   0/10 (0.00%)   0/12 (0.00%)   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Patients in the Couple-oriented Intervention Partners in the Couple-oriented Intervention Patients in the Patient-oriented Intervention Partners in the Patient-oriented Intervention Patients in Usual Care Partners in Usual Care
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%)   0/10 (0.00%)   0/10 (0.00%)   0/12 (0.00%)   0/12 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Faith Luyster, PhD
Organization: University of Pittsburgh
Phone: 412-624-7910
EMail: fsl3@pitt.edu
Publications:
Responsible Party: Faith Luyster, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01377584     History of Changes
Other Study ID Numbers: 1K23HL105887-01A1 ( U.S. NIH Grant/Contract )
First Submitted: June 17, 2011
First Posted: June 21, 2011
Results First Submitted: July 12, 2017
Results First Posted: October 2, 2017
Last Update Posted: October 2, 2017