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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    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
STARTED   8   8   10   10   12   12 
COMPLETED   5   5   6   6   9   9 
NOT COMPLETED   3   3   4   4   3   3 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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
Total Total of all reporting groups

Baseline Measures
   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 
Overall Participants Analyzed 
[Units: Participants]
 5   5   6   6   9   9   40 
Age 
[Units: Years]
Mean (Standard Deviation)
 49  (14)   43  (3)   50  (11)   54  (14)   54  (7)   54  (7)   52  (10) 
Sex: Female, Male 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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] [2] 
[Units: Events per hour of sleep]
Mean (Standard Deviation)
 40  (40)   NA [2]   30  (32)   NA [2]   40  (28)   NA [2]   37  (31) 
[1] 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.


  Outcome Measures

1.  Primary:   Daytime Sleepiness   [ Time Frame: baseline and 3 months after CPAP initiation ]

2.  Primary:   Sleep-related Functional Outcomes   [ Time Frame: baseline and 3 months after CPAP initiation ]

3.  Primary:   Sleep Quality   [ Time Frame: baseline and 3 months after CPAP initiation ]

4.  Secondary:   Continuous Positive Airway Pressure (CPAP) Adherence   [ Time Frame: one week, one month, and 3 months after CPAP initiation ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: 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