COMMunication and Education for the New CPAP Experience (COMMENCE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by University of Pittsburgh
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01377584
First received: June 17, 2011
Last updated: December 2, 2014
Last verified: December 2014
  Purpose

The purpose of this research study is to examine the effect of a couple-oriented education and support intervention on patient- and partner -reported outcomes (positive airway pressure (PAP) adherence) in patients newly diagnosed with obstructive sleep apnea (OSA).


Condition Intervention Phase
Sleep Apnea, Obstructive
Behavioral: Couple-oriented intervention
Behavioral: Patient-oriented intervention
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: COMMENCE Study: COMMunication and Education for the New CPAP Experience

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Daytime sleepiness [ Time Frame: baseline and 3 months after CPAP initiation ] [ Designated as safety issue: No ]
    The Epworth Sleepiness Scale is an 8-item questionnaire that assesses daytime sleepiness.

  • Sleep-related functional outcomes [ Time Frame: baseline and 3 months after CPAP initiation ] [ Designated as safety issue: No ]
    The Functional Outcomes of Sleep Questionnaire is 30-item questionnaire assesses the impact of sleep disorders of excessive sleepiness on multiple activities of everyday living. A total score and scores for five factors of functioning (e.g., activity, vigilance, intimacy and sexual relationships, general productivity, and social outcome) are obtained.

  • Sleep quality [ Time Frame: baseline and 3 months after CPAP initiation ] [ Designated as safety issue: No ]
    The Pittsburgh Sleep Quality Index 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.


Secondary Outcome Measures:
  • Continuous Positive Airway Pressure (CPAP) adherence [ Time Frame: one week and 3 months after CPAP initiation ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 60
Study Start Date: March 2014
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Couple-oriented intervention
Patients randomly assigned to the couple-oriented (CO) group will attend two face to face sessions with their partner and participate in an individual telephone follow-up session.
Behavioral: Couple-oriented intervention
The first session will occur before the patient receives his/her CPAP and will last approximately 2 hours. This session will provide the couple with education on sleep apnea and CPAP and information on different types of PAP therapy and cleaning procedures, 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 and will last approximately one and a half hours. 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 and will last approximately 20 minutes. This session will review CPAP usage and explore barriers and facilitators of CPAP use.
No Intervention: Usual Care
Neither patients nor their partners will attend any intervention sessions.
Experimental: 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. Partners will not attend any intervention sessions.
Behavioral: Patient-oriented intervention
The first session will occur before the patient receives his/her CPAP and will last approximately one and a half hours. This session will provide the patient with education on sleep apnea and CPAP and information on different types of PAP therapy and cleaning procedures, 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 and will last approximately 45 minutes. The second session will provide 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 session will occur two weeks after the patient has received his/her CPAP and will last approximately 20 minutes. This session will review CPAP usage and explore barriers and facilitators of CPAP use.

Detailed Description:

Continuous positive airway pressure (CPAP) therapy is an effective treatment for obstructive sleep apnea (OSA), but adherence is poor. CPAP adherence interventions to date have been met with limited success. Intervention strategies would be optimized by added support for patients and alternative strategies for intervention delivery. Significant others (SO) are likely to exert positive and negative effects on the patient's adoption and use of positive airway pressure (PAP) therapy and are frequently described as the greatest source of social support for patients with chronic illness. Beginning the intervention before PAP initiation would capitalize on the teachable moment shortly following diagnosis when education and social support may be most essential. The aims of the research plan are to examine the effects of a couple-oriented education and support intervention on patient- and partner-reported outcomes as compared to a patient-oriented education and support intervention and usual care and to examine the relationship between PAP adherence and patients' and partners' sleep quality and daytime functioning. Patients in the pilot study will be randomized to the couple-oriented intervention, patient-oriented intervention, or standard clinical care group.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patient:

  • Age is 21 years of age and older
  • Have spouse or partner
  • Polysomnographically (PSG) diagnosed OSA (AHI ≥ 5)
  • Choice of continuous positive airway pressure (CPAP) as preferred treatment

Significant Other:

  • Age is 18 years of age and older
  • Have spouse or partner who has been diagnosed with OSA and has chosen CPAP as preferred treatment

Exclusion Criteria:

Patient:

  • AHI < 5 on the diagnostic PSG
  • Have a spouse or partner with OSA diagnosis and on OSA treatment
  • Past treatment for OSA
  • Diagnosis of a sleep disorder other than OSA that cause arousals from sleep (e.g., central sleep apnea, PLMD, insomnia)
  • Diagnosis of a serious medical condition (e.g., end stage renal failure, severe COPD, severe asthma)
  • History of or current diagnosis of a major psychiatric illness except depression (e.g., schizophrenia, bipolar disorder)

Significant Other:

  • Have been diagnosed with OSA and using CPAP
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01377584

Contacts
Contact: Faith S Luyster, PhD 412-624-7910 luysterfs@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15261
Contact: Faith S Luyster, PhD    412-624-7910    luysterfs@upmc.edu   
Principal Investigator: Faith S Luyster, PhD         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Faith S Luyster, PhD University of Pittsburgh
  More Information

Publications:

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01377584     History of Changes
Other Study ID Numbers: 1K23HL105887-01A1
Study First Received: June 17, 2011
Last Updated: December 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Continuous Positive Airway Pressure
Patient Compliance
Intervention Studies
Spouses

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Apnea
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Sleep Apnea Syndromes
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on August 30, 2015