COMMunication and Education for the New CPAP Experience

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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COMMENCE Study: COMMunication and Education for the New CPAP Experience

Conditions
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Sleep Apnea, Obstructive

Intervention / Treatment
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* Behavioral: Couple-oriented intervention
* Behavioral: Patient-oriented intervention
* Device: Continuous positive airway pressure (CPAP)
* Other: No intervention


Participation Criteria
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Eligibility Criteria
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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 Partner: 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, periodic limb movement disorder, insomnia) Diagnosis of a serious medical condition (e.g., end stage renal failure, severe chronic obstructive lung disease, severe asthma) History of or current diagnosis of a major psychiatric illness except depression (e.g., schizophrenia, bipolar disorder) partner: Have been diagnosed with OSA and using CPAP

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients in the Couple-oriented intervention<br>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<br>* 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.<br>Device: Continuous positive airway pressure (CPAP)<br>* CPAP is treatment for obstructive sleep apnea. CPAP therapy keeps the airway open during the night by providing a stream of air through a mask that is worn while sleeping.<br>|
| Other: Patients in Usual Care<br>Patients will not attend any intervention sessions. | Device: Continuous positive airway pressure (CPAP)<br>* CPAP is treatment for obstructive sleep apnea. CPAP therapy keeps the airway open during the night by providing a stream of air through a mask that is worn while sleeping.<br>|
| Experimental: Patients in the Patient-oriented intervention<br>Patients randomly assigned to the patient-oriented (PT) group will attend two face to face sessions and participate in a telephone follow-up session. | Behavioral: Patient-oriented intervention<br>* 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.<br>Device: Continuous positive airway pressure (CPAP)<br>* CPAP is treatment for obstructive sleep apnea. CPAP therapy keeps the airway open during the night by providing a stream of air through a mask that is worn while sleeping.<br>|
| Experimental: Partners in the Couple-oriented intervention<br>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. | Behavioral: Couple-oriented intervention<br>* 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.<br>|
| Other: Partners in Usual Care<br>Partners will not attend any intervention sessions. | Other: No intervention<br>* No intervention will be received.<br>|
| Experimental: Partners in the Patient-oriented intervention<br>Partners randomly assigned to the patient-oriented (PT) group will not attend any intervention sessions. | Behavioral: Patient-oriented intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daytime Sleepiness | 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. | baseline and 3 months after CPAP initiation | 
| Sleep-related Functional Outcomes | 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. | baseline and 3 months after CPAP initiation | 
| Sleep Quality | 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. | baseline and 3 months after CPAP initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuous Positive Airway Pressure (CPAP) Adherence | 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. | one week, one month, and 3 months after CPAP initiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spouses, Continuous Positive Airway Pressure, Patient Compliance, Intervention Studies