COMMunication and Education for the New CPAP Experience

Not Applicable

Completed

• Conditions: Sleep Apnea, Obstructive
• Interventions: Device: Continuous positive airway pressure (CPAP); Behavioral: Patient-oriented intervention; Other: No intervention; Behavioral: Couple-oriented intervention

• Registration Number: NCT01377584
• Lead Sponsor: University of Pittsburgh

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2011-06-17
• Study First Submitted QC: 2011-06-17
• Study First Posted: 2011-06-21
• Study Start: 2014-03
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Results First Submitted: 2017-07-12
• Status Verified: 2017-09
• Results First Submitted QC: 2017-09-29
• Last Update Submitted: 2017-09-29
• Results First Posted: 2017-10-02
• Last Update Posted: 2017-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Patients in Usual Care	Continuous positive airway pressure (CPAP)	Patients will not attend any intervention sessions.
Patients in the Couple-oriented intervention	Continuous positive airway pressure (CPAP)	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.
Patients in the Patient-oriented intervention	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 in Usual Care	No intervention	Partners will not attend any intervention sessions.
Partners in the Patient-oriented intervention	Patient-oriented intervention	Partners randomly assigned to the patient-oriented (PT) group will not attend any intervention sessions.
Patients in the Couple-oriented intervention	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.
Patients in the Patient-oriented intervention	Continuous positive airway pressure (CPAP)	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 in the Couple-oriented intervention	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.

Primary Outcome Measures

Name	Time	Method
Daytime Sleepiness	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.
Sleep Quality	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.
Sleep-related Functional Outcomes	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.

Secondary Outcome Measures

Name	Time	Method
Continuous Positive Airway Pressure (CPAP) Adherence	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.

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States