COMMunication and Education for the New CPAP Experience (COMMENCE)

University of Pittsburgh

Status: Completed

Conditions: Sleep Apnea, Obstructive

Treatments: Other: No intervention; Device: Continuous positive airway pressure (CPAP); Behavioral: Couple-oriented intervention; Behavioral: Patient-oriented intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01377584

1K23HL105887-01A1

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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60 participants in 6 patient groups

Patients in the Couple-oriented intervention

Experimental group

Description:

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.

Treatment:

Device: Continuous positive airway pressure (CPAP)

Behavioral: Couple-oriented intervention

Patients in Usual Care

Other group

Description:

Patients will not attend any intervention sessions.

Treatment:

Device: Continuous positive airway pressure (CPAP)

Patients in the Patient-oriented intervention

Experimental group

Description:

Patients randomly assigned to the patient-oriented (PT) group will attend two face to face sessions and participate in a telephone follow-up session.

Treatment:

Device: Continuous positive airway pressure (CPAP)

Behavioral: Patient-oriented intervention

Partners in the Couple-oriented intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Couple-oriented intervention

Partners in Usual Care

Other group

Description:

Partners will not attend any intervention sessions.

Treatment:

Other: No intervention

Partners in the Patient-oriented intervention

Experimental group

Description:

Partners randomly assigned to the patient-oriented (PT) group will not attend any intervention sessions.

Treatment:

Behavioral: Patient-oriented intervention