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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients in the Couple-oriented intervention | Experimental | 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 Usual Care | Other | Patients will not attend any intervention sessions. |
|
| Patients in the Patient-oriented intervention | Experimental | 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 | Experimental | 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. |
|
| Partners in Usual Care | Other |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Couple-oriented intervention | Behavioral | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Patient:
Partner:
Exclusion Criteria:
Patient:
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| Name | Affiliation | Role |
|---|---|---|
| Faith S Luyster, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15261 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18468310 | Background | Cartwright R. Sleeping together: a pilot study of the effects of shared sleeping on adherence to CPAP treatment in obstructive sleep apnea. J Clin Sleep Med. 2008 Apr 15;4(2):123-7. | |
| 10194151 | Background | Hoy CJ, Vennelle M, Kingshott RN, Engleman HM, Douglas NJ. Can intensive support improve continuous positive airway pressure use in patients with the sleep apnea/hypopnea syndrome? Am J Respir Crit Care Med. 1999 Apr;159(4 Pt 1):1096-100. doi: 10.1164/ajrccm.159.4.9808008. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | Partners in the Patient-oriented Intervention | Partners randomly assigned to the patient-oriented (PT) group will not attend any intervention sessions. |
| FG004 | Patients in Usual Care | Patients will not attend any intervention sessions. |
| FG005 | Partners in Usual Care | Partners will not attend any intervention sessions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | baseline and 3 months after CPAP initiation |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Faith Luyster, PhD | University of Pittsburgh | 412-624-7910 | fsl3@pitt.edu |
Not provided
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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Not provided
| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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Partners will not attend any intervention sessions.
|
| Partners in the Patient-oriented intervention | Experimental | Partners randomly assigned to the patient-oriented (PT) group will not attend any intervention sessions. |
|
|
| Patient-oriented intervention | Behavioral | 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. |
|
| Continuous positive airway pressure (CPAP) | Device | 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. |
|
| No intervention | Other | No intervention will be received. |
|
| one week, one month, and 3 months after CPAP initiation |
| 20549372 | Background | Baron KG, Smith TW, Berg CA, Czajkowski LA, Gunn H, Jones CR. Spousal involvement in CPAP adherence among patients with obstructive sleep apnea. Sleep Breath. 2011 Sep;15(3):525-34. doi: 10.1007/s11325-010-0374-z. Epub 2010 Jun 15. |
| 19116799 | Background | Baron KG, Smith TW, Czajkowski LA, Gunn HE, Jones CR. Relationship quality and CPAP adherence in patients with obstructive sleep apnea. Behav Sleep Med. 2009;7(1):22-36. doi: 10.1080/15402000802577751. |
| 17548722 | Background | Bazzano LA, Khan Z, Reynolds K, He J. Effect of nocturnal nasal continuous positive airway pressure on blood pressure in obstructive sleep apnea. Hypertension. 2007 Aug;50(2):417-23. doi: 10.1161/HYPERTENSIONAHA.106.085175. Epub 2007 Jun 4. |
| 16100147 | Background | Campos-Rodriguez F, Pena-Grinan N, Reyes-Nunez N, De la Cruz-Moron I, Perez-Ronchel J, De la Vega-Gallardo F, Fernandez-Palacin A. Mortality in obstructive sleep apnea-hypopnea patients treated with positive airway pressure. Chest. 2005 Aug;128(2):624-33. doi: 10.1378/chest.128.2.624. |
| 15600056 | Background | Aloia MS, Arnedt JT, Riggs RL, Hecht J, Borrelli B. Clinical management of poor adherence to CPAP: motivational enhancement. Behav Sleep Med. 2004;2(4):205-22. doi: 10.1207/s15402010bsm0204_3. |
| 20880872 | Background | Sparrow D, Aloia M, Demolles DA, Gottlieb DJ. A telemedicine intervention to improve adherence to continuous positive airway pressure: a randomised controlled trial. Thorax. 2010 Dec;65(12):1061-6. doi: 10.1136/thx.2009.133215. Epub 2010 Sep 29. |
| 11868136 | Background | Aloia MS, Di Dio L, Ilniczky N, Perlis ML, Greenblatt DW, Giles DE. Improving compliance with nasal CPAP and vigilance in older adults with OAHS. Sleep Breath. 2001;5(1):13-21. doi: 10.1007/s11325-001-0013-9. |
| 17564399 | Background | Aloia MS, Arnedt JT, Stepnowsky C, Hecht J, Borrelli B. Predicting treatment adherence in obstructive sleep apnea using principles of behavior change. J Clin Sleep Med. 2005 Oct 15;1(4):346-53. |
| 17680733 | Background | Aloia MS, Arnedt JT, Stanchina M, Millman RP. How early in treatment is PAP adherence established? Revisiting night-to-night variability. Behav Sleep Med. 2007;5(3):229-40. doi: 10.1080/15402000701264005. |
| 17580592 | Background | Weaver TE, Maislin G, Dinges DF, Bloxham T, George CF, Greenberg H, Kader G, Mahowald M, Younger J, Pack AI. Relationship between hours of CPAP use and achieving normal levels of sleepiness and daily functioning. Sleep. 2007 Jun;30(6):711-9. doi: 10.1093/sleep/30.6.711. |
| 9231953 | Background | Weaver TE, Kribbs NB, Pack AI, Kline LR, Chugh DK, Maislin G, Smith PL, Schwartz AR, Schubert NM, Gillen KA, Dinges DF. Night-to-night variability in CPAP use over the first three months of treatment. Sleep. 1997 Apr;20(4):278-83. doi: 10.1093/sleep/20.4.278. |
| 17967089 | Background | Berg CA, Upchurch R. A developmental-contextual model of couples coping with chronic illness across the adult life span. Psychol Bull. 2007 Nov;133(6):920-54. doi: 10.1037/0033-2909.133.6.920. |
| 8202884 | Background | Engleman HM, Martin SE, Douglas NJ. Compliance with CPAP therapy in patients with the sleep apnoea/hypopnoea syndrome. Thorax. 1994 Mar;49(3):263-6. doi: 10.1136/thx.49.3.263. |
| 1798888 | Background | Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540. |
| 9415942 | Background | Weaver TE, Laizner AM, Evans LK, Maislin G, Chugh DK, Lyon K, Smith PL, Schwartz AR, Redline S, Pack AI, Dinges DF. An instrument to measure functional status outcomes for disorders of excessive sleepiness. Sleep. 1997 Oct;20(10):835-43. |
| 14592213 | Background | Stepnowsky CJ Jr, Marler MR, Ancoli-Israel S. Determinants of nasal CPAP compliance. Sleep Med. 2002 May;3(3):239-47. doi: 10.1016/s1389-9457(01)00162-9. |
| 3945130 | Background | Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986 Jan;24(1):67-74. doi: 10.1097/00005650-198601000-00007. |
| 1774625 | Background | Pierce GR, Sarason IG, Sarason BR. General and relationship-based perceptions of social support: are two constructs better than one? J Pers Soc Psychol. 1991 Dec;61(6):1028-39. doi: 10.1037//0022-3514.61.6.1028. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Partners in the Patient-oriented Intervention | Partners randomly assigned to the patient-oriented (PT) group will not attend any intervention sessions. |
| BG004 | Patients in Usual Care | Patients will not attend any intervention sessions. |
| BG005 | Partners in Usual Care | Partners will not attend any intervention sessions |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Apnea-Hypopnea Index | Apnea-Hypopnea Index is a measure of the total number of apnea and hypopnea events per hour of sleep. | Mean | Standard Deviation | Events per hour of sleep |
|
| OG001 | 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. |
| OG002 | 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. |
| OG003 | Partners in the Patient-oriented Intervention | Partners randomly assigned to the patient-oriented (PT) group will not attend any intervention sessions. |
| OG004 | Patients in Usual Care | Patients will not attend any intervention sessions. |
| OG005 | Partners in Usual Care | Partners will not attend any intervention sessions. |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | baseline and 3 months after CPAP initiation |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | baseline and 3 months after CPAP initiation |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | hours of use | one week, one month, and 3 months after CPAP initiation |
|
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | 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 | 0 | 8 | 0 | 8 | 0 | 8 |
| EG002 | 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. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG003 | Partners in the Patient-oriented Intervention | Partners randomly assigned to the patient-oriented (PT) group will not attend any intervention sessions. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG004 | Patients in Usual Care | Patients will not attend any intervention sessions. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG005 | Partners in Usual Care | Partners will not attend any intervention sessions. | 0 | 12 | 0 | 12 | 0 | 12 |
Not provided
Not provided
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D012138 |
| Respiratory Therapy |
| 3 month follow-up |
|
| Change from Baseline to 3 months |
|
| 0.41 |
| 2-Sided |
| Other |
| Effect size | 0.57 | 2-Sided | Other |
| Effect size | 1.54 | 2-Sided | Other |
| Effect size | 0.00 | 2-Sided | Other |
| Effect size | 0.65 | 2-Sided | Other |
| 3 month follow-up |
|
| Change from Baseline to 3 months |
|
| -0.94 |
| 2-Sided |
| Other |
| Effect size | -0.40 | 2-Sided | Other |
| Effect size | -0.31 | 2-Sided | Other |
| Effect size | -0.65 | 2-Sided | Other |
| Effect size | -0.77 | 2-Sided | Other |
|
| Change from 1 week to 1 month |
|
| 3 months |
|
| Change from 1 month to 3 months |
|
| Effect size |
| -0.63 |
| 2-Sided |
Comparing 1 month and 3 months |
| Other |
| Effect size | 0.50 | 2-Sided | Comparing 1 week to 1 month | Other |
| Effect size | -0.63 | 2-Sided | Comparing 1 month to 3 months | Other |
| Effect size | -0.92 | 2-Sided | Comparing 1 week to 1 month | Other |
| Effect size | -0.26 | 2-Sided | Comparing 1 month to 3 months | Other |