COMMunication and Education for the New CPAP Experience

NCT01377584 | Completed Results

• 1 other identifier: 1K23HL105887-01A1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Sleep Apnea, Obstructive

Keywords

Continuous Positive Airway Pressure; Patient Compliance; Intervention Studies; Spouses

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Continuous Positive Airway Pressure (CPAP) Adherence

  one week, one month, and 3 months after CPAP initiation

Study Arms (6)

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.

Behavioral: Couple-oriented intervention; Device: Continuous positive airway pressure (CPAP)

Patients in Usual Care

OTHER

Patients will not attend any intervention sessions.

Device: Continuous positive airway pressure (CPAP)

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.

Behavioral: Patient-oriented intervention; Device: Continuous positive airway pressure (CPAP)

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.

Behavioral: Couple-oriented intervention

Partners in Usual Care

OTHER

Partners will not attend any intervention sessions.

Other: No intervention

Partners in the Patient-oriented intervention

EXPERIMENTAL

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

Behavioral: Patient-oriented intervention

Interventions

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.

Partners in the Couple-oriented intervention; Patients in the Couple-oriented intervention

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.

Partners in the Patient-oriented intervention; Patients in the Patient-oriented intervention

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.

Patients in Usual Care; Patients in the Couple-oriented intervention; Patients in the Patient-oriented intervention

No intervention OTHER

No intervention will be received.

Partners in Usual Care

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

Related Publications (20)

• 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.

  PMID: 18468310 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.

  PMID: 10194151 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.

  PMID: 20549372 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.

  PMID: 19116799 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.

  PMID: 17548722 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.

  PMID: 16100147 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.

  PMID: 15600056 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.

  PMID: 20880872 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.

  PMID: 11868136 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.

  PMID: 17564399 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.

  PMID: 17680733 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.

  PMID: 17580592 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.

  PMID: 9231953 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.

  PMID: 17967089 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.

  PMID: 8202884 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.

  PMID: 1798888 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.

  PMID: 9415942 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.

  PMID: 14592213 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.

  PMID: 3945130 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.

  PMID: 1774625 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Patient Compliance

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Results Point of Contact

• Title: Faith Luyster, PhD
• Organization: University of Pittsburgh

fsl3@pitt.edu

412-624-7910

Study Officials

• Faith S Luyster, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 17, 2011
• First Posted: June 21, 2011
• Study Start: March 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: October 2, 2017
• Results First Posted: October 2, 2017

Record last verified: 2017-09

Locations

US (1)