Increasing Motivation for Patient Adherence to CPAP Therapy - Full Text View

Purpose

The purpose of this research study is to modify a brief motivational intervention by incorporating significant others (SO) into the intervention sessions and beginning the intervention before continuous positive airway pressure (CPAP) initiation and to determine if this modified motivational intervention will improve CPAP adherence in patients with obstructive sleep apnea.

Condition	Intervention	Phase
Sleep Apnea, Obstructive	Behavioral: modified ME intervention Behavioral: Education Only	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	Enhancing Motivation for CPAP Adherence in Obstructive Sleep Apnea

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

Continuous Positive Airway Pressure (CPAP) adherence [ Time Frame: one week and 3 months after CPAP initiation ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Daytime sleepiness [ Time Frame: baseline and 3 months after CPAP initiation ] [ Designated as safety issue: No ]
The Epworth Sleepiness Scale is an 8-item questionnaire that assesses daytime sleepiness.
Sleep-related functional outcomes [ Time Frame: baseline and 3 months after CPAP initiation ] [ Designated as safety issue: No ]
The Functional Outcomes of Sleep Questionnaire is 30-item questionnaire assesses the impact of sleep disorders of excessive sleepiness on multiple activities of everyday living. A total score and scores for five factors of functioning (e.g., activity, vigilance, intimacy and sexual relationships, general productivity, and social outcome) are obtained.
Blood Pressure [ Time Frame: baseline and 3 months after CPAP initiation ] [ Designated as safety issue: No ]
Blood pressure assessment will be taken according to American Heart Association (AHA) guidelines. After a 5-minute rest period, three blood pressures will be taken 1-2 minutes apart in a sitting position and the average of last two will be recorded. Both systolic and diastolic values will be used.
Self-reported medication adherence [ Time Frame: baseline and 3 months after CPAP initiation ] [ Designated as safety issue: No ]
Self-reported medication adherence will be assessed using the Morisky Medication Adherence Scale, a structured 4-item self-reported adherence measure. Respondents answer "yes" or "no" to each item. A score of 1 is given for "no" and a 0 for "yes". Scores range from 0 to 4, with 4 indicating high adherence.
Relationship quality [ Time Frame: baseline and 3 months after CPAP initiation ] [ Designated as safety issue: No ]
Relationship quality will be assessed by the Quality of Relationship Inventory support and conflict scales. Both patients and significant others will complete this questionnaire.
Motivation [ Time Frame: during each modified ME intervention session ] [ Designated as safety issue: No ]
Measures of readiness, importance, and confidence will be obtained using a previously validated 22-item questionnaire. The readiness ladder consists of 6 items designed to describe each 1 of the 6 stages of change as proposed by Prochaska and DiClemente. The decisional balance measure assesses the pros and cons of engaging in a particular behavior and each item is rated on a 5-point Likert scale. The self-efficacy scale was constructed using statements to assess the extent to which the patients believe that they can do the required tasks.

Estimated Enrollment:	120
Study Start Date:	July 2013
Estimated Study Completion Date:	July 2016
Estimated Primary Completion Date:	July 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Education Only Patients in the Education Only (EO) group will receive the same amount of face-to-face and telephone contact (i.e., two 45-minute sessions, 1 20-minute follow-up phone call) by any two interventionists trained by the PI in the EO intervention. Patients' SOs will attend the two education sessions and follow-up phone call. Treatment will provide educational information on normal human sleep and OSA. The following information will be presented in session 1 of the EO intervention: overview of sleep stages, human circadian rhythms, sleep and aging, and daytime sleepiness. Session 2 will include: pathophysiology, signs, symptoms, and consequences of OSA and treatment options. The follow-up phone call will consist of a review of the information presented in session 1 and 2.	Behavioral: Education Only Patients in the Education Only (EO) group will receive the same amount of face-to-face and telephone contact (i.e., two 45-minute sessions, 1 20-minute follow-up phone call) by any two interventionists trained by the PI in the EO intervention. Patients' SOs will attend the two education sessions and follow-up phone call. Treatment will provide educational information on normal human sleep and OSA. The following information will be presented in session 1 of the EO intervention: overview of sleep stages, human circadian rhythms, sleep and aging, and daytime sleepiness. Session 2 will include: pathophysiology, signs, symptoms, and consequences of OSA and treatment options. The follow-up phone call will consist of a review of the information presented in session 1 and 2.
No Intervention: Standard Care A research assistant will contact patients in the SC group to discuss their randomization assignment and schedule their baseline assessment. The SC group will receive clinical care provided at the UPMC Sleep Medicine Center. This care includes the diagnostic procedures described above, a routine follow-up visit to discuss treatment options, a CPAP titration night, a routine follow-up physician visit, and subsequent visits if necessary or requested by the patient.
Experimental: modified ME intervention The modified motivational enhancement (ME) intervention includes two 45-minute face-to-face sessions, 1 week apart, and a follow-up phone call a week later with both patient and SO. The follow-up phone call will be conducted 1 week after the final counseling session and last approximately 20 minutes. It will consist of a review of treatment goals and a continuation of ME techniques by exploring barriers to change and benefits of changing.	Behavioral: modified ME intervention The modified motivational enhancement (ME) intervention includes two 45-minute face-to-face sessions, 1 week apart, and a follow-up phone call a week later with both patient and SO. The follow-up phone call will be conducted 1 week after the final counseling session and last approximately 20 minutes. It will consist of a review of treatment goals and a continuation of ME techniques by exploring barriers to change and benefits of changing.

Detailed Description:

Continuous positive airway pressure (CPAP) therapy is an effective treatment for obstructive sleep apnea (OSA), but adherence is poor. Motivational enhancement (ME) therapy is the most promising approach, to date, for improving adherence to CPAP, but the intervention 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 CPAP and are frequently described as the greatest source of social support for patients with chronic illness. Beginning the intervention before CPAP initiation would capitalize on the teachable moment shortly following diagnosis when motivation and social support may be most essential. The primary aim is to conduct a randomized controlled pilot study to examine the effects of a modified motivational intervention on CPAP adherence and the relationship between CPAP adherence and health outcomes (e.g., daytime sleepiness, sleep-related functional status, self-reported medication adherence, and blood pressure). Patients in the pilot study will be randomized to the intervention, attention control, or standard clinical care group.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient:

Age is 21 years of age and older
Have spouse or partner
Have speakerphone capabilities or two phones connected to the same landline
Polysomnographically (PSG) diagnosed OSA (AHI ≥ 5)
Choice of continuous positive airway pressure (CPAP) as preferred treatment

Significant Other:

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
Have speakerphone capabilities or two phones connected to the same landline

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, PLMD, insomnia)
Diagnosis of a serious medical condition (e.g., end stage renal failure, severe COPD, severe asthma)
History of or current diagnosis of a major psychiatric illness except depression (e.g., schizophrenia, bipolar disorder)

Significant Other:

Have been diagnosed with OSA and using CPAP

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01377584

Contacts

Contact: Faith S Luyster, PhD

412-624-7910

luysterfs@upmc.edu

Locations

United States, Pennsylvania
University of Pittsburgh	Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15261
Contact: Faith S Luyster, PhD 412-624-7910 luysterfs@upmc.edu
Principal Investigator: Faith S Luyster, PhD

Sponsors and Collaborators

University of Pittsburgh

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator:

Faith S Luyster, PhD

University of Pittsburgh

More Information

Publications:

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.

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.

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. 2010 Jun 15; [Epub ahead of print]

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.

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. Epub 2007 Jun 4. Review.

Campos-Rodriguez F, Peña-Griñan N, Reyes-Nuñez 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.

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.

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. Epub 2010 Sep 29.

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.

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.

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.

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.

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.

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. Review.

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.

Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5.

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.

Pickering TG, Hall JE, Appel L, Falkner B, Graves J, Hill M, Jones DW, Kurtz T, Sheps S, Roccella E. Response to Recommendations for Blood Pressure Measurement in Human and Experimental Animals; Part 1: Blood Pressure Measurement in Humans and Miscuffing: A Problem With New Guidelines: Addendum. Hypertension. 2006 Jun 12; [Epub ahead of print] No abstract available.

Stepnowsky CJ Jr, Marler MR, Ancoli-Israel S. Determinants of nasal CPAP compliance. Sleep Med. 2002 May;3(3):239-47.

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.

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.

Responsible Party:	Faith S Luyster, University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT01377584 History of Changes
Other Study ID Numbers:	1K23HL105887-01A1
Study First Received:	June 17, 2011
Last Updated:	June 17, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

Continuous Positive Airway Pressure
Patient Compliance
Motivation
Intervention Studies
Spouses

Additional relevant MeSH terms:

Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory

Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on June 17, 2013

Increasing Motivation for Patient Adherence to CPAP Therapy (IMPACT)