Increasing Motivation for Patient Adherence to CPAP Therapy (IMPACT)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2011 by University of Pittsburgh
Sponsor:
Collaborator:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01377584
First received: June 17, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Faith S Luyster, PhD University of Pittsburgh
  More Information

Publications:

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 September 15, 2014