Tailored Intervention to Promote Positive Airway Pressure Adherence (SCIP-PA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01454830
Recruitment Status : Completed
First Posted : October 19, 2011
Results First Posted : November 23, 2016
Last Update Posted : November 23, 2016
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Amy M. Sawyer, Milton S. Hershey Medical Center

Brief Summary:
The purpose of this study is to examine the feasibility of a tailored (i.e., individualized) intervention to promote adherence to continuous positive airway pressure therapy (CPAP) in adults with newly-diagnosed, CPAP treated, obstructive sleep apnea.

Condition or disease Intervention/treatment Phase
Sleep Apnea, Obstructive Patient Compliance Behavioral: Tailored Other: Usual care Phase 1

Detailed Description:
Poor adherence to CPAP is a significant problem among OSA patients resulting in suboptimal health and functional outcomes. Intervention studies to promote CPAP adherence have shown relatively small effects in selected samples and were costly. The overall objective of this research is to examine the effect, feasibility, and acceptability of a tailored intervention on CPAP adherence among adults with newly-diagnosed, CPAP treated OSA. The central hypothesis is that critically timed tailored interventions that focus on sociocultural aspects and cognitive perceptions of the individual experience with OSA diagnosis and treatment will improve overall CPAP adherence rates. The pilot randomized controlled trial will examine CPAP adherence outcomes at 1wk, 1mo, and 3mo among those randomly assigned to the tailored intervention or usual (standard) care and examine specific feasibility and participant acceptability outcomes in order to design and conduct a subsequent larger randomized controlled trial testing the overall efficacy of the tailored intervention.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase I Double-blind Randomized Controlled Trial: Sociocultural and Cognitive Perception Intervention to Promote Positive Airway Pressure Adherence
Study Start Date : November 2011
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Arm Intervention/treatment
Experimental: Tailored
Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions
Behavioral: Tailored
Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy
Other Name: Individualized

Active Comparator: Usual care
The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment
Other: Usual care
Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care
Other Name: standard of care

Primary Outcome Measures :
  1. Nightly CPAP Use [ Time Frame: 1 week ]
    Mean CPAP use, hrs/night

  2. Nightly CPAP Use [ Time Frame: 1 month ]
    Mean CPAP use, hrs/night

  3. Nightly CPAP Use [ Time Frame: 3 months ]
    Mean CPAP use, hrs/night

Secondary Outcome Measures :
  1. Proportion of Sleep Time on CPAP [ Time Frame: 1 week ]
    % of Total Sleep Time (TST) using CPAP

  2. Proportion of Participants Who Complete Protocol After Allocation [ Time Frame: Duration of protocol period ]
    Feasibility assessment - retention after enrollment and allocation employed as a feasibility outcome of pilot RCT

  3. Proportion of Participants Who Withdrawal [ Time Frame: Duration of protocol period ]
    Feasibility assessment - withdrawal by participants for feasibility outcome of pilot RCT

  4. Acceptability of Study Intervention and Comparative Group [ Time Frame: 3 months ]
    Feasibility assessment to determine participant acceptance of the study intervention and comparative condition (i.e., usual care); semi-structured interviews conducted with 50% of participants randomly assigned to "interview" at study termination and debriefing (3 months)

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • males and females >/= 18 years of age
  • newly diagnosed with apnea/hypopnea index >/= 10 events/hr
  • CPAP naive
  • able to read and speak English

Exclusion Criteria:

  • previous diagnosis and/or treatment of OSA
  • major new psychiatric diagnosis within 6 months of study enrollment
  • require supplemental oxygen or bilevel positive airway pressure on CPAP titration polysomnogram
  • diagnosis of co-existent sleep disorder on polysomnogram, including periodic limb movements >/= 10 events/hr with arousal, central sleep apnea with >/= 5 central events/hr, insomnia, sleep hypoventilation syndrome, or narcolepsy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01454830

United States, Pennsylvania
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
National Institute of Nursing Research (NINR)
Principal Investigator: Amy M Sawyer, PhD The Pennsylvania State University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Amy M. Sawyer, Assistant Professor, Milton S. Hershey Medical Center Identifier: NCT01454830     History of Changes
Other Study ID Numbers: 37007
4R00NR011173 ( U.S. NIH Grant/Contract )
First Posted: October 19, 2011    Key Record Dates
Results First Posted: November 23, 2016
Last Update Posted: November 23, 2016
Last Verified: September 2016

Keywords provided by Amy M. Sawyer, Milton S. Hershey Medical Center:
Social support
Adaptation, psychological
Health behavior
Patient education

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases