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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Sigma Theta Tau International
Information provided by (Responsible Party):
Amy M. Sawyer, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01454830
First received: October 12, 2011
Last updated: December 29, 2013
Last verified: December 2013

October 12, 2011
December 29, 2013
November 2011
February 2014   (final data collection date for primary outcome measure)
  • Nightly CPAP use [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Mean CPAP use, hrs/night
  • Nightly CPAP use [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Mean CPAP use, hrs/night
  • Nightly CPAP use [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Mean CPAP use, hrs/night
Same as current
Complete list of historical versions of study NCT01454830 on ClinicalTrials.gov Archive Site
  • Proportion of sleep time on CPAP [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    % of Total Sleep Time (TST) using CPAP
  • Proportion of patients enrolled after positive screening [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Feasibility assessment
  • Proportion of participants complete protocol [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Feasibility assessment
  • Proportion of participants who withdrawal [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Feasibility assessment
  • Study personnel training costs [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Feasibility assessment aimed at projecting budget requirements for subsequent larger trial
  • Acceptability of study intervention and comparative group [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 debriefing (3 months)
  • Proportion of sleep time using CPAP [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    % of total sleep time (TST) using CPAP
  • Proportion of sleep time using CPAP [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    % of total sleep time (TST) using CPAP
Same as current
Not Provided
Not Provided
 
Tailored Intervention to Promote Positive Airway Pressure Adherence
Phase I Double-blind Randomized Controlled Trial: Sociocultural and Cognitive Perception Intervention to Promote Positive Airway Pressure Adherence

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Sleep Apnea, Obstructive
  • Patient Compliance
  • 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
  • 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
  • Experimental: Tailored
    Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions
    Intervention: Behavioral: Tailored
  • 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
    Intervention: Other: Usual care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
72
February 2014
February 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01454830
37007, 4R00NR011173
No
Amy M. Sawyer, Milton S. Hershey Medical Center
Milton S. Hershey Medical Center
  • National Institute of Nursing Research (NINR)
  • Sigma Theta Tau International
Principal Investigator: Amy M Sawyer, PhD The Pennsylvania State University
Milton S. Hershey Medical Center
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP