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
  Purpose

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 Intervention Phase
Sleep Apnea, Obstructive
Patient Compliance
Behavioral: Tailored
Other: Usual care
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 72
Study Start Date: November 2011
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01454830

Locations
United States, Pennsylvania
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Sigma Theta Tau International
Investigators
Principal Investigator: Amy M Sawyer, PhD The Pennsylvania State University
  More Information

Publications:
Responsible Party: Amy M. Sawyer, Assistant Professor, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01454830     History of Changes
Other Study ID Numbers: 37007, 4R00NR011173
Study First Received: October 12, 2011
Last Updated: December 29, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 22, 2014