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Completed

NCT Number: NCT01454830

Tailored 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.

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Key information

Conditions

Sleep Apnea, Obstructive Apnea Behavior Dyssomnias Health Behavior Nervous System Diseases Patient Acceptance of Health Care Patient Compliance Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tailored

Behavioral

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 names: Individualized

Usual Care

Other

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 names: standard of care

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Collaborators

  • ANF
  • National Institute of Nursing Research (NINR)

Registry information

Official study title

Phase I Double-blind Randomized Controlled Trial: Sociocultural and Cognitive Perception Intervention to Promote Positive Airway Pressure Adherence

Acronym: SCIP-PA

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Oct 19, 2011
Registry last updated
Nov 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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