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Tailored Intervention to Promote Positive Airway Pressure Adherence

NCT ID: NCT01454830

Last Updated: 2016-11-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2014-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sleep Apnea, Obstructive Patient Compliance

Keywords

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Social support Cognition Adaptation, psychological Health behavior Patient education

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Tailored

Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions

Group Type EXPERIMENTAL

Tailored

Intervention Type 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

Usual care

The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type 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

Interventions

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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

Intervention Type BEHAVIORAL

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

Intervention Type OTHER

Other Intervention Names

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Individualized standard of care

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

ANF

UNKNOWN

Sponsor Role collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Amy M. Sawyer

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amy M Sawyer, PhD

Role: PRINCIPAL_INVESTIGATOR

The Pennsylvania State University

Locations

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Penn State Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Countries

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United States

References

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Sawyer AM, Deatrick JA, Kuna ST, Weaver TE. Differences in perceptions of the diagnosis and treatment of obstructive sleep apnea and continuous positive airway pressure therapy among adherers and nonadherers. Qual Health Res. 2010 Jul;20(7):873-92. doi: 10.1177/1049732310365502. Epub 2010 Mar 30.

Reference Type BACKGROUND
PMID: 20354236 (View on PubMed)

Sawyer AM, Canamucio A, Moriarty H, Weaver TE, Richards KC, Kuna ST. Do cognitive perceptions influence CPAP use? Patient Educ Couns. 2011 Oct;85(1):85-91. doi: 10.1016/j.pec.2010.10.014. Epub 2010 Nov 10.

Reference Type BACKGROUND
PMID: 21071166 (View on PubMed)

Sawyer AM, Gooneratne NS, Marcus CL, Ofer D, Richards KC, Weaver TE. A systematic review of CPAP adherence across age groups: clinical and empiric insights for developing CPAP adherence interventions. Sleep Med Rev. 2011 Dec;15(6):343-56. doi: 10.1016/j.smrv.2011.01.003. Epub 2011 Jun 8.

Reference Type BACKGROUND
PMID: 21652236 (View on PubMed)

Weaver TE, Maislin G, Dinges DF, Younger J, Cantor C, McCloskey S, Pack AI. Self-efficacy in sleep apnea: instrument development and patient perceptions of obstructive sleep apnea risk, treatment benefit, and volition to use continuous positive airway pressure. Sleep. 2003 Sep;26(6):727-32. doi: 10.1093/sleep/26.6.727.

Reference Type BACKGROUND
PMID: 14572127 (View on PubMed)

Yang H, Watach A, Varrasse M, King TS, Sawyer AM. Clinical Trial Enrollment Enrichment in Resource-Constrained Research Environments: Multivariable Apnea Prediction (MAP) Index in SCIP-PA Trial. J Clin Sleep Med. 2018 Feb 15;14(2):173-181. doi: 10.5664/jcsm.6926.

Reference Type DERIVED
PMID: 29246264 (View on PubMed)

Other Identifiers

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4R00NR011173

Identifier Type: NIH

Identifier Source: secondary_id

View Link

37007

Identifier Type: -

Identifier Source: org_study_id