Clinical trial NCT01454830: Tailored Intervention to Promote Positive Airway Pressure Adherence
Official title: Phase I Double-blind Randomized Controlled Trial: Sociocultural and Cognitive Perception Intervention to Promote Positive Airway Pressure Adherence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sleep Apnea, Obstructive
Patient Compliance
Keywords: Social support
Cognition
Adaptation, psychological
Health behavior
Patient education
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
name: ANF
First posted: 2011-10-19
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Nightly CPAP Use
timeFrame: 1 week
measure: Nightly CPAP Use
timeFrame: 1 month
measure: Nightly CPAP Use
timeFrame: 3 months
Secondary outcomes:
measure: Proportion of Sleep Time on CPAP
timeFrame: 1 week
measure: Proportion of Participants Who Complete Protocol After Allocation
timeFrame: Duration of protocol period
measure: Proportion of Participants Who Withdrawal
timeFrame: Duration of protocol period
measure: Acceptability of Study Intervention and Comparative Group
timeFrame: 3 months
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: The Pennsylvania State University
name: Amy M Sawyer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.