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

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.

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

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

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 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

Feasibility assessment - retention after enrollment and allocation employed as a feasibility outcome of pilot RCT

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)

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

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.

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.

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.

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.

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.