1. Complex Tailored Intervention Pilot Randomized Controlled Trial: Social Cognitive Intervention to Promote Positive Airway Pressure (PAP) Adherence -- The SCIP-PA Trial.
- Author
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Sawyer, Amy M., Sawyer, Douglas A., King, Tonya S., Weaver, Terri E., Varrasse, Miranda, Franks, Jamie, Watach, Alexa, Kolanowski, Ann, and Richards, Kathy C.
- Subjects
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CONFERENCES & conventions , *MEDICAL quality control , *NURSING , *NURSING research - Abstract
Background/Purpose: Improving PAP treatment adherence is imperative to reducing OSA health risks. We pilot tested a complex, tailored intervention to determine (1) intervention effect size for PAP adherence at 1-week (primary), 1-month (mos), and 3-mos; and (2) intervention feasibility/acceptability. Theoretical Framework: Social cognitive theory guided tailored intervention design and selection of tailoring critical indicator. Methods: Randomized, double-blind, pilot controlled trial with a convenience sample of adults referred to polysomnography (PSG) with inclusion criteria: (1) OSA with apnea hypopnea index (AHI) > 10 events/hour; (2) PAP-naive; (3) adults ≥ 18 years. Exclusion criteria: (1) prior OSA diagnosis/treatment; (2) EMR-documented new psychiatric diagnosis within 6-mos of enrollment; (3) oxygen or bi-level positive airway pressure; (4) PSG diagnosis of secondary sleep disorder. Adults (n=118) were randomized to tailored intervention (TI; n=61) or usual care (UC; n=57). After randomization, participants were excluded per criteria (TI, n=31; UC, n=27) resulting in complete exposure/data (n=30 per group). Middle-aged (mean 51.3 yrs) adults (70% male) with severe OSA (mean AHI 35.9 events/hour) participated. A complex tailored intervention, targeting social cognitive perceptions of OSA and PAP treatment, was delivered at OSA diagnosis, first exposure to PAP, and during first week home PAP use. A critical indicator guided intervention tailoring. Outcomes: objective PAP use; per-protocol intervention fidelity; participant acceptability of exposure condition. Descriptive analysis, effect size, group differences and change scores by t-test, and thematic analysis of acceptability data are reported. Results: 1-week PAP use for TI group was 35 minutes greater than for UC group (p=0.20; Cohen's d effect size 0.336). PAP use attenuation was observed for both groups at 1-mos and 3-mos (NS). Per-protocol delivery of face-to-face intervention activities was 100%; per-protocol delivery of telephone intervention activities was lower (PAP treatment Day 2 fidelity= 43.3%; Day 7 fidelity= 23.3%). Personalized approach to OSA diag-nosis/PAP treatment was highly valued. Conclusions/Implications: A tailored intervention to promote PAP adherence resonates with patient expectations for personalized healthcare. Effect size is consistent with prior published PAP adherence intervention studies; alternative intervention delivery approaches for home treatment period are recommended. Further testing requires use of pilot study results for a high fidelity clinical trial to test overall efficacy of the intervention. [ABSTRACT FROM AUTHOR]
- Published
- 2016
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