Tailored Intervention to Promote Positive Airway Pressure Adherence

Sleep Apnea, Obstructive Clinical Trial

— SCIP-PA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01454830
• Other study ID #: 37007
• Secondary ID: 4R00NR011173
• Status: Active, not recruiting
• Phase: Phase 1
• First received: October 12, 2011
• Last updated: December 29, 2013
• Start date: November 2011
• Est. completion date: February 2014

Study information

• Verified date: December 2013
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 72
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Patient Compliance
• Sleep Apnea, Obstructive

Intervention

Behavioral:
• 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

Other:
• 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

Locations

Country	Name	City	State
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	National Institute of Nursing Research (NINR), Sigma Theta Tau International

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nightly CPAP use	Mean CPAP use, hrs/night	1 week	No
Primary	Nightly CPAP use	Mean CPAP use, hrs/night	1 month	No
Primary	Nightly CPAP use	Mean CPAP use, hrs/night	3 months	No
Secondary	Proportion of sleep time on CPAP	% of Total Sleep Time (TST) using CPAP	1 week	No
Secondary	Proportion of patients enrolled after positive screening	Feasibility assessment	24 months	No
Secondary	Proportion of participants complete protocol	Feasibility assessment	24 months	No
Secondary	Proportion of participants who withdrawal	Feasibility assessment	24 months	No
Secondary	Study personnel training costs	Feasibility assessment aimed at projecting budget requirements for subsequent larger trial	24 months	No
Secondary	Acceptability of study intervention and comparative group	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 debriefing (3 months)	3 months	No
Secondary	Proportion of sleep time using CPAP	% of total sleep time (TST) using CPAP	1 month	No
Secondary	Proportion of sleep time using CPAP	% of total sleep time (TST) using CPAP	3 months	No