Tailored Intervention to Promote Positive Airway Pressure Adherence (SCIP-PA)
This study is currently recruiting participants.
Verified December 2011 by Milton S. Hershey Medical Center
Sponsor:
Milton S. Hershey Medical Center
Collaborators:
Sigma Theta Tau International
Information provided by (Responsible Party):
Amy M. Sawyer, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01454830
First received: October 12, 2011
Last updated: December 8, 2011
Last verified: December 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Sleep Apnea, Obstructive Patient Compliance |
Behavioral: Tailored Other: Usual care |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Phase I Double-blind Randomized Controlled Trial: Sociocultural and Cognitive Perception Intervention to Promote Positive Airway Pressure Adherence |
Resource links provided by NLM:
Further study details as provided by Milton S. Hershey Medical Center:
Primary Outcome Measures:
- Nightly CPAP use [ Time Frame: 1 week ] [ Designated as safety issue: No ]Mean CPAP use, hrs/night
- Nightly CPAP use [ Time Frame: 1 month ] [ Designated as safety issue: No ]Mean CPAP use, hrs/night
- Nightly CPAP use [ Time Frame: 3 months ] [ Designated as safety issue: No ]Mean CPAP use, hrs/night
Secondary Outcome Measures:
- Proportion of sleep time on CPAP [ Time Frame: 1 week ] [ Designated as safety issue: No ]% of Total Sleep Time (TST) using CPAP
- Proportion of patients enrolled after positive screening [ Time Frame: 24 months ] [ Designated as safety issue: No ]Feasibility assessment
- Proportion of participants complete protocol [ Time Frame: 24 months ] [ Designated as safety issue: No ]Feasibility assessment
- Proportion of participants who withdrawal [ Time Frame: 24 months ] [ Designated as safety issue: No ]Feasibility assessment
- Study personnel training costs [ Time Frame: 24 months ] [ Designated as safety issue: No ]Feasibility assessment aimed at projecting budget requirements for subsequent larger trial
- Acceptability of study intervention and comparative group [ Time Frame: 3 months ] [ Designated as safety issue: No ]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)
- Proportion of sleep time using CPAP [ Time Frame: 1 month ] [ Designated as safety issue: No ]% of total sleep time (TST) using CPAP
- Proportion of sleep time using CPAP [ Time Frame: 3 months ] [ Designated as safety issue: No ]% of total sleep time (TST) using CPAP
| Estimated Enrollment: | 72 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Tailored
Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions
|
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 Name: Individualized
|
|
Active Comparator: Usual care
The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment
|
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
Other Name: standard of care
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01454830
Contacts
| Contact: Amy M Sawyer, PhD | 8148631020 | ams24@psu.edu |
Locations
| United States, Pennsylvania | |
| Penn State Hershey Medical Center | Recruiting |
| Hershey, Pennsylvania, United States, 17033 | |
| Contact: Amy M Sawyer, PhD 717-531-8520 ext 3 ams24@psu.edu | |
| Principal Investigator: Amy M Sawyer, PhD | |
Sponsors and Collaborators
Milton S. Hershey Medical Center
Sigma Theta Tau International
Investigators
| Principal Investigator: | Amy M Sawyer, PhD | The Pennsylvania State University |
More Information
Publications:
| Responsible Party: | Amy M. Sawyer, Assistant Professor, Milton S. Hershey Medical Center |
| ClinicalTrials.gov Identifier: | NCT01454830 History of Changes |
| Other Study ID Numbers: | 37007, 4R00NR011173 |
| Study First Received: | October 12, 2011 |
| Last Updated: | December 8, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Milton S. Hershey Medical Center:
|
Social support Cognition Adaptation, psychological Health behavior Patient education |
Additional relevant MeSH terms:
|
Sleep Apnea Syndromes Sleep Apnea, Obstructive Apnea Respiration Disorders Respiratory Tract Diseases |
Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013