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

This study has been completed.
Sponsor:
Collaborators:
National Institute of Nursing Research (NINR)
ANF
Information provided by (Responsible Party):
Amy M. Sawyer, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01454830
First received: October 12, 2011
Last updated: September 30, 2016
Last verified: September 2016
Results First Received: August 5, 2016  
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
Conditions: Sleep Apnea, Obstructive
Patient Compliance
Interventions: Behavioral: Tailored
Other: Usual care

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period 12/2011 through 1/2014 Location type: clinical sleep center

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Tailored

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

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

Usual Care

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

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


Participant Flow:   Overall Study
    Tailored   Usual Care
STARTED   61   57 
COMPLETED   30   30 
NOT COMPLETED   31   27 
Withdrawal by Subject                4                4 
Post-allocation Exclude- AHI<10                18                12 
Post-allocation Exclude-refused PAP                0                2 
Post-allocation Exclude-other treatment                6                7 
Withdrawal - no polysomnography                3                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Tailored

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

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

Usual Care

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

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

Total Total of all reporting groups

Baseline Measures
   Tailored   Usual Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 30   30   60 
Age 
[Units: Years]
Mean (Standard Deviation)
 52.5  (11.7)   50.1  (10.5)   51.3  (11.1) 
Gender 
[Units: Participants]
     
Female   11   7   18 
Male   19   23   42 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   2   3   5 
Not Hispanic or Latino   28   27   55 
Unknown or Not Reported   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   1   1   2 
Asian   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   5   2   7 
White   24   27   51 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   30   30   60 
Body Mass Index, Continuous 
[Units: Kg/m2]
Mean (Standard Deviation)
 37.0  (8.1)   39.0  (10.3)   38.0  (9.2) 
Marital Status, Categorical 
[Units: Participants]
     
Married   20   25   45 
Single   2   2   4 
Separated or Divorced   6   3   9 
Widow(er)   2   0   2 
Daytime Sleepiness by Epworth Sleepiness Scale, Continuous [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 18.7  (5.1)   20.4  (5.3)   19.6  (5.2) 
[1] Total score (sum) range is 0-24; higher scores indicate worse daytime subjective sleepiness
Apnea-hypopnea Index (AHI), events/hr, Continuous 
[Units: Events/hour]
Mean (Standard Deviation)
 33.9  (21.3)   38.0  (28.8)   35.9  (25.2) 
Apnea-hypopnea Index (AHI), Categorical 
[Units: Participants]
     
Mild: 5-15 events/hr   3   8   11 
Moderate: >15-30 events/hr   13   7   20 
Severe: >30 events/hr   14   15   29 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Nightly CPAP Use   [ Time Frame: 1 week ]

2.  Primary:   Nightly CPAP Use   [ Time Frame: 1 month ]

3.  Primary:   Nightly CPAP Use   [ Time Frame: 3 months ]

4.  Secondary:   Proportion of Sleep Time on CPAP   [ Time Frame: 1 week ]

5.  Secondary:   Proportion of Participants Who Complete Protocol After Allocation   [ Time Frame: Duration of protocol period ]

6.  Secondary:   Proportion of Participants Who Withdrawal   [ Time Frame: Duration of protocol period ]

7.  Secondary:   Acceptability of Study Intervention and Comparative Group   [ Time Frame: 3 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Sampling bias with convenience sampling leading to relatively few PAP users meeting definition of non-adherence (threshold definition </= 4hrs/night PAP use); Modest intervention fidelity (i.e., delivery) for telephone-delivered exposure period


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Amy M. Sawyer, PhD
Organization: The Pennsylvania State University
phone: 814-863-1020
e-mail: ams24@psu.edu


Publications:

Responsible Party: Amy M. Sawyer, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01454830     History of Changes
Other Study ID Numbers: 37007
4R00NR011173 ( US NIH Grant/Contract Award Number )
Study First Received: October 12, 2011
Results First Received: August 5, 2016
Last Updated: September 30, 2016
Health Authority: United States: Institutional Review Board