NCT02195531

Brief Summary

The study hypothesis: in groups receiving tailored education and feedback in a style that matches their psychological profile, will show a higher CPAP adherence rates than groups receiving mismatched tailored education / feedback, and groups that receive no tailored education and feedback (standard of care).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
169

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 21, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

April 5, 2019

Completed
Last Updated

April 5, 2019

Status Verified

January 1, 2019

Enrollment Period

1.3 years

First QC Date

July 14, 2014

Results QC Date

June 22, 2018

Last Update Submit

January 8, 2019

Conditions

Adherence

Keywords

Adherence

Outcome Measures

Primary Outcomes (2)

  • Nightly Adherence

    Average usage hours per night

    3 months

  • Adherence

    Average usage days per week.

    3 months

Secondary Outcomes (5)

  • Participant's Feedback on Educational Pamphlets - Expectations Scale

    3 months

  • Participant's Feedback on Educational Pamphlets - Importance Scale

    3 months

  • Participant's Feedback on Educational Pamphlets - Self-Efficacy Scale

    3 months

  • Participant's Feedback on Educational Pamphlets - Motiviation

    3 months

  • Participant's Feedback on Educational Pamphlets - Leaflet Assessment

    2 months

Study Arms (3)

Treatment

ACTIVE COMPARATOR

Participants will receive education and feedback tailored to the psychological profile of the receiving participant.

Behavioral: Education and feedback

Control Group

ACTIVE COMPARATOR

Participants will receive education inconsistent with their profile.

Behavioral: Education and feedback

Standard of care

NO INTERVENTION

Participants will not receive education or feedback.

Interventions

Education and feedbackBEHAVIORAL

The education leaflets are information concerning Obstructive Sleep Apna (OSA) and CPAP treatment. The feedback reports are CPAP usage patterns.

Also known as: Education, Motivational Enhancement technique
Control GroupTreatment

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females, ages 21-80 years
  • Prescribed to start CPAP treatment and diagnosed with mild to severe OSA.
  • Recently (within study period) diagnosed with Mild to Severe OSA defined as an Apnea-Hypopnea Index of equal to or greater than 10 events per hour of sleep.
  • CPAP treatment naïve

You may not qualify if:

  • Inability to provide informed consent
  • Presence of a comorbid condition that may potentially complicate CPAP adherence, such as:
  • Unstable depressive disorder
  • Unstable anxiety disorder
  • Dementia
  • Unable to understand study information
  • Obesity Hypoventilation Syndrome
  • Central Sleep Apnea or Complex Sleep Apnea
  • Facial musculoskeletal disorder
  • Unwillingness or inability to use CPAP therapy
  • Unable to return for follow up appointment
  • Use of supplemental oxygen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Pulmonary Associates

Glendale, Arizona, 85306, United States

Location

Arkansas Center for Sleep Medicine

Little Rock, Arkansas, 72211, United States

Location

NeuroTrials, Inc.

Atlanta, Georgia, 30342, United States

Location

SleepMed of Central Georgia

Macon, Georgia, 31201, United States

Location

SleepMed of Philadelphia

Philadelphia, Pennsylvania, 19118, United States

Location

SleepMed of South Carolina

Columbia, South Carolina, 29201, United States

Location

Related Publications (1)

  • Lacroix J, Tatousek J, Den Teuling N, Visser T, Wells C, Wylie P, Rosenberg R, Bogan R. Effectiveness of an Intervention Providing Digitally Generated Personalized Feedback and Education on Adherence to Continuous Positive Airway Pressure: Randomized Controlled Trial. J Med Internet Res. 2023 May 22;25:e40193. doi: 10.2196/40193.

    PMID: 37213195DERIVED

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Results Point of Contact

Title
Senior Scientist
Organization
Philips Research
Joyca.lacroix@philips.com
+31628041122

Study Officials

  • Richard Bogan, MD

    SleepMed of South Carolina

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2014

First Posted

July 21, 2014

Study Start

January 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

April 5, 2019

Results First Posted

April 5, 2019

Record last verified: 2019-01

Locations

US(6)