AdherenceNCT02195531

CPAP (Continuous Positive Airway Pressure) Study Educational Materials and Usage Feedback to Promote CPAP Adherence

A study testing Education and feedback in people with Adherence, run by Philips Respironics at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 21 to 80 years
Conditions the study is for: Adherence
What is being tested?: Education and feedback
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 169 participants
Where: 6 sitesUnited States
Study dates: Jan 2014to May 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 12Show fewer

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

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

NeuroTrials, Inc.
Atlanta, Georgia, 30342
SleepMed of South Carolina
Columbia, South Carolina, 29201
Pulmonary Associates
Glendale, Arizona, 85306
Arkansas Center for Sleep Medicine
Little Rock, Arkansas, 72211
SleepMed of Central Georgia
Macon, Georgia, 31201
SleepMed of Philadelphia
Philadelphia, Pennsylvania, 19118

Other trials in United States

About this study

Official title: BIG4 - CPAP Educational Materials and Usage Feedback to Promote CPAP Adherence

Read the detailed description

Three group, randomized, controlled clinical trial assessing the extent to which tailoring a CPAP intervention entailing education and feedback to the psychological profile of new CPAP users can enhance the impact of the intervention in terms of adherence-related behavior.

Conditions: Adherence
Being tested: Education and feedback
Keywords: Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Education and feedbackBehavioural
Also called Education, Motivational Enhancement technique
The education leaflets are information concerning Obstructive Sleep Apna (OSA) and CPAP treatment. The feedback reports are CPAP usage patterns.

Study groups in NCT02195531
Study group	Role	What they receive
Treatment	Active comparator	Participants will receive education and feedback tailored to the psychological profile of the receiving participant. Receives: Behavioral: Education and feedback
Control Group	Active comparator	Participants will receive education inconsistent with their profile. Receives: Behavioral: Education and feedback
Standard of care	No intervention	Participants will not receive education or feedback.

What is being measured

The primary outcome is the main question the study is designed to answer.

Nightly Adherence
Average usage hours per night
Measured: 3 months
Adherence
Average usage days per week.
Measured: 3 months

Secondary outcomes (5)

Participant's Feedback on Educational Pamphlets - Expectations Scale
Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles.
Participants answered 3 questions about the expected effectiveness of CPAP. These questions were on a scale of 0 to 5, 0 being not effective at all and 5 being extremely effective.
The average response for each questions was analyzed.
Measured: 3 months
Participant's Feedback on Educational Pamphlets - Importance Scale
Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles.
Participants answered one questions about the importance of CPAP. This was was on a scale of 0 to 5, 0 being not important at all and 5 extremely important.
Measured: 3 months
Participant's Feedback on Educational Pamphlets - Self-Efficacy Scale
Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles.
Participants answered 5 questions regarding self-efficacy of use of CPAP. This was on a scale of 0 to 5, 0 being disagree completely and 5 being completely agree.
The average of each question was analyzed.
Measured: 3 months
Participant's Feedback on Educational Pamphlets - Motiviation
Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles.
Participants were asked about there motivation to use CPAP with two questions. These questions were on a scale of 0 to 10, 0 being not at all, 5 being somewhat, and 10 very much.
The average of the questions were analyzed.
Measured: 3 months
Participant's Feedback on Educational Pamphlets - Leaflet Assessment
Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles.
Participants that received the leaflet were asked 15 questions regarding it. The questions were on a scale of 0 to 5, 0 being strongly disagree and 5 being strongly agree.
The average of the scores were calculated and analyzed monthly.
Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2014May 2015

First posted21 Jul 2014 (estimated)
Study startJan 2014
Primary completionMay 2015
Study completionMay 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AdherenceStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 169 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02195531
Sponsor's protocol ID: PGI-BIG4-1331-MS
Status last verified: Jan 2019
First submitted: 14 Jul 2014
Last updated: 5 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 37213195

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: BIG4 - CPAP Educational Materials and Usage Feedback to Promote CPAP Adherence
ClinicalTrials.gov ID: NCT02195531
Acronym / sponsor ID: PGI-BIG4-1331-MS
Conditions: Adherence
Keywords: Adherence
Study type: Interventional
Recruitment status: Completed
Enrolment: 169 participants (actual)
Lead sponsor: Philips RespironicsIndustry (pharma, biotech, devices)
Study start: Jan 2014
Primary completion: May 2015 (actual)
Study completion: May 2015 (actual)
First posted: 21 Jul 2014 (estimated)
Results: Posted 5 Apr 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
Treatment	Active comparator	Behavioral: Education and feedbackParticipants will receive education and feedback tailored to the psychological profile of the receiving participant.
Control Group	Active comparator	Behavioral: Education and feedbackParticipants will receive education inconsistent with their profile.
Standard of care	No intervention	–Participants will not receive education or feedback.

Who may qualify

Ages: 21 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (12 listed)

Inability to provide informed consent
Presence of a comorbid condition that may potentially complicate CPAP adherence, such as:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Education and feedbackAlso: Education, Motivational Enhancement techniqueThe education leaflets are information concerning Obstructive Sleep Apna (OSA) and CPAP treatment. The feedback reports are CPAP usage patterns.	Behavioural	Control Group, Treatment

Primary outcome

Nightly Adherence
Time frame: 3 months
Average usage hours per night
Adherence
Time frame: 3 months
Average usage days per week.

5 secondary outcomes

Participant's Feedback on Educational Pamphlets - Expectations Scale
Time frame: 3 months
Participant's Feedback on Educational Pamphlets - Importance Scale
Time frame: 3 months
Participant's Feedback on Educational Pamphlets - Self-Efficacy Scale
Time frame: 3 months
Participant's Feedback on Educational Pamphlets - Motiviation
Time frame: 3 months
Participant's Feedback on Educational Pamphlets - Leaflet Assessment
Time frame: 2 months

Results and safety

Results posted to the registry on 5 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard of Care	64	63
Treatment Group	49	48
Control Group	56	55

Primary outcome: Nightly Adherence

Time frame: 3 months. Mean (Standard Deviation). Unit: hours

Measure	Treatment n = 48	Control Group n = 55	Standard of Care n = 63
Week 1	4.83 (3.04)	5.82 (3.08)	4.82 (2.90)
Month 1	4.60 (3.09)	4.96 (3.09)	4.19 (3.05)
Month 2	4.32 (3.10)	4.94 (3.08)	3.60 (3.23)
Month 3	4.16 (3.18)	4.63 (3.27)	3.25 (3.27)

Primary outcome: Adherence

Time frame: 3 months. Mean (Standard Deviation). Unit: days per week

Measure	Treatment n = 48	Control Group n = 55	Standard of Care n = 63
Value	5.5 (2.1)	5.8 (1.7)	4.9 (2.5)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: All non-serious and serious adverse events were collected over the 3 month period. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment	0 of 48 (0%)	0 of 48 (0%)	Not reported
Control Group	0 of 55 (0%)	0 of 55 (0%)	Not reported
Standard of Care	0 of 63 (0%)	0 of 63 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37213195Lacroix 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Richard Bogan, MD principal investigator

SleepMed of South Carolina

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Education and feedback in people with Adherence, run by Philips Respironics at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nightly Adherence (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02195531, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2019.