Sleep ApneaNCT04067128
Health Coaching for Positive Airway Pressure Adherence
A study testing Health coaching in people with Sleep Apnea, run by University of California, San Francisco at 1 site in United States.
Trial summary
This study tested a low-resource, brief telephonic health coaching intervention to improve adherence to positive airway pressure therapy for treatment of sleep apnea. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- Health coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2017to 31 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English- or Spanish-speaking
- At least 18 years of age
- Had previously received a modem-enabled positive airway pressure device for the treatment of sleep apnea
- Received care from the San Francisco General Hospital Sleep Clinic
Who cannot join
- Not English- or Spanish-speaking
- Younger than 18 years
- Does not have phone number at which could be reached
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco General Hospital Sleep Clinic
San Francisco, California, 94110
About this study
Official title: Pilot of Brief Health Coaching Intervention to Improve Adherence to Positive Airway Pressure Therapy: Retroactive Analysis of a Quality Improvement Project
This study tested a low-resource, brief telephonic health coaching intervention to improve adherence to positive airway pressure therapy for treatment of sleep apnea.
Read the detailed description
We conducted post hoc analysis of a quality improvement initiative in which patients were randomly assigned to receive health coaching or usual care. Participants were English- and Spanish-speaking patients from a county-based public health system who had previously received a positive airway pressure device for the treatment of sleep apnea. An unlicensed, trained health coach called patients three times to resolve barriers to adherence. Adherence measures collected by device modem at baseline and 4 weeks were the primary outcome measures.
- Conditions
- Sleep Apnea
- Being tested
- Health coaching
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health coachingBehavioural
Brief telephonic intervention consisting of up to three phone calls
| Study group | Role | What they receive |
|---|---|---|
| Health coaching arm | Experimental | For the health coaching arm, an unlicensed, trained health coach called patients three times to identify and resolve barriers to adherence, including lack of understanding of their condition or the treatment, discomfort in acclimating to treatment, technical difficulties in mask fit or device settings, and challenges in navigating durable medical equipment providers. Receives: Behavioral: Health coaching |
| Usual care arm | No intervention | Patients assigned to usual care had access to all other available resources, including technical support from durable medical equipment providers, respiratory therapist visits with the Sleep Clinic, group visits, or visits with their primary care provider. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion using device at any time in last 30 days
Numerator: Number of people using device at any time in last 30 days; Denominator: Number of people in study arm
Measured: Enrollment to 30 days post enrollment
Secondary outcomes (4)
Mean number of hours used on average over the last 30 days
Total number of hours device used during 30 day period divided by 30 days
Measured: Enrollment to 30 days post enrollment
Mean number of hours used on average over the last 30 days on nights that device was used
Total number of hours device used during 30 day period divided by the number of days on which the device was used
Measured: Enrollment to 30 days post enrollment
Mean proportion of last 30 days in which device used at least 4 hours/night
Mean across group of: (Numerator: Number of days in last 30 days that device was used at least 4 hours; Denominator: 30 days)
Measured: Enrollment to 30 days post enrollment
Proportion meeting Medicare standard for adherence (at least 4 hours/night for at least 70% of last 30 days)
Numerator: Number of people meeting Medicare standard for adherence; Denominator: Number of people in study arm
Measured: Enrollment to 30 days post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start1 Mar 2017
- Primary completion31 May 2017
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Model description
- Patients were randomly assigned to receive health coaching or usual care. For the health coaching arm, an unlicensed, trained health coach called patients three times to identify and resolve barriers to adherence, including lack of understanding of their condition or the treatment, discomfort in acclimating to treatment, technical difficulties in mask fit or device settings, and challenges in navigating durable medical equipment providers. Patients assigned to usual care had access to all other available resources, including technical support from durable medical equipment providers, respiratory therapist visits with the Sleep Clinic, group visits, or visits with their primary care provider.
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachel Willard-Grace, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04067128
- Sponsor's protocol ID
- 17-23281
- Status last verified
- Aug 2019
- First submitted
- 21 Aug 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot of Brief Health Coaching Intervention to Improve Adherence to Positive Airway Pressure Therapy: Retroactive Analysis of a Quality Improvement Project
- ClinicalTrials.gov ID
- NCT04067128
- Acronym / sponsor ID
- 17-23281
- Conditions
- Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 26 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study tested a low-resource, brief telephonic health coaching intervention to improve adherence to positive airway pressure therapy for treatment of sleep apnea.
Detailed description
We conducted post hoc analysis of a quality improvement initiative in which patients were randomly assigned to receive health coaching or usual care. Participants were English- and Spanish-speaking patients from a county-based public health system who had previously received a positive airway pressure device for the treatment of sleep apnea. An unlicensed, trained health coach called patients three times to resolve barriers to adherence. Adherence measures collected by device modem at baseline and 4 weeks were the primary outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients were randomly assigned to receive health coaching or usual care. For the health coaching arm, an unlicensed, trained health coach called patients three times to identify and resolve barriers to adherence, including lack of understanding of their condition or the treatment, discomfort in acclimating to treatment, technical difficulties in mask fit or device settings, and challenges in navigating durable medical equipment providers. Patients assigned to usual care had access to all other available resources, including technical support from durable medical equipment providers, respiratory therapist visits with the Sleep Clinic, group visits, or visits with their primary care provider.
| Arm | Type | Receives |
|---|---|---|
| Health coaching arm | Experimental | Behavioral: Health coachingFor the health coaching arm, an unlicensed, trained health coach called patients three times to identify and resolve barriers to adherence, including lack of understanding of their condition or the treatment, discomfort in acclimating to treatment, technical difficulties in mask fit or device settings, and challenges in navigating durable medical equipment providers. |
| Usual care arm | No intervention | –Patients assigned to usual care had access to all other available resources, including technical support from durable medical equipment providers, respiratory therapist visits with the Sleep Clinic, group visits, or visits with their primary care provider. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- English- or Spanish-speaking
- At least 18 years of age
- Had previously received a modem-enabled positive airway pressure device for the treatment of sleep apnea
- Received care from the San Francisco General Hospital Sleep Clinic
Key exclusion criteria (3 listed)
- Not English- or Spanish-speaking
- Younger than 18 years
- Does not have phone number at which could be reached
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 |
|---|---|---|
| Health coachingBrief telephonic intervention consisting of up to three phone calls | Behavioural | Health coaching arm |
Primary outcome
Proportion using device at any time in last 30 days
Time frame: Enrollment to 30 days post enrollment
Numerator: Number of people using device at any time in last 30 days; Denominator: Number of people in study arm
4 secondary outcomes
Mean number of hours used on average over the last 30 days
Time frame: Enrollment to 30 days post enrollment
Mean number of hours used on average over the last 30 days on nights that device was used
Time frame: Enrollment to 30 days post enrollment
Mean proportion of last 30 days in which device used at least 4 hours/night
Time frame: Enrollment to 30 days post enrollment
Proportion meeting Medicare standard for adherence (at least 4 hours/night for at least 70% of last 30 days)
Time frame: Enrollment to 30 days post enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health coaching in people with Sleep Apnea, run by University of California, San Francisco at 1 site 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 3 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 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion using device at any time in last 30 days (time frame: Enrollment to 30 days post enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2019.