Obstructive Sleep ApneaNCT01916655
Improving the Frequency and Quality of Sleep Apnea Care Management
A study testing Self-Management Care and Self-Management Mobile Care in people with Obstructive Sleep Apnea, run by VA Office of Research and Development at 1 site in United States.
Trial summary
OSA is a major chronic condition affecting the quality of life of millions of Americans. Per the Institute of Medicine new treatment adherence strategies are needed to help improve the quality of care, reduce social and economic costs, and help those with chronic conditions (such as OSA) live healthier and more… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Self-Management Care and Self-Management Mobile Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2015to 30 Mar 2018
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The project will have a 4-year timeline. Patients and providers at both the VA Pulmonary Sleep Clinic will participate in this prospective randomized clinical trial. Patients will participate by completing written informed consent, agreeing to be randomized, completing a baseline assessment, participating in the study interventional protocol, and completing follow-up assessments up to one-year post-intervention. The intent is to recruit a study population that is fairly representative of the overall VASDHS population of patients diagnosed with OSA. To this end, inclusion criteria are designed to be as inclusive as possible and are operationalized as follows:
- age > 18 years;
- confirmed diagnosis of OSA;
- being newly prescribed CPAP therapy; and
- having chronic symptoms as noted on screening symptom checklist. OSA diagnosis by the Sleep Clinic has been and is currently consistent with published consensus statements49 that CPAP treatment is indicated when the apnea-hypopnea index (AHI, number of apneas + hypopneas per hour of sleep) is either (1) greater than or equal to 15, or (2) between 5 and 15 AND accompanied by documented sleep apnea symptoms, including excessive daytime sleepiness, impaired cognition, mood disorders, insomnia, and documented cardiovascular diseases. Because mild OSA symptoms are at best modestly correlated with AHI, the research study will focus on patients with moderate to severe sleep apnea, and therefore inclusion criteria will require AHI > 15.
Who cannot join
- Exclusion criteria include cognitive impairment sufficient to cause inability to complete the protocol (MMSE < 24/30);
- residence in a geographical area outside of San Diego County (which could make some necessary face-to-face contact difficult);
- fatal comorbidity (life expectancy less than 6 months as indicated by treating physician);
- significant documented substance/chemical abuse; or
- other participant circumstances that, in the opinion of a consensus of study team, would interfere with the safety of a prospective participant or their need for treatment (i.e., clinical needs of patient outweighs needs of research study). No exclusion criteria or any other study design elements will be used directly or indirectly to restrict study participation by women, members of minority groups, or primary language. Because men have a greater risk for OSA (and are identified and diagnosed at a greater rate) than women, we anticipate a final sample that reflects the OSA base rate differences on sex. Some minority groups are thought to have higher OSA prevalence rates than Caucasians, so assuming they are being screened/diagnosed at the same rates as Caucasians, we expect minority groups to be included in the study at levels that reflect those rates.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161
About this study
OSA is a major chronic condition affecting the quality of life of millions of Americans. Per the Institute of Medicine new treatment adherence strategies are needed to help improve the quality of care, reduce social and economic costs, and help those with chronic conditions (such as OSA) live healthier and more productive lives through better management of their conditions. Using an mHealth tool to help deliver the investigators' Self-Management intervention and improve the frequency and quality of patient-provider communications is a central component of that discovery process.
Read the detailed description
The objective of this proposal is to evaluate a new mobile health (mHealth) system for patients with Obstructive Sleep Apnea syndrome (OSA) that facilitates patient-centered, collaborative management for patients prescribed the first-line treatment, continuous positive airway pressure (CPAP). CPAP adherence rates are disappointingly low. The mHealth system proposed for use in the study is informed by the group's previous interventional efforts, including that of an interactive website intervention for OSA patients prescribed CPAP. Limitations of that intervention included use of an immobile desktop computer for website access and that it was not based on a previously evaluated protocol. The advantages to the proposed mHealth system are the use of a mobile device to allow for increased patient-provider communications and the incorporation of the Sleep Apnea Self-Management Program protocol. The evaluative aspect of this proposal is designed as a randomized, controlled clinical trial-Usual Care (control; UC); Self-Management Care (intervention 1; SM); Self-Management via mHealth (intervention 2; SM-Mobile). The key feature of the SM-Mobile intervention is the use of a mHealth tool that allows for the provision of the Self-Management Program through the utilization of audio/visual conferencing, self-monitoring, and treatment tracking with the patient remotely (i.e., in the non-clinic environment).
The overarching aim of the present project is to examine the effect of this patient-centered, collaborative care intervention on improving the quality of care, and increasing CPAP adherence to a clinically meaningful level. The central questions that encompass the conceptual and empirical contours of the study: Does the SM-Mobile intervention have an effect on the patient's experience of care, CPAP adherence, and OSA outcomes relative to Usual Care and Self-Management Care? To answer these research questions, and in the process address fundamental intervention efficacy and cost issues in telemedicine, the proposed randomized, controlled trial aims specifically to achieve the following goals:
This project has the following specific aims:
Aim 1: To examine the effect of the Self-Management Care delivered by mHealth (SM-Mobile) intervention compared to Usual Care (SM) and Self-Management Care (SM) on level of CPAP adherence. The hypothesis is that participants in SM-Mobile group will exhibit higher levels of CPAP adherence compared to the UC and SM groups over the 2-month intervention period.
Aim 2: To examine the effect of the SM-Mobile intervention, compared to Usual Care and Self-Management Care, on the patient's experience of the quality of patient-centered, collaborative care (as measured by the Patient Assessment of Chronic Illness Care and the CAHPS Clinician \& Group Survey). The hypothesis is that participants in the SM-Mobile group will experience a greater improvement in patient-centered, collaborative care compared to the UC and SM groups over the 2-month follow-up period.
Aim 3: To examine the effect of SM-Mobile, compared to UC and SM, on OSA apnea outcomes (e.g., OSA symptoms and OSA-specific health-related quality of life [HRQOL]). The hypothesis is that participants in the SM-Mobile group will experience greater improvements in self-reported OSA symptoms and HRQOL from baseline compared to the UC and SM over the 2-month follow-up period.
Aim 4: To perform a basic cost analysis of the SM-Mobile intervention compared to Usual Care, applying a micro-cost methodology of measuring the quantity of inputs used in the production of care and the unit cost of each. This will be a test against the null hypothesis of no significant cost differences between groups.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Self-Management Care, Self-Management Mobile Care, Usual Care
- Keywords
- Obstructive Sleep Apnea, Adherence, Chronic Disease, Telemedicine, Continuous Positive Airway Pressure, Mobile Health
- Medical subject headings
- Sleep Apnea, Obstructive, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Management CareBehavioural
Provision of sleep apnea-specific self-management education and support for those who are prescribed CPAP therapy
Self-Management Mobile CareBehavioural
Provision of sleep apnea-specific self-management education and support for those who are prescribed CPAP therapy via mobile phone
Usual CareBehavioural
standard and typical CPAP educational and support protocol; is the base level education and support that is provided in the other two interventions in this study.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Placebo comparator | standard and typical PAP (Positive Airway Pressure) educational and support protocol Receives: Behavioral: Usual Care |
| Self-Management Care | Experimental | Individualized self-management educational and support protocol Receives: Behavioral: Self-Management Care; Behavioral: Usual Care |
| Self-Management Mobile Care | Experimental | Individualized self-management educational and support protocol delivered in part by mobile health tool Receives: Behavioral: Self-Management Mobile Care; Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Airway Pressure Adherence
objective measurement of the amount of time PAP therapy is used at the prescribed pressure
Measured: 2 month time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study start3 Aug 2015
- Primary completion30 Dec 2017
- Study completion30 Mar 2018
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.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Carl J Stepnowsky, PhD, Principal investigator, VA San Diego Healthcare System, San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01916655
- Sponsor's protocol ID
- IIR 12-069
- Status last verified
- Jul 2019
- First submitted
- 19 Jul 2013
- Last updated
- 6 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- 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 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Frequency and Quality of Sleep Apnea Care Management
- ClinicalTrials.gov ID
- NCT01916655
- Acronym / sponsor ID
- IIR 12-069
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive Sleep Apnea, Adherence, Chronic Disease, Telemedicine, Continuous Positive Airway Pressure, Mobile Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 3 Aug 2015 (actual)
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 5 Aug 2013 (estimated)
- Results
- Posted 6 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OSA is a major chronic condition affecting the quality of life of millions of Americans. Per the Institute of Medicine new treatment adherence strategies are needed to help improve the quality of care, reduce social and economic costs, and help those with chronic conditions (such as OSA) live healthier and more productive lives through better management of their conditions. Using an mHealth tool to help deliver the investigators' Self-Management intervention and improve the frequency and quality of patient-provider communications is a central component of that discovery process.
Detailed description
The objective of this proposal is to evaluate a new mobile health (mHealth) system for patients with Obstructive Sleep Apnea syndrome (OSA) that facilitates patient-centered, collaborative management for patients prescribed the first-line treatment, continuous positive airway pressure (CPAP). CPAP adherence rates are disappointingly low. The mHealth system proposed for use in the study is informed by the group's previous interventional efforts, including that of an interactive website intervention for OSA patients prescribed CPAP. Limitations of that intervention included use of an immobile desktop computer for website access and that it was not based on a previously evaluated protocol. The advantages to the proposed mHealth system are the use of a mobile device to allow for increased patient-provider communications and the incorporation of the Sleep Apnea Self-Management Program protocol. The evaluative aspect of this proposal is designed as a randomized, controlled clinical trial-Usual Care (control; UC); Self-Management Care (intervention 1; SM); Self-Management via mHealth (intervention 2; SM-Mobile). The key feature of the SM-Mobile intervention is the use of a mHealth tool that allows for the provision of the Self-Management Program through the utilization of audio/visual conferencing, self-monitoring, and treatment tracking with the patient remotely (i.e., in the non-clinic environment).
The overarching aim of the present project is to examine the effect of this patient-centered, collaborative care intervention on improving the quality of care, and increasing CPAP adherence to a clinically meaningful level. The central questions that encompass the conceptual and empirical contours of the study: Does the SM-Mobile intervention have an effect on the patient's experience of care, CPAP adherence, and OSA outcomes relative to Usual Care and Self-Management Care? To answer these research questions, and in the process address fundamental intervention efficacy and cost issues in telemedicine, the proposed randomized, controlled trial aims specifically to achieve the following goals:
This project has the following specific aims:
Aim 1: To examine the effect of the Self-Management Care delivered by mHealth (SM-Mobile) intervention compared to Usual Care (SM) and Self-Management Care (SM) on level of CPAP adherence. The hypothesis is that participants in SM-Mobile group will exhibit higher levels of CPAP adherence compared to the UC and SM groups over the 2-month intervention period.
Aim 2: To examine the effect of the SM-Mobile intervention, compared to Usual Care and Self-Management Care, on the patient's experience of the quality of patient-centered, collaborative care (as measured by the Patient Assessment of Chronic Illness Care and the CAHPS Clinician \& Group Survey). The hypothesis is that participants in the SM-Mobile group will experience a greater improvement in patient-centered, collaborative care compared to the UC and SM groups over the 2-month follow-up period.
Aim 3: To examine the effect of SM-Mobile, compared to UC and SM, on OSA apnea outcomes (e.g., OSA symptoms and OSA-specific health-related quality of life [HRQOL]). The hypothesis is that participants in the SM-Mobile group will experience greater improvements in self-reported OSA symptoms and HRQOL from baseline compared to the UC and SM over the 2-month follow-up period.
Aim 4: To perform a basic cost analysis of the SM-Mobile intervention compared to Usual Care, applying a micro-cost methodology of measuring the quantity of inputs used in the production of care and the unit cost of each. This will be a test against the null hypothesis of no significant cost differences between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Placebo comparator | Behavioral: Usual Carestandard and typical PAP (Positive Airway Pressure) educational and support protocol |
| Self-Management Care | Experimental | Behavioral: Self-Management Care, Behavioral: Usual CareIndividualized self-management educational and support protocol |
| Self-Management Mobile Care | Experimental | Behavioral: Self-Management Mobile Care, Behavioral: Usual CareIndividualized self-management educational and support protocol delivered in part by mobile health tool |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The project will have a 4-year timeline. Patients and providers at both the VA Pulmonary Sleep Clinic will participate in this prospective randomized clinical trial. Patients will participate by completing written informed consent, agreeing to be randomized, completing a baseline assessment, participating in the study interventional protocol, and completing follow-up assessments up to one-year post-intervention. The intent is to recruit a study population that is fairly representative of the overall VASDHS population of patients diagnosed with OSA. To this end, inclusion criteria are designed to be as inclusive as possible and are operationalized as follows:
- age > 18 years;
- confirmed diagnosis of OSA;
- being newly prescribed CPAP therapy; and
- having chronic symptoms as noted on screening symptom checklist. OSA diagnosis by the Sleep Clinic has been and is currently consistent with published consensus statements49 that CPAP treatment is indicated when the apnea-hypopnea index (AHI, number of apneas + hypopneas per hour of sleep) is either (1) greater than or equal to 15, or (2) between 5 and 15 AND accompanied by documented sleep apnea symptoms, including excessive daytime sleepiness, impaired cognition, mood disorders, insomnia, and documented cardiovascular diseases. Because mild OSA symptoms are at best modestly correlated with AHI, the research study will focus on patients with moderate to severe sleep apnea, and therefore inclusion criteria will require AHI > 15.
Key exclusion criteria (5 listed)
- Exclusion criteria include cognitive impairment sufficient to cause inability to complete the protocol (MMSE < 24/30);
- residence in a geographical area outside of San Diego County (which could make some necessary face-to-face contact difficult);
- fatal comorbidity (life expectancy less than 6 months as indicated by treating physician);
- significant documented substance/chemical abuse; or
- other participant circumstances that, in the opinion of a consensus of study team, would interfere with the safety of a prospective participant or their need for treatment (i.e., clinical needs of patient outweighs needs of research study). No exclusion criteria or any other study design elements will be used directly or indirectly to restrict study participation by women, members of minority groups, or primary language. Because men have a greater risk for OSA (and are identified and diagnosed at a greater rate) than women, we anticipate a final sample that reflects the OSA base rate differences on sex. Some minority groups are thought to have higher OSA prevalence rates than Caucasians, so assuming they are being screened/diagnosed at the same rates as Caucasians, we expect minority groups to be included in the study at levels that reflect those rates.
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 |
|---|---|---|
| Self-Management CareProvision of sleep apnea-specific self-management education and support for those who are prescribed CPAP therapy | Behavioural | Self-Management Care |
| Self-Management Mobile CareProvision of sleep apnea-specific self-management education and support for those who are prescribed CPAP therapy via mobile phone | Behavioural | Self-Management Mobile Care |
| Usual Carestandard and typical CPAP educational and support protocol; is the base level education and support that is provided in the other two interventions in this study. | Behavioural | Self-Management Care, Self-Management Mobile Care, Usual Care |
Primary outcome
Positive Airway Pressure Adherence
Time frame: 2 month time point
objective measurement of the amount of time PAP therapy is used at the prescribed pressure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Carl J Stepnowsky, PhD principal investigator
VA San Diego Healthcare System, San Diego, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Management Care and Self-Management Mobile Care in people with Obstructive Sleep Apnea, run by VA Office of Research and Development 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 5 inclusion and 5 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 6 Sep 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. Some participants in this study may receive a placebo. 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 6 Sep 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?
Positive Airway Pressure Adherence (time frame: 2 month time point). 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 6 Sep 2019.