Implementation; Digital HealthNCT04366284
Optimizing the Scalability of Evidence-Based Behavioral Sleep Medicine Practices With a Digital Health Platform
A study testing No Facilitation Support, External Facilitation Support and External and Internal Facilitation Support in people with Implementation; Digital Health and Chronic Insomnia, run by Noctem, LLC at 1 site in United States.
Trial summary
The purpose of this study is to compare three different ways to deploy a clinician-decision support platform called NOCTEM COAST among behavioral health care providers who encounter patients with insomnia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Implementation; Digital Health, Chronic Insomnia
- What is being tested?
- No Facilitation Support, External Facilitation Support and External and Internal Facilitation Support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 30 Sep 2024
- 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
- For clinicians:
- Completion of the first half of the workshop or similar Behavioral Sleep Medicine workshop in the past 6 months
- Completion of the second half of the workshop, including a training session to learn about the use of the NOCTEM platform
- See patients who present with insomnia
- Use cognitive-behavioral techniques as part of their practice
- For patients:
Show all 11Show fewer
- Are service members, veterans, or adult dependents who receive behavioral health care at one of the participating sites
- Present with complaints of insomnia
- Own a smart phone or smart device
- Deemed suitable by their clinician to receive the sleep intervention via the NOCTEM platform
- Confirm their willingness to use the NOCTEM app for sleep care with their provider
Who cannot join
- For clinicians:
- Do not provide direct behavioral health care to service members
- Do not complete the two-part workshop and the 2-week proficiency training
- For patients (recommended):
- Suspected, diagnosed, or inadequately untreated sleep apnea (less than 4 hours of continuous positive airway pressure [CPAP] use per night)
- Psychotic symptoms
- A history of bipolar disorders
- Women who are pregnant or breastfeeding and parents of children younger than 3 months of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Naval Health Research Center
San Diego, California, 92152
About this study
The purpose of this study is to compare three different ways to deploy a clinician-decision support platform called NOCTEM COAST among behavioral health care providers who encounter patients with insomnia.
Read the detailed description
Insomnia and other sleep disorders are highly prevalent among military service members and compromise readiness, health, and performance; increase the risk of injury; and are associated with astronomical healthcare costs. The first-line treatment recommended for insomnia is cognitive-behavioral treatment for insomnia (CBTI). However, the large number of service members who are in need of this treatment outnumber the clinicians who are experts in behavioral sleep medicine and who currently provide this intervention in a cost-efficient manner and in a way that is acceptable and accessible to patients and clinicians. To address this challenge and scale the delivery and access to evidence-based behavioral sleep interventions, NOCTEM™ has developed a digital health platform called COAST (Clinician Operated Assistive Sleep Technology). However, the most effective way to implement the use of digital sleep health technology, and its comparative impact on patient outcomes, remain to be determined. Therefore, this trial will compare three different ways to deploy the NOCTEM™ platform among behavioral health care providers who encounter patients with insomnia. Specifically, the study will evaluate and compare without external or internal support (NOCTEM), with external support (i.e., facilitation) offered by the NOCTEM team (NOCTEM+EF), and with external support and internal support from local champions (NOCTEM+EF/IF). The trial will also compare the overall magnitude of improvements in insomnia among patients who use the NOCTEM app with their provider.
- Conditions
- Implementation; Digital Health, Chronic Insomnia
- Being tested
- No Facilitation Support, External Facilitation Support, External and Internal Facilitation Support
- Keywords
- Cognitive-Behavioral Therapy for Insomnia, Implementation-Effectiveness, Dissemination and Implementation Research
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Facilitation SupportOther
Clinicians will have full use of the NOCTEM platform. They will not have scheduled and/or structured contacts with the facilitation teams, however can reach out to the NOCTEM team or their local point of contact and coordinator with questions or technical issues that may arise.
External Facilitation SupportOther
Clinicians will have full use of the NOCTEM platform and the NOCTEM team will provide external facilitation via bi-weekly consult or supervision teleconference, or via telephone. The NOCTEM team will also be available by email and text messaging on an as needed basis.
External and Internal Facilitation SupportOther
Clinicians will have full use of the NOCTEM platform and external facilitation support. In addition to external facilitation by the NOCTEM team a local point of contact and coordinator will serve as a more proximal facilitator.
| Study group | Role | What they receive |
|---|---|---|
| NOCTEM only (NOCTEM) | Active comparator | No external or internal facilitation Receives: Other: No Facilitation Support |
| External Facilitation (NOCTEM+EF) | Active comparator | External facilitation only Receives: Other: External Facilitation Support |
| External and Internal Facilitation (NOCTEM+EF/IF) | Active comparator | External and internal facilitation Receives: Other: External and Internal Facilitation Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reach among clinicians randomized to NOCTEM only, NOCTEM+EF, or NOCTEM+EF/IF
The ratio of clinicians who consent to participate and complete the NOCTEM training over the number of clinicians who received information about the training.
Measured: 3 month follow-up
Adoption among clinicians randomized to NOCTEM only, NOCTEM+EF, or NOCTEM+EF/IF
The ratio of newly trained clinicians who use the NOCTEM system over the total number of clinicians who completed the NOCTEM training.
Measured: 3 month follow-up
Maintenance (sustainability) among clinicians randomized to NOCTEM only, NOCTEM+EF, or NOCTEM+EF/IF
Comparison of frequency of use of the NOCTEM platform by the trained clinicians, across the three groups (NOCTEM vs. NOCTEM+EF vs. NOCTEM+EF/IF).
Measured: 6-month follow-up
Change in Insomnia Severity Index
Measured: From Baseline to Post-Acute Intervention at Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start1 Sep 2020
- Primary completion30 Jun 2023
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Implementation; Digital HealthStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noctem, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense, Naval Health Research Center, US Air Force Medical Readiness Agency, KNOWESIS, Inc.
- Responsible party
- Principal investigator, Anne Germain, Noctem, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04366284
- Sponsor's protocol ID
- 2019-406
- Other IDs
- MT190002.01
- Status last verified
- Jun 2023
- First submitted
- 15 Apr 2020
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Germain A, Markwald RR, King E, Bramoweth AD, Wolfson M, Seda G, Han T, Miggantz E, O'Reilly B, Hungerford L, Sitzer T, Mysliwiec V, Hout JJ, Wallace ML. Enhancing behavioral sleep care with digital technology: study protocol for a hybrid type 3 implementation-effectiveness randomized trial. Trials. 2021 Jan 11;22(1):46. doi: 10.1186/s13063-020-04974-z.
PubMed 33430955
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing the Scalability of Evidence-Based Behavioral Sleep Medicine Practices With a Digital Health Platform
- ClinicalTrials.gov ID
- NCT04366284
- Acronym / sponsor ID
- 2019-406
- Conditions
- Implementation; Digital Health, Chronic Insomnia
- Keywords
- Cognitive-Behavioral Therapy for Insomnia, Implementation-Effectiveness, Dissemination and Implementation Research
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Noctem, LLCIndustry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense, Naval Health Research Center, US Air Force Medical Readiness Agency, KNOWESIS, Inc.
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 28 Apr 2020 (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.
The purpose of this study is to compare three different ways to deploy a clinician-decision support platform called NOCTEM COAST among behavioral health care providers who encounter patients with insomnia.
Detailed description
Insomnia and other sleep disorders are highly prevalent among military service members and compromise readiness, health, and performance; increase the risk of injury; and are associated with astronomical healthcare costs. The first-line treatment recommended for insomnia is cognitive-behavioral treatment for insomnia (CBTI). However, the large number of service members who are in need of this treatment outnumber the clinicians who are experts in behavioral sleep medicine and who currently provide this intervention in a cost-efficient manner and in a way that is acceptable and accessible to patients and clinicians. To address this challenge and scale the delivery and access to evidence-based behavioral sleep interventions, NOCTEM™ has developed a digital health platform called COAST (Clinician Operated Assistive Sleep Technology). However, the most effective way to implement the use of digital sleep health technology, and its comparative impact on patient outcomes, remain to be determined. Therefore, this trial will compare three different ways to deploy the NOCTEM™ platform among behavioral health care providers who encounter patients with insomnia. Specifically, the study will evaluate and compare without external or internal support (NOCTEM), with external support (i.e., facilitation) offered by the NOCTEM team (NOCTEM+EF), and with external support and internal support from local champions (NOCTEM+EF/IF). The trial will also compare the overall magnitude of improvements in insomnia among patients who use the NOCTEM app with their provider.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NOCTEM only (NOCTEM) | Active comparator | Other: No Facilitation SupportNo external or internal facilitation |
| External Facilitation (NOCTEM+EF) | Active comparator | Other: External Facilitation SupportExternal facilitation only |
| External and Internal Facilitation (NOCTEM+EF/IF) | Active comparator | Other: External and Internal Facilitation SupportExternal and internal facilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Completion of the first half of the workshop or similar Behavioral Sleep Medicine workshop in the past 6 months
- Completion of the second half of the workshop, including a training session to learn about the use of the NOCTEM platform
- See patients who present with insomnia
- Use cognitive-behavioral techniques as part of their practice
- Are service members, veterans, or adult dependents who receive behavioral health care at one of the participating sites
Key exclusion criteria (8 listed)
- Do not provide direct behavioral health care to service members
- Do not complete the two-part workshop and the 2-week proficiency training
- Suspected, diagnosed, or inadequately untreated sleep apnea (less than 4 hours of continuous positive airway pressure [CPAP] use per night)
- Psychotic symptoms
- A history of bipolar disorders
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 |
|---|---|---|
| No Facilitation SupportClinicians will have full use of the NOCTEM platform. They will not have scheduled and/or structured contacts with the facilitation teams, however can reach out to the NOCTEM team or their local point of contact and coordinator with questions or technical issues that may arise. | Other | NOCTEM only (NOCTEM) |
| External Facilitation SupportClinicians will have full use of the NOCTEM platform and the NOCTEM team will provide external facilitation via bi-weekly consult or supervision teleconference, or via telephone. The NOCTEM team will also be available by email and text messaging on an as needed basis. | Other | External Facilitation (NOCTEM+EF) |
| External and Internal Facilitation SupportClinicians will have full use of the NOCTEM platform and external facilitation support. In addition to external facilitation by the NOCTEM team a local point of contact and coordinator will serve as a more proximal facilitator. | Other | External and Internal Facilitation (NOCTEM+EF/IF) |
Primary outcome
Reach among clinicians randomized to NOCTEM only, NOCTEM+EF, or NOCTEM+EF/IF
Time frame: 3 month follow-up
The ratio of clinicians who consent to participate and complete the NOCTEM training over the number of clinicians who received information about the training.
Adoption among clinicians randomized to NOCTEM only, NOCTEM+EF, or NOCTEM+EF/IF
Time frame: 3 month follow-up
The ratio of newly trained clinicians who use the NOCTEM system over the total number of clinicians who completed the NOCTEM training.
Maintenance (sustainability) among clinicians randomized to NOCTEM only, NOCTEM+EF, or NOCTEM+EF/IF
Time frame: 6-month follow-up
Comparison of frequency of use of the NOCTEM platform by the trained clinicians, across the three groups (NOCTEM vs. NOCTEM+EF vs. NOCTEM+EF/IF).
Change in Insomnia Severity Index
Time frame: From Baseline to Post-Acute Intervention at Week 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Derived from this study: PubMed 33430955Germain A, Markwald RR, King E, Bramoweth AD, Wolfson M, Seda G, Han T, Miggantz E, O'Reilly B, Hungerford L, Sitzer T, Mysliwiec V, Hout JJ, Wallace ML. Enhancing behavioral sleep care with digital technology: study protocol for a hybrid type 3 implementation-effectiveness randomized trial. Trials. 2021 Jan 11;22(1):46. doi: 10.1186/s13063-020-04974-z.
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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 No Facilitation Support, External Facilitation Support and External and Internal Facilitation Support in people with Implementation; Digital Health and Chronic Insomnia, run by Noctem, LLC 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 11 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 20 Mar 2024. 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?
Results are not available in the source record.
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?
Reach among clinicians randomized to NOCTEM only, NOCTEM+EF, or NOCTEM+EF/IF (time frame: 3 month follow-up). The study lists 4 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 NCT04366284, 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 20 Mar 2024.