Optimizing the Scalability of Evidence-Based Behavioral Sleep Medicine Practices With a Digital Health Platform

March 19, 2024 updated by: Anne Germain, Noctem, LLC
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92152
        • Naval Health Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: NOCTEM only (NOCTEM)
No external or internal facilitation
Other: No Facilitation Support
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.
Active Comparator: External Facilitation (NOCTEM+EF)
External facilitation only
Other: External Facilitation Support
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.
Active Comparator: External and Internal Facilitation (NOCTEM+EF/IF)
External and internal facilitation
Other: External and Internal Facilitation Support
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 month follow-up
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.
3 month follow-up
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).
6-month follow-up
Change in Insomnia Severity Index
Time Frame: From Baseline to Post-Acute Intervention at Week 6
From Baseline to Post-Acute Intervention at Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Noctem, LLC

Collaborators

United States Department of Defense
Naval Health Research Center
US Air Force Medical Readiness Agency
KNOWESIS, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Actual)

June 30, 2023

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

April 15, 2020

First Submitted That Met QC Criteria

April 27, 2020

First Posted (Actual)

April 28, 2020

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-406
  • MT190002.01 (Other Grant/Funding Number: MTEC/MOMRP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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