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

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ClinicalTrials.gov Identifier: NCT04366284
Recruitment Status : Not yet recruiting
First Posted : April 28, 2020
Last Update Posted : April 28, 2020
Sponsor:
Collaborators:
United States Department of Defense
Naval Health Research Center
US Air Force Medical Readiness Agency
KNOWESIS, Inc.
Information provided by (Responsible Party):
Anne Germain, Noctem, LLC

Brief 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.

Condition or disease Intervention/treatment Phase
Implementation; Digital Health Chronic Insomnia Other: No Facilitation Support Other: External Facilitation Support Other: External and Internal Facilitation Support Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Optimizing the Scalability of Evidence-Based Behavioral Sleep Medicine Practices With a Digital Health Platform
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

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.




Primary Outcome Measures :
  1. 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.

  2. 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. 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).

  4. Change in Insomnia Severity Index [ Time Frame: From Baseline to Post-Acute Intervention at Week 6 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04366284


Contacts
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Contact: Anne Germain, PhD 412-897-3183 anne@noctemhealth.com

Locations
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United States, California
Naval Health Research Center
San Diego, California, United States, 92152
Contact: Rachel Markwalk, PhD    970-214-1892    rachel.r.markwald.civ@mail.mil   
United States, North Carolina
Pope Army Airfield
Pope Field, North Carolina, United States, 28307
Contact: Chad E Morrow, PsyD         
United States, Texas
Lackland Air Force Base
San Antonio, Texas, United States, 78236
Contact: Joseph Hout, PhD    210-957-3222 ext 202      
Contact       jhout@knowesis-inc.com   
United States, Washington
Madigan Army Medical Center
Tacoma, Washington, United States, 98431
Contact: Brian O'Reilly, DO    253-968-2731    brian.oreilly3.civ@mail.mil   
Sponsors and Collaborators
Noctem, LLC
United States Department of Defense
Naval Health Research Center
US Air Force Medical Readiness Agency
KNOWESIS, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Anne Germain, Principal Investigator, Noctem, LLC
ClinicalTrials.gov Identifier: NCT04366284    
Other Study ID Numbers: 2019-406
MT190002.01 ( Other Grant/Funding Number: MTEC/MOMRP )
First Posted: April 28, 2020    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anne Germain, Noctem, LLC:
Cognitive-Behavioral Therapy for Insomnia
Implementation-Effectiveness
Dissemination and Implementation Research
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders