Optimizing the Scalability of Evidence-Based Behavioral Sleep Medicine Practices With a Digital Health Platform
2 other identifiers
interventional
17
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2020
CompletedFirst Posted
Study publicly available on registry
April 28, 2020
CompletedStudy Start
First participant enrolled
September 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2024
CompletedMarch 20, 2024
June 1, 2023
2.8 years
April 15, 2020
March 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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.
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.
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).
6-month follow-up
Change in Insomnia Severity Index
From Baseline to Post-Acute Intervention at Week 6
Study Arms (3)
NOCTEM only (NOCTEM)
ACTIVE COMPARATORNo external or internal facilitation
External Facilitation (NOCTEM+EF)
ACTIVE COMPARATORExternal facilitation only
External and Internal Facilitation (NOCTEM+EF/IF)
ACTIVE COMPARATORExternal and internal facilitation
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Noctem, LLClead
- United States Department of Defensecollaborator
- Naval Health Research Centercollaborator
- US Air Force Medical Readiness Agencycollaborator
- KNOWESIS, Inc.collaborator
Study Sites (1)
Naval Health Research Center
San Diego, California, 92152, United States
Related Publications (1)
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.
PMID: 33430955DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 15, 2020
First Posted
April 28, 2020
Study Start
September 1, 2020
Primary Completion
June 30, 2023
Study Completion
September 30, 2024
Last Updated
March 20, 2024
Record last verified: 2023-06