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

Primary Purpose

Implementation; Digital Health, Chronic Insomnia

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
No Facilitation Support
External Facilitation Support
External and Internal Facilitation Support
Sponsored by
Noctem, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Implementation; Digital Health focused on measuring Cognitive-Behavioral Therapy for Insomnia, Implementation-Effectiveness, Dissemination and Implementation Research

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Naval Health Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

NOCTEM only (NOCTEM)

External Facilitation (NOCTEM+EF)

External and Internal Facilitation (NOCTEM+EF/IF)

Arm Description

No external or internal facilitation

External facilitation only

External and internal facilitation

Outcomes

Primary Outcome Measures

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.
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.
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).
Change in Insomnia Severity Index

Secondary Outcome Measures

Full Information

First Posted
April 15, 2020
Last Updated
March 2, 2021
Sponsor
Noctem, LLC
Collaborators
United States Department of Defense, Naval Health Research Center, US Air Force Medical Readiness Agency, KNOWESIS, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04366284
Brief Title
Optimizing the Scalability of Evidence-Based Behavioral Sleep Medicine Practices With a Digital Health Platform
Official Title
Optimizing the Scalability of Evidence-Based Behavioral Sleep Medicine Practices With a Digital Health Platform
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
November 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Noctem, LLC
Collaborators
United States Department of Defense, Naval Health Research Center, US Air Force Medical Readiness Agency, KNOWESIS, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Implementation; Digital Health, Chronic Insomnia
Keywords
Cognitive-Behavioral Therapy for Insomnia, Implementation-Effectiveness, Dissemination and Implementation Research

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NOCTEM only (NOCTEM)
Arm Type
Active Comparator
Arm Description
No external or internal facilitation
Arm Title
External Facilitation (NOCTEM+EF)
Arm Type
Active Comparator
Arm Description
External facilitation only
Arm Title
External and Internal Facilitation (NOCTEM+EF/IF)
Arm Type
Active Comparator
Arm Description
External and internal facilitation
Intervention Type
Other
Intervention Name(s)
No Facilitation Support
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
External Facilitation Support
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
External and Internal Facilitation Support
Intervention Description
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 Measure Information:
Title
Reach among clinicians randomized to NOCTEM only, NOCTEM+EF, or NOCTEM+EF/IF
Description
The ratio of clinicians who consent to participate and complete the NOCTEM training over the number of clinicians who received information about the training.
Time Frame
3 month follow-up
Title
Adoption among clinicians randomized to NOCTEM only, NOCTEM+EF, or NOCTEM+EF/IF
Description
The ratio of newly trained clinicians who use the NOCTEM system over the total number of clinicians who completed the NOCTEM training.
Time Frame
3 month follow-up
Title
Maintenance (sustainability) among clinicians randomized to NOCTEM only, NOCTEM+EF, or NOCTEM+EF/IF
Description
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).
Time Frame
6-month follow-up
Title
Change in Insomnia Severity Index
Time Frame
From Baseline to Post-Acute Intervention at Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Germain, PhD
Phone
412-897-3183
Email
anne@noctemhealth.com
Facility Information:
Facility Name
Naval Health Research Center
City
San Diego
State/Province
California
ZIP/Postal Code
92152
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Markwalk, PhD
Phone
970-214-1892
Email
rachel.r.markwald.civ@mail.mil

12. IPD Sharing Statement

Citations:
PubMed Identifier
33430955
Citation
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.
Results Reference
derived

Learn more about this trial

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

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