Optimizing the Scalability of Evidence-Based Behavioral Sleep Medicine Practices With a Digital Health Platform
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04366284|
Recruitment Status : Not yet recruiting
First Posted : April 28, 2020
Last Update Posted : April 28, 2020
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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 ]
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
|Contact: Anne Germain, PhDfirstname.lastname@example.org|
|United States, California|
|Naval Health Research Center|
|San Diego, California, United States, 92152|
|Contact: Rachel Markwalk, PhD 970-214-1892 email@example.com|
|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|
|United States, Washington|
|Madigan Army Medical Center|
|Tacoma, Washington, United States, 98431|
|Contact: Brian O'Reilly, DO 253-968-2731 firstname.lastname@example.org|