Insomnia Clinical Trial
— SMART DOCSOfficial title:
Sustainable Methods, Algorithms, and Research Tools for Delivering Optimal Care Study (SMART DOCS)
Verified date | November 2018 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Sustainable Methods, Algorithms, and Research Tools for Delivering Optimal Care Study (SMART DOCS) was designed to develop and evaluate a new approach (patient-centered outcomes and coordinated-care management [PCCM]) for the diagnosis and treatment of sleep disorders. Specialized and pertinent information and resources regarding sleep disorder management were developed and made available through an online portal, allowing patients to make informed health care decisions, and providers to assist patients in achieving what they feel are the most important goals regarding their care. Half of participants were randomized into the conventional diagnosis and treatment (CONV) arm and the other half into the patient-centered outcomes and coordinated-care management (PCCM) arm. Validated objective and subjective assessment measures were administered at intervals throughout a 13 month participation period in both the CONV and PCCM arms to determine whether the new PCCM approach for sleep medicine results in increased patient satisfaction, quality of care, and improved health outcomes. Qualifying participants were 18 years of age or older and presenting with a new sleep disorder. Patients received no monetary compensation.
Status | Completed |
Enrollment | 1836 |
Est. completion date | May 2016 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 18 years of age and older - New clinical outpatient presenting signs and/or symptoms of a sleep disorder Exclusion Criteria: |
Country | Name | City | State |
---|---|---|---|
United States | Stanford Sleep Clinic, Stanford University Center for Sleep Science and Medicine | Redwood City | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University | Patient-Centered Outcomes Research Institute |
United States,
Kushida CA, Nichols DA, Holmes TH, Miller R, Griffin K, Cardell CY, Hyde PR, Cohen E, Manber R, Walsh JK. SMART DOCS: a new patient-centered outcomes and coordinated-care management approach for the future practice of sleep medicine. Sleep. 2015 Feb 1;38(2):315-26. doi: 10.5665/sleep.4422. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in CGCAHPS Global Rating After 12 Months | Global rating of the provider from the Consumer Assessment of Healthcare Providers and Systems Clinician and Group Survey (CGCAHPS) compared between the two arms at end of study (12 months). The global rating instructions specify: "Using any number from 0 to 10, where 0 is the worst provider possible, and 10 is the best provider possible, what number would you use to rate this provider?" | 12 months | |
Primary | Change in SF-36 Version 2 Health Survey Vitality Score After 12 Months | The vitality scale score of the Short Form-36 (SF-36) Version 2 Health Survey was compared at the end-of study (12 months) and was derived from the following four questions: "How much of the time during the past 4 weeks… Did you feel full of life?" "Did you have a lot of energy?" "Did you feel worn out?" "Did you feel tired?" The possible responses and point values were: all of the time (1), most of the time (2), some of the time (3), a little of the time (4), and none of the time (5). The scale is transformed to a 0-100 scale, with the lower the score indicating more disability. | 12 months | |
Secondary | Change in CGCAHPS Provider Communication After 12 Months | Communication of provider as measured by the Consumer Assessment of Healthcare Providers and Systems Clinician and Group Survey (CGCAHPS). This comprised "How Well Providers (or Doctors) Communicate with Patients" The ratings for the following four questions were averaged for each participant: "In the last 12 months, how often did this provider explain things in a way that was easy to understand?" "In the last 12 months, how often did this provider listen carefully to you?" "In the last 12 months, how often did this provider show respect for what you had to say?" "In the last 12 months, how often did this provider spend enough time with you?" The responses and point values were: never (1), sometimes (2), usually (3), and always (4). | 12 months | |
Secondary | Change in CGCAHPS Health Information Technology Measure #1 After 12 Months | Helpfulness of Provider's Use of Computers During a Visit (Effectiveness of technology as measured by the Health Information Technology item set of the Consumer Assessment of Healthcare Providers and Systems Clinician and Group Survey [CGCAHPS]). This included composite measures of helpfulness of provider's use of computers during a visit. The ratings for the following two questions were averaged for each participant: "During your visits in the last 12 months, was this provider's use of a computer or handheld device helpful to you?" The point values for the responses were: yes, definitely (1), yes, somewhat (2), and no (3). "During your visits in the last 12 months, did this provider's use of a computer or handheld device make it harder or easier for you to talk with him or her?" The point values for the responses were: easier (1), not harder or easier (2), harder (3). | 12 months | |
Secondary | Change in CGCAHPS Health Information Technology Measure #3 After 12 Months | Helpfulness of Provider's Website in Giving Patient Information About Patient's Care and Tests (Effectiveness of technology as measured by the Health Information Technology item set of the Consumer Assessment of Healthcare Providers and Systems Clinician and Group Survey [CGCAHPS]). This included composite measures of helpfulness of provider's website in giving information about care and tests. The ratings for the following four questions were averaged for each participant: "In the last 12 months, how often was it easy to find these lab or other test results on the website?" "In the last 12 months, how often were these lab or other test results put on the website as soon as you needed them?" "In the last 12 months, how often were these lab or other test results presented in a way that was easy to understand?" "In the last 12 months, how often were the visit notes easy to understand?" The responses and point values were: never (1), sometimes (2), usually (3), and always (4). | 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04512768 -
Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy
|
N/A | |
Recruiting |
NCT05963542 -
Efficacy of Online Acceptance and Commitment Therapy and Sound Therapy for Patients With Tinnitus and Insomnia
|
N/A | |
Completed |
NCT06339853 -
Study of Efficacy of Digital Cognitive Behavioral Therapy With Wearable Device for Insomnia
|
N/A | |
Recruiting |
NCT04069247 -
Effectiveness of eCBT-I on Improving Mental Health in Chinese Youths With Insomnia
|
N/A | |
Completed |
NCT04493593 -
Internet-delivered CBT-I (Space for Sleep): Pilot and Feasibility
|
N/A | |
Recruiting |
NCT06278077 -
Neurexan - a Clinical Trial in Short-Term Insomnia Patients
|
Phase 2 | |
Recruiting |
NCT05956886 -
Sleep Chatbot Intervention for Emerging Black/African American Adults
|
N/A | |
Completed |
NCT04661306 -
The Better Sleep for Supporters With Insomnia Study
|
N/A | |
Recruiting |
NCT06207279 -
Preliminary Study on the Development and Reliability and Validity of Attention Rating Scale
|
||
Recruiting |
NCT06006299 -
Investigating the Use of taVNS to Treat Insomnia in Individuals With Breast Cancer (taVNS-insomnia-BC)
|
N/A | |
Completed |
NCT03683381 -
App-based Intervention for Treating Insomnia Among Patients With Epilepsy
|
N/A | |
Completed |
NCT04564807 -
Testing an Online Insomnia Intervention
|
N/A | |
Completed |
NCT03673397 -
The Acute Effect of Aerobic Exercise on Sleep in Patients With Depression
|
N/A | |
Completed |
NCT04035200 -
Safety, Tolerability and Efficacy Study of V117957 in Subjects With Insomnia Associated With Alcohol Cessation
|
Phase 2 | |
Active, not recruiting |
NCT05027438 -
Reducing Use of Sleep Medications Assisted by a Digital Insomnia Intervention
|
N/A | |
Recruiting |
NCT06053840 -
An Open-label Trial to Evaluate the Safety and Efficacy of Chloral Hydrate in Patients With Severe Insomnia
|
Phase 4 | |
Not yet recruiting |
NCT06348082 -
Project Women's Insomnia Sleep Health Equity Study (WISHES)
|
N/A | |
Not yet recruiting |
NCT06363799 -
Osteopathic Protocol for Insomnia in College Students
|
N/A | |
Not yet recruiting |
NCT06025968 -
Digital Cognitive-behavioral Therapy for Insomnia for Patients With Multiple Sclerosis
|
N/A | |
Not yet recruiting |
NCT05991492 -
Improving Sleep With a Digital Cognitive Behavioral Therapy for Insomnia Application
|
N/A |