Clinical trial NCT02160639: Evaluating the Impact of Year Long, Augmented Diabetes Self Management Support
Official title: Evaluating the Impact of Year Long, Augmented Diabetes Self Management Support
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus Type 2
Keywords: diabetes self management education
diabetes self management support
type 2 diabetes
Lead sponsor: American Association of Diabetes Educators
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2014-06-11
Enrollment: 449
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Improving diabetes social support is associated with health improvement benefits. This study is a prospective randomized controlled trial comparing the effects of telephone-based diabetes self-management support (DSMS) compared with usual care, which includes diabetes self-management education (DSME), during a 1-year period. It will determine whether this specific model for providing on-going support to people with diabetes will better enable them to maintain the engagement in self-care behaviors, clinical improvements and diabetes-specific knowledge gained during the course of diabetes self-management education.

Detailed description: Diabetes self management support is telephonic and will be provided by health navigators at a central call center

Eligibility criteria: Inclusion Criteria:

* English or Spanish speaking
* Diagnosis of type 2 diabetes mellitus
* HbA1c \> 8
* Have not completed a diabetes self management education program in the past year

Exclusion Criteria:

* Current engagement in cancer treatment
* Diagnosis of end-stage renal disease
* Pregnant
* Receiving immunosuppressant therapy following transplant
* Diagnosis of serious mental illness
* Undergoing systemic treatment with prednisone

Primary outcomes:
measure: Change from baseline HbA1c at 3, 9, 15, and 27 months
timeFrame: 0, 3, 9, 15, and 27 months
measure: Change from baseline blood pressure at 3, 9, 15, and 27 months
timeFrame: 0, 3, 9, 15, and 27 months
measure: Change from baseline cholesterol at 3, 9, 15, and 27 months
timeFrame: 0, 3, 9, 15, and 27 months
measure: Change from baseline BMI at 3, 9, 15, and 27 months
timeFrame: 0, 3, 9, 15, and 27 months
measure: Change from baseline weight at 3, 9, 15, and 27 months
timeFrame: 0, 3, 9, 15, and 27 months
measure: Change from baseline fasting glucose at 3, 9, 15, and 27 months
timeFrame: 0, 3, 9, 15, and 27 months
Secondary outcomes:
measure: Change from baseline patient credential at 3, 9, 15, and 27 months
timeFrame: 0, 3, 9, 15, and 27 months
measure: Change from baseline depression at 3, 9, 15, and 27 months
timeFrame: 0, 3, 9, 15, and 27 months
measure: Change from baseline food security at 3, 9, 15, and 27 months
timeFrame: 0, 3, 9, 15, and 27 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: El Rio Community Health Center
state: Arizona
city: Cape Girardeau
country: United States
facility: Cross Trails Medical Center
state: Missouri
city: High Point
country: United States
facility: Triad Adult and Pediatric Medicine, Inc.
state: North Carolina
city: Scott Depot
country: United States
facility: FamilyCare Health Center
state: West Virginia
Study officials:
affiliation: American Association of Diabetes Educators
name: Dawn Sherr, MS, RD, CDE
role: PRINCIPAL_INVESTIGATOR
References: