- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03463629
Multidisciplinary Team Approach: Working Together to Improve Glycemic Control in Hispanic Adults Diabetes
Multidisciplinary Team Approach: Working Together to Improve Glycemic Control in Hispanic Adults With Uncontrolled Type 2 Diabetes
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- The University of Texas Health Science Center at Houston
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Have physician-diagnosed type 2 diabetes
- Be self-identified as Hispanic or Latino
- An A1c value between 9-14% within the last three months
- English or Spanish speaking
Exclusion Criteria:
- Type 1 diabetes or gestational diabetes
- Cognitive impairment
- Prisoners or individuals under detention
- Unable to speak or understand English or Spanish
- Medical history of the end-stage renal disease or undergoing dialysis.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Specialized multidisciplinary diabetes team (SMDT) approach
The implementation of the pilot study will consist of a specialized multidisciplinary diabetes team care (SMDT) that includes endocrinologists, a nurse practitioner, dieticians, pharmacists and a licensed professional counselors (LPCs) to collaborate and coordinate care. Subjects in the pilot study will follow a multidisciplinary team approach process with the following team members: pharmacist, LPC, and dietician. There will be 3 individualized visits: 1 visit with the counselor (LPC), 1 visit with the Pharmacist, and 1 visit with the Dietician. In addition, a follow up phone call post visit, that can range from 5 to 30 minutes, will be scheduled from each of the team members during the study. Also, throughout the pilot study participant's blood glucose readings will be monitored weekly via a transmittable wireless patient transmission monitor. |
The implementation of the pilot study will consist of a specialized multidisciplinary diabetes team care (SMDT) that includes endocrinologists, a nurse practitioner, dieticians, pharmacists and a licensed professional counselors (LPCs) to collaborate and coordinate care. Subjects in the pilot study will follow a multidisciplinary team approach process with the following team members: pharmacist, LPC, and dietician. There will be 3 individualized visits: 1 visit with the counselor (LPC), 1 visit with the Pharmacist, and 1 visit with the Dietician. In addition, a follow up phone call post visit, that can range from 5 to 30 minutes, will be scheduled from each of the team members during the study. Also, throughout the pilot study participant's blood glucose readings will be monitored weekly via a transmittable wireless patient transmission monitor. |
|
Active Comparator: Traditional model of care
Receive the traditional model of care, but will not receive diabetes education by pharmacists or counseling services.
Data for this arm will be collected through retrospective chart review.
|
Receive the traditional model of care, but will not receive diabetes education by pharmacists or counseling services
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in glucose level as indicated by HbA1c levels
Time Frame: baseline, 3 months
|
In this outcome, only the specialized multidisciplinary diabetes team (SMDT) arm (and not the traditional model of care arm) will be assessed.
|
baseline, 3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in patient satisfaction with a multidisciplinary team approach management as indicated by a diabetes treatment satisfaction questionnaire (DTSQ)
Time Frame: baseline, 3 months
|
baseline, 3 months
|
|
Level of diabetes problem areas as assessed by the Problem Areas in Diabetes Questionnaire (PAID) questionnaire
Time Frame: baseline, 3 months
|
baseline, 3 months
|
|
Change in body mass index (BMI)
Time Frame: baseline, 3 months
|
baseline, 3 months
|
|
Change in weight
Time Frame: baseline, 3 months
|
baseline, 3 months
|
|
Change in blood pressure
Time Frame: baseline, 3 months
|
baseline, 3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Glucose level as indicated by HbA1c levels
Time Frame: 3 months
|
The objective of this outcome is to compare and evaluate HbA1c results from participants that received care through a multidisciplinary diabetes team with patients that have received only the traditional model of care.
|
3 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Mayra J Cantu, The University of Texas Health Science Center, Houston
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC-SN-18-0075
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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