Multidisciplinary Team Approach: Working Together to Improve Glycemic Control in Hispanic Adults Diabetes

Type 2 Diabetes Clinical Trial

Official title:

Multidisciplinary Team Approach: Working Together to Improve Glycemic Control in Hispanic Adults With Uncontrolled Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03463629
• Other study ID #: HSC-SN-18-0075
• Status: Completed
• Phase: N/A
• Start date: March 21, 2018
• Est. completion date: August 14, 2018

Study information

• Verified date: September 2018
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study seeks to determine if a specialized multidisciplinary diabetes team (SMDT) approach that incorporates the use of the chronic care model can be an effective method for improving glycemic control in Hispanic adults with uncontrolled type 2 diabetes residing in the Rio Grande Valley. The study will expand the current model of care used and focus on the multidimensional aspects that consist of physical, nutritional, educational and psychological needs of this underserved Hispanic population residing in the Rio Grande Valley.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: August 14, 2018
• Est. primary completion date: August 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• 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.
• Traditional model of care
Receive the traditional model of care, but will not receive diabetes education by pharmacists or counseling services

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Doctors Hospital at Renaissance

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Glucose level as indicated by HbA1c levels	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
Primary	Change in glucose level as indicated by HbA1c levels	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	Change in patient satisfaction with a multidisciplinary team approach management as indicated by a diabetes treatment satisfaction questionnaire (DTSQ)		baseline, 3 months
Secondary	Level of diabetes problem areas as assessed by the Problem Areas in Diabetes Questionnaire (PAID) questionnaire		baseline, 3 months
Secondary	Change in body mass index (BMI)		baseline, 3 months
Secondary	Change in weight		baseline, 3 months
Secondary	Change in blood pressure		baseline, 3 months