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

Sponsor

The University of Texas Health Science Center, Houston (Other)

Overall Status

Completed

CT.gov ID

NCT03463629

Collaborator

DHR Health Institute for Research and Development (Other)

Enrollment

Location

Arms

4.8

Actual Duration (Months)

6.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Other: Specialized multidisciplinary diabetes team (SMDT) approach Other: Traditional model of care	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

33 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 21, 2018

Actual Primary Completion Date :

Aug 14, 2018

Actual Study Completion Date :

Aug 14, 2018

Arms and Interventions

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

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.

Other: Specialized multidisciplinary diabetes team (SMDT) approach

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.

Other: Traditional model of care

Receive the traditional model of care, but will not receive diabetes education by pharmacists or counseling services

Outcome Measures

Primary Outcome Measures

Change in glucose level as indicated by HbA1c levels [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.

Secondary Outcome Measures

Change in patient satisfaction with a multidisciplinary team approach management as indicated by a diabetes treatment satisfaction questionnaire (DTSQ) [baseline, 3 months]
Level of diabetes problem areas as assessed by the Problem Areas in Diabetes Questionnaire (PAID) questionnaire [baseline, 3 months]
Change in body mass index (BMI) [baseline, 3 months]
Change in weight [baseline, 3 months]
Change in blood pressure [baseline, 3 months]

Other Outcome Measures

Glucose level as indicated by HbA1c levels [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas Health Science Center at Houston	Houston	Texas	United States	77030

Sponsors and Collaborators

The University of Texas Health Science Center, Houston
DHR Health Institute for Research and Development

Investigators

Principal Investigator: Mayra J Cantu, The University of Texas Health Science Center, Houston

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mayra Judith Cantu, Family Nurse Practitioner, The University of Texas Health Science Center, Houston

ClinicalTrials.gov Identifier:

NCT03463629

Other Study ID Numbers:

HSC-SN-18-0075

First Posted:

Mar 13, 2018

Last Update Posted:

Sep 19, 2018

Last Verified:

Sep 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mayra Judith Cantu, Family Nurse Practitioner, The University of Texas Health Science Center, Houston

Multidisciplinary Team

Hispanic adults

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Sep 19, 2018