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

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Specialized multidisciplinary diabetes team (SMDT) approach
Traditional model of care
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Multidisciplinary Team, Hispanic adults

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Specialized multidisciplinary diabetes team (SMDT) approach

Traditional model of care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
March 6, 2018
Last Updated
September 18, 2018
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
DHR Health Institute for Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT03463629
Brief Title
Multidisciplinary Team Approach: Working Together to Improve Glycemic Control in Hispanic Adults Diabetes
Official Title
Multidisciplinary Team Approach: Working Together to Improve Glycemic Control in Hispanic Adults With Uncontrolled Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
March 21, 2018 (Actual)
Primary Completion Date
August 14, 2018 (Actual)
Study Completion Date
August 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
DHR Health Institute for Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Multidisciplinary Team, Hispanic adults

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Specialized multidisciplinary diabetes team (SMDT) approach
Arm Type
Experimental
Arm Description
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.
Arm Title
Traditional model of care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Specialized multidisciplinary diabetes team (SMDT) approach
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Traditional model of care
Intervention Description
Receive the traditional model of care, but will not receive diabetes education by pharmacists or counseling services
Primary Outcome Measure Information:
Title
Change in glucose level as indicated by HbA1c levels
Description
In this outcome, only the specialized multidisciplinary diabetes team (SMDT) arm (and not the traditional model of care arm) will be assessed.
Time Frame
baseline, 3 months
Secondary Outcome Measure Information:
Title
Change in patient satisfaction with a multidisciplinary team approach management as indicated by a diabetes treatment satisfaction questionnaire (DTSQ)
Time Frame
baseline, 3 months
Title
Level of diabetes problem areas as assessed by the Problem Areas in Diabetes Questionnaire (PAID) questionnaire
Time Frame
baseline, 3 months
Title
Change in body mass index (BMI)
Time Frame
baseline, 3 months
Title
Change in weight
Time Frame
baseline, 3 months
Title
Change in blood pressure
Time Frame
baseline, 3 months
Other Pre-specified Outcome Measures:
Title
Glucose level as indicated by HbA1c levels
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mayra J Cantu
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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

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