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

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ClinicalTrials.gov Identifier: NCT03463629
Recruitment Status : Completed
First Posted : March 13, 2018
Last Update Posted : September 19, 2018
Sponsor:
Collaborator:
Doctors Hospital at Renaissance
Information provided by (Responsible Party):
Mayra Judith Cantu, The University of Texas Health Science Center, Houston

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
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 : March 21, 2018
Actual Primary Completion Date : August 14, 2018
Actual Study Completion Date : August 14, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in patient satisfaction with a multidisciplinary team approach management as indicated by a diabetes treatment satisfaction questionnaire (DTSQ) [ Time Frame: baseline, 3 months ]
  2. Level of diabetes problem areas as assessed by the Problem Areas in Diabetes Questionnaire (PAID) questionnaire [ Time Frame: baseline, 3 months ]
  3. Change in body mass index (BMI) [ Time Frame: baseline, 3 months ]
  4. Change in weight [ Time Frame: baseline, 3 months ]
  5. Change in blood pressure [ Time Frame: baseline, 3 months ]

Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03463629


Locations
United States, Texas
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
Doctors Hospital at Renaissance
Investigators
Principal Investigator: Mayra J Cantu The University of Texas Health Science Center, Houston

Responsible Party: Mayra Judith Cantu, Family Nurse Practitioner, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03463629     History of Changes
Other Study ID Numbers: HSC-SN-18-0075
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: September 2018

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

Keywords provided by Mayra Judith Cantu, The University of Texas Health Science Center, Houston:
Multidisciplinary Team
Hispanic adults

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases