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Completed

NCT Number: NCT03463629

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Specialized multidisciplinary diabetes team (SMDT) approach

Other

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

Other

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

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • DHR Health Institute for Research and Development

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 13, 2018
Registry last updated
Sep 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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