Multidisciplinary Team Approach: Working Together to Improve Glycemic Control in Hispanic Adults Diabetes
1 other identifier
interventional
33
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable type-2-diabetes
Started Mar 2018
Shorter than P25 for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2018
CompletedFirst Posted
Study publicly available on registry
March 13, 2018
CompletedStudy Start
First participant enrolled
March 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 14, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 14, 2018
CompletedSeptember 19, 2018
September 1, 2018
5 months
March 6, 2018
September 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
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 Outcomes (1)
Glucose level as indicated by HbA1c levels
3 months
Study Arms (2)
Specialized multidisciplinary diabetes team (SMDT) approach
EXPERIMENTALThe 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
ACTIVE COMPARATORReceive 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mayra J Cantu
The University of Texas Health Science Center, Houston
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Family Nurse Practitioner
Study Record Dates
First Submitted
March 6, 2018
First Posted
March 13, 2018
Study Start
March 21, 2018
Primary Completion
August 14, 2018
Study Completion
August 14, 2018
Last Updated
September 19, 2018
Record last verified: 2018-09