NCT03463629

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 13, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

March 21, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2018

Completed
Last Updated

September 19, 2018

Status Verified

September 1, 2018

Enrollment Period

5 months

First QC Date

March 6, 2018

Last Update Submit

September 18, 2018

Conditions

Keywords

Multidisciplinary TeamHispanic adults

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

EXPERIMENTAL

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

Traditional model of care

ACTIVE COMPARATOR

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

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.

Specialized multidisciplinary diabetes team (SMDT) approach

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

Traditional model of care

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Mayra J Cantu

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

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

Locations