Type 2 DiabetesNCT03463629
Multidisciplinary Team Approach: Working Together to Improve Glycemic Control in Hispanic Adults Diabetes
A study testing Specialized multidisciplinary diabetes team (SMDT) approach and Traditional model of care in people with Type 2 Diabetes, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Specialized multidisciplinary diabetes team (SMDT) approach and Traditional model of care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2018to 14 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Multidisciplinary Team Approach: Working Together to Improve Glycemic Control in Hispanic Adults With Uncontrolled Type 2 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Specialized multidisciplinary diabetes team (SMDT) approach, Traditional model of care
- Keywords
- Multidisciplinary Team, Hispanic adults
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specialized multidisciplinary diabetes team (SMDT) approachOther
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 careOther
Receive the traditional model of care, but will not receive diabetes education by pharmacists or counseling services
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Traditional model of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: baseline, 3 months
Level of diabetes problem areas as assessed by the Problem Areas in Diabetes Questionnaire (PAID) questionnaire
Measured: baseline, 3 months
Change in body mass index (BMI)
Measured: baseline, 3 months
Change in weight
Measured: baseline, 3 months
Change in blood pressure
Measured: baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start21 Mar 2018
- Primary completion14 Aug 2018
- Study completion14 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- DHR Health Institute for Research and Development
- Responsible party
- Principal investigator, Mayra Judith Cantu, The University of Texas Health Science Center, Houston
- Investigators
- Mayra J Cantu, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03463629
- Sponsor's protocol ID
- HSC-SN-18-0075
- Status last verified
- Sep 2018
- First submitted
- 6 Mar 2018
- Last updated
- 19 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidisciplinary Team Approach: Working Together to Improve Glycemic Control in Hispanic Adults With Uncontrolled Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03463629
- Acronym / sponsor ID
- HSC-SN-18-0075
- Conditions
- Type 2 Diabetes
- Keywords
- Multidisciplinary Team, Hispanic adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- DHR Health Institute for Research and Development
- Study start
- 21 Mar 2018 (actual)
- Primary completion
- 14 Aug 2018 (actual)
- Study completion
- 14 Aug 2018 (actual)
- First posted
- 13 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Specialized multidisciplinary diabetes team (SMDT) approach | Experimental | Other: Specialized multidisciplinary diabetes team (SMDT) approachThe 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 comparator | Other: Traditional model of careReceive 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specialized multidisciplinary diabetes team (SMDT) approachThe 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 careReceive the traditional model of care, but will not receive diabetes education by pharmacists or counseling services | Other | Traditional model of care |
Primary outcome
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.
5 secondary outcomes
Change in patient satisfaction with a multidisciplinary team approach management as indicated by a diabetes treatment satisfaction questionnaire (DTSQ)
Time frame: baseline, 3 months
Level of diabetes problem areas as assessed by the Problem Areas in Diabetes Questionnaire (PAID) questionnaire
Time frame: baseline, 3 months
Change in body mass index (BMI)
Time frame: baseline, 3 months
Change in weight
Time frame: baseline, 3 months
Change in blood pressure
Time frame: baseline, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mayra J Cantu principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specialized multidisciplinary diabetes team (SMDT) approach and Traditional model of care in people with Type 2 Diabetes, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glucose level as indicated by HbA1c levels (time frame: baseline, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2018.