Back to resultsA Comprehensive Community Approach for Diabetes Prevention and Care for a Vulnerable Population in Galveston
Primary Purpose
Diabetes Mellitus, Type 2
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iDSMES
Standard of Care
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria:
- Patients aged 13-84, and
- Patients diagnosed with type 2 diabetes, and
- Patients have a BMI equal to or >25 (23, if Asians), and
- Hemoglobin A1c value equal to or >7%
Exclusion Criteria:
- Ages <13 or >84
- Pregnancy. If a subject becomes pregnant, they will advised to discontinue the study.
- Previous diagnosis of type 1 diabetes
- Inability to participate for 12-month duration (e.g., Disorders that might compromise survival, planning to relocate outside the geographical coverage of University of Texas Medical Branch (UTMB) clinics
- Other medical condition or medication administration deemed exclusionary by the study investigators
- Prisoners
Sites / Locations
- St. Vincent House Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
iDSMES
Standard of Care
Arm Description
Eligible study subjects randomized to the intervention arm will receive: A. Intensive Diabetes Self-Management, Education, and Support (iDSMES). Participants will be enrolled in groups in a virtual or in-person setting with their lifestyle coach, in this one-year educational program B. Services addressing Social Determinants of Health All study subjects will have their data collected at time points around baseline, 6 months and 12 months from consenting including glycemic control, hypertension management, dyslipidemia management, prevention or management of complications, healthcare outcomes, lifestyle change outcomes, patient-centeredness outcomes, Secondary diabetes self-management behaviors, self-efficacy in managing diabetes, diabetes distress, and Morisky Green Levine Medication Adherence Scale.
Eligible study subjects randomized to the intervention arm will receive standard of care offered to patients with diabetes.
Outcomes
Primary Outcome Measures
Change from baseline HbA1c
measurement of hemoglobin A1c (HbA1c %)
Change from baseline HbA1c
measurement of hemoglobin A1c (HbA1c %)
Secondary Outcome Measures
Change from baseline weight
measurement of body weight in Kg
Change from baseline weight
measurement of body weight in Kg
Change from baseline blood pressure
measurement of systolic and diastolic blood pressure in mm Hg
Change from baseline blood pressure
measurement of systolic and diastolic blood pressure in mm Hg
Change from baseline lipid profile
measurement of lipid profile: Total Cholesterol, Triglycerides, High-Density Lipoprotein, and Low-Density Lipoprotein in mg/dL
Change from baseline lipid profile
measurement of lipid profile: Total Cholesterol, Triglycerides, High-Density Lipoprotein, and Low-Density Lipoprotein in mg/dL
Change from baseline frequency of provider encounter
Frequency of provider encounter
Change from baseline frequency of provider encounter
Frequency of provider encounter
Change from baseline frequency of feet examination for neuropathy
Frequency of feet examination for neuropathy
Change from baseline frequency of feet examination for neuropathy
Frequency of feet examination for neuropathy
Change from baseline frequency of urine exam for microalbuminuria
Frequency of urine exam for microalbuminuria
Change from baseline frequency of urine exam for microalbuminuria
Frequency of urine exam for microalbuminuria
Change from baseline frequency of oral health checkup
Frequency of oral health checkup
Change from baseline frequency of oral health checkup
Frequency of oral health checkup
Change from baseline frequency of eye fundus examination
Frequency of eye fundus examination
Change from baseline frequency of eye fundus examination
Frequency of eye fundus examination
Change from baseline frequency of emergency care visits for treatment of T2-related issues
Frequency of emergency care visits for treatment of T2-related issues
Change from baseline frequency of emergency care visits for treatment of T2-related issues
Frequency of emergency care visits for treatment of T2-related issues
Change from baseline frequency of hospitalizations and re-admissions
Frequency of hospitalizations and re-admissions
Change from baseline frequency of hospitalizations and re-admissions
Frequency of hospitalizations and re-admissions
Participation in iDSMES classes (for those in the intervention arm only)
Participation in iDSMES classes (total number of sessions attended)
Lifestyle change outcomes (for those in the intervention arm only)
Physical activity minutes in the last week prior to session
Change from baseline patient-centeredness
General self-rated Health (GSRH): a single item survey- self-administered single question such as "in general, would you say that your health is? excellent, very good, good, fair, or poor?", where excellent is scored as "5" and poor is scored as "0".
Change from baseline patient-centeredness
General self-rated Health (GSRH): a single item survey- self-administered single question such as "in general, would you say that your health is? excellent, very good, good, fair, or poor?", where excellent is scored as "5" and poor is scored as "0".
Change from baseline secondary diabetes self-management behaviors
fifty-six-item survey. This includes a series of secondary diabetes self-management behaviors to explore mediating factors that might influence changes in glycemic control. We will assess the proportion of individuals with severe hypoglycemic episodes and use the brief modified Block seven-item diet screener with a four-week time horizon to determine the number of servings per day of fruit and vegetables.
Change from baseline secondary diabetes self-management behaviors
fifty-six-item survey. This includes a series of secondary diabetes self-management behaviors to explore mediating factors that might influence changes in glycemic control. We will assess the proportion of individuals with severe hypoglycemic episodes and use the brief modified Block seven-item diet screener with a four-week time horizon to determine the number of servings per day of fruit and vegetables.
Change from baseline self-efficacy in managing diabetes
This self-management resource center validated eight-item survey on patient confidence in performing certain activities. The survey is scored from 0 to 10 on a visual analog scale (VAS).
Change from baseline self-efficacy in managing diabetes
This self-management resource center validated eight-item survey on patient confidence in performing certain activities. The survey is scored from 0 to 10 on a visual analog scale (VAS).
Change from baseline diabetes distress
a two-item screening tool on 17 potential problems in the life of patients with diabetes. Patients are asked to score the distress ensuing from each problem during the last month from 1 to 6, where 1 is "Not a problem" and 6 is "a very serious problem".
Change from baseline diabetes distress
a two-item screening tool on 17 potential problems in the life of patients with diabetes. Patients are asked to score the distress ensuing from each problem during the last month from 1 to 6, where 1 is "Not a problem" and 6 is "a very serious problem".
Change from baseline medication Adherence
"Morisky Green Levine" Medication Adherence Scale: a four-item tool queries about forgetfulness, carelessness, and feelings around taking medications, scored from 0 to 4.
Change from baseline medication Adherence
"Morisky Green Levine" Medication Adherence Scale: a four-item tool queries about forgetfulness, carelessness, and feelings around taking medications, scored from 0 to 4.
Full Information
NCT ID
NCT05097534
First Posted
September 22, 2021
Last Updated
January 19, 2023
Sponsor
The University of Texas Medical Branch, Galveston
1. Study Identification
Unique Protocol Identification Number
NCT05097534
Brief Title
A Comprehensive Community Approach for Diabetes Prevention and Care for a Vulnerable Population in Galveston
Official Title
A Comprehensive Community Approach for Diabetes Prevention and Care for a Vulnerable Population in Galveston
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 7, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To improve diabetes self-management outcomes, patients with type 2 diabetes (n=150 - aged 13-84) recruited from St. Vincent Clinic (SVC) and Teen Health Center Inc., Clinics will be randomized using block randomization to receive standard of care or the integrated model. Patients in the intervention arm will be assessed for social and physical needs before being enrolled in a year-long education program (iDSMES). Enrollees will receive dietary counseling, physical and occupational therapy, in addition to other mental, financial and social benefits counseling. The investigators will compare the intervention outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
iDSMES
Arm Type
Active Comparator
Arm Description
Eligible study subjects randomized to the intervention arm will receive:
A. Intensive Diabetes Self-Management, Education, and Support (iDSMES). Participants will be enrolled in groups in a virtual or in-person setting with their lifestyle coach, in this one-year educational program B. Services addressing Social Determinants of Health All study subjects will have their data collected at time points around baseline, 6 months and 12 months from consenting including glycemic control, hypertension management, dyslipidemia management, prevention or management of complications, healthcare outcomes, lifestyle change outcomes, patient-centeredness outcomes, Secondary diabetes self-management behaviors, self-efficacy in managing diabetes, diabetes distress, and Morisky Green Levine Medication Adherence Scale.
Arm Title
Standard of Care
Arm Type
Placebo Comparator
Arm Description
Eligible study subjects randomized to the intervention arm will receive standard of care offered to patients with diabetes.
Intervention Type
Other
Intervention Name(s)
iDSMES
Intervention Description
Intensive Diabetes Self-Management Education and Support combined with Addressing Social Determinants of Health
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Standard of Care for patients with type 2 diabetes
Primary Outcome Measure Information:
Title
Change from baseline HbA1c
Description
measurement of hemoglobin A1c (HbA1c %)
Time Frame
at 6 months
Title
Change from baseline HbA1c
Description
measurement of hemoglobin A1c (HbA1c %)
Time Frame
at 12 months
Secondary Outcome Measure Information:
Title
Change from baseline weight
Description
measurement of body weight in Kg
Time Frame
at 6 months
Title
Change from baseline weight
Description
measurement of body weight in Kg
Time Frame
at 12 months
Title
Change from baseline blood pressure
Description
measurement of systolic and diastolic blood pressure in mm Hg
Time Frame
at 6 months
Title
Change from baseline blood pressure
Description
measurement of systolic and diastolic blood pressure in mm Hg
Time Frame
at 12 months
Title
Change from baseline lipid profile
Description
measurement of lipid profile: Total Cholesterol, Triglycerides, High-Density Lipoprotein, and Low-Density Lipoprotein in mg/dL
Time Frame
at 6 months
Title
Change from baseline lipid profile
Description
measurement of lipid profile: Total Cholesterol, Triglycerides, High-Density Lipoprotein, and Low-Density Lipoprotein in mg/dL
Time Frame
at 12 months
Title
Change from baseline frequency of provider encounter
Description
Frequency of provider encounter
Time Frame
at 6 months
Title
Change from baseline frequency of provider encounter
Description
Frequency of provider encounter
Time Frame
at 12 months
Title
Change from baseline frequency of feet examination for neuropathy
Description
Frequency of feet examination for neuropathy
Time Frame
at 6 months
Title
Change from baseline frequency of feet examination for neuropathy
Description
Frequency of feet examination for neuropathy
Time Frame
at 12 months
Title
Change from baseline frequency of urine exam for microalbuminuria
Description
Frequency of urine exam for microalbuminuria
Time Frame
at 6 months
Title
Change from baseline frequency of urine exam for microalbuminuria
Description
Frequency of urine exam for microalbuminuria
Time Frame
at 12 months
Title
Change from baseline frequency of oral health checkup
Description
Frequency of oral health checkup
Time Frame
at 6 months
Title
Change from baseline frequency of oral health checkup
Description
Frequency of oral health checkup
Time Frame
at 12 months
Title
Change from baseline frequency of eye fundus examination
Description
Frequency of eye fundus examination
Time Frame
at 6 months
Title
Change from baseline frequency of eye fundus examination
Description
Frequency of eye fundus examination
Time Frame
at 12 months
Title
Change from baseline frequency of emergency care visits for treatment of T2-related issues
Description
Frequency of emergency care visits for treatment of T2-related issues
Time Frame
at 6 months
Title
Change from baseline frequency of emergency care visits for treatment of T2-related issues
Description
Frequency of emergency care visits for treatment of T2-related issues
Time Frame
at 12 months
Title
Change from baseline frequency of hospitalizations and re-admissions
Description
Frequency of hospitalizations and re-admissions
Time Frame
at 6 months
Title
Change from baseline frequency of hospitalizations and re-admissions
Description
Frequency of hospitalizations and re-admissions
Time Frame
at 12 months
Title
Participation in iDSMES classes (for those in the intervention arm only)
Description
Participation in iDSMES classes (total number of sessions attended)
Time Frame
at 12 months
Title
Lifestyle change outcomes (for those in the intervention arm only)
Description
Physical activity minutes in the last week prior to session
Time Frame
every session through study completion, an average of 1 year
Title
Change from baseline patient-centeredness
Description
General self-rated Health (GSRH): a single item survey- self-administered single question such as "in general, would you say that your health is? excellent, very good, good, fair, or poor?", where excellent is scored as "5" and poor is scored as "0".
Time Frame
at 6 months
Title
Change from baseline patient-centeredness
Description
General self-rated Health (GSRH): a single item survey- self-administered single question such as "in general, would you say that your health is? excellent, very good, good, fair, or poor?", where excellent is scored as "5" and poor is scored as "0".
Time Frame
at 12 months
Title
Change from baseline secondary diabetes self-management behaviors
Description
fifty-six-item survey. This includes a series of secondary diabetes self-management behaviors to explore mediating factors that might influence changes in glycemic control. We will assess the proportion of individuals with severe hypoglycemic episodes and use the brief modified Block seven-item diet screener with a four-week time horizon to determine the number of servings per day of fruit and vegetables.
Time Frame
at 6 months
Title
Change from baseline secondary diabetes self-management behaviors
Description
fifty-six-item survey. This includes a series of secondary diabetes self-management behaviors to explore mediating factors that might influence changes in glycemic control. We will assess the proportion of individuals with severe hypoglycemic episodes and use the brief modified Block seven-item diet screener with a four-week time horizon to determine the number of servings per day of fruit and vegetables.
Time Frame
at 12 months
Title
Change from baseline self-efficacy in managing diabetes
Description
This self-management resource center validated eight-item survey on patient confidence in performing certain activities. The survey is scored from 0 to 10 on a visual analog scale (VAS).
Time Frame
at 6 months
Title
Change from baseline self-efficacy in managing diabetes
Description
This self-management resource center validated eight-item survey on patient confidence in performing certain activities. The survey is scored from 0 to 10 on a visual analog scale (VAS).
Time Frame
at 12 months
Title
Change from baseline diabetes distress
Description
a two-item screening tool on 17 potential problems in the life of patients with diabetes. Patients are asked to score the distress ensuing from each problem during the last month from 1 to 6, where 1 is "Not a problem" and 6 is "a very serious problem".
Time Frame
at 6 months
Title
Change from baseline diabetes distress
Description
a two-item screening tool on 17 potential problems in the life of patients with diabetes. Patients are asked to score the distress ensuing from each problem during the last month from 1 to 6, where 1 is "Not a problem" and 6 is "a very serious problem".
Time Frame
at 12 months
Title
Change from baseline medication Adherence
Description
"Morisky Green Levine" Medication Adherence Scale: a four-item tool queries about forgetfulness, carelessness, and feelings around taking medications, scored from 0 to 4.
Time Frame
at 6 months
Title
Change from baseline medication Adherence
Description
"Morisky Green Levine" Medication Adherence Scale: a four-item tool queries about forgetfulness, carelessness, and feelings around taking medications, scored from 0 to 4.
Time Frame
at 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged 13-84, and
Patients diagnosed with type 2 diabetes, and
Patients have a BMI equal to or >25 (23, if Asians), and
Hemoglobin A1c value equal to or >7%
Exclusion Criteria:
Ages <13 or >84
Pregnancy. If a subject becomes pregnant, they will advised to discontinue the study.
Previous diagnosis of type 1 diabetes
Inability to participate for 12-month duration (e.g., Disorders that might compromise survival, planning to relocate outside the geographical coverage of University of Texas Medical Branch (UTMB) clinics
Other medical condition or medication administration deemed exclusionary by the study investigators
Prisoners
Facility Information:
Facility Name
St. Vincent House Clinic
City
Galveston
State/Province
Texas
ZIP/Postal Code
77550
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
A Comprehensive Community Approach for Diabetes Prevention and Care for a Vulnerable Population in Galveston
We'll reach out to this number within 24 hrs