A Comprehensive Community Approach for Diabetes Prevention and Care for a Vulnerable Population in Galveston

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Comprehensive Community Approach for Diabetes Prevention and Care for a Vulnerable Population in Galveston

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05097534
• Other study ID #: 21-0194
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 7, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 84 Years

Eligibility

Inclusion Criteria:

1. Patients aged 13-84, and

2. Patients diagnosed with type 2 diabetes, and

3. Patients have a BMI equal to or >25 (23, if Asians), and

4. Hemoglobin A1c value equal to or >7%

Exclusion Criteria:

1. Ages <13 or >84

2. Pregnancy. If a subject becomes pregnant, they will advised to discontinue the study.

3. Previous diagnosis of type 1 diabetes

4. 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

5. Other medical condition or medication administration deemed exclusionary by the study investigators

6. Prisoners

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Other:
• iDSMES
Intensive Diabetes Self-Management Education and Support combined with Addressing Social Determinants of Health
• Standard of Care
Standard of Care for patients with type 2 diabetes

Locations

Country	Name	City	State
United States	St. Vincent House Clinic	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline HbA1c	measurement of hemoglobin A1c (HbA1c %)	at 6 months
Primary	Change from baseline HbA1c	measurement of hemoglobin A1c (HbA1c %)	at 12 months
Secondary	Change from baseline weight	measurement of body weight in Kg	at 6 months
Secondary	Change from baseline weight	measurement of body weight in Kg	at 12 months
Secondary	Change from baseline blood pressure	measurement of systolic and diastolic blood pressure in mm Hg	at 6 months
Secondary	Change from baseline blood pressure	measurement of systolic and diastolic blood pressure in mm Hg	at 12 months
Secondary	Change from baseline lipid profile	measurement of lipid profile: Total Cholesterol, Triglycerides, High-Density Lipoprotein, and Low-Density Lipoprotein in mg/dL	at 6 months
Secondary	Change from baseline lipid profile	measurement of lipid profile: Total Cholesterol, Triglycerides, High-Density Lipoprotein, and Low-Density Lipoprotein in mg/dL	at 12 months
Secondary	Change from baseline frequency of provider encounter	Frequency of provider encounter	at 6 months
Secondary	Change from baseline frequency of provider encounter	Frequency of provider encounter	at 12 months
Secondary	Change from baseline frequency of feet examination for neuropathy	Frequency of feet examination for neuropathy	at 6 months
Secondary	Change from baseline frequency of feet examination for neuropathy	Frequency of feet examination for neuropathy	at 12 months
Secondary	Change from baseline frequency of urine exam for microalbuminuria	Frequency of urine exam for microalbuminuria	at 6 months
Secondary	Change from baseline frequency of urine exam for microalbuminuria	Frequency of urine exam for microalbuminuria	at 12 months
Secondary	Change from baseline frequency of oral health checkup	Frequency of oral health checkup	at 6 months
Secondary	Change from baseline frequency of oral health checkup	Frequency of oral health checkup	at 12 months
Secondary	Change from baseline frequency of eye fundus examination	Frequency of eye fundus examination	at 6 months
Secondary	Change from baseline frequency of eye fundus examination	Frequency of eye fundus examination	at 12 months
Secondary	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	at 6 months
Secondary	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	at 12 months
Secondary	Change from baseline frequency of hospitalizations and re-admissions	Frequency of hospitalizations and re-admissions	at 6 months
Secondary	Change from baseline frequency of hospitalizations and re-admissions	Frequency of hospitalizations and re-admissions	at 12 months
Secondary	Participation in iDSMES classes (for those in the intervention arm only)	Participation in iDSMES classes (total number of sessions attended)	at 12 months
Secondary	Lifestyle change outcomes (for those in the intervention arm only)	Physical activity minutes in the last week prior to session	every session through study completion, an average of 1 year
Secondary	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".	at 6 months
Secondary	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".	at 12 months
Secondary	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.	at 6 months
Secondary	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.	at 12 months
Secondary	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).	at 6 months
Secondary	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).	at 12 months
Secondary	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".	at 6 months
Secondary	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".	at 12 months
Secondary	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.	at 6 months
Secondary	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.	at 12 months