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

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

Change from baseline weight [ Time Frame: at 6 months ]
measurement of body weight in Kg

Change from baseline weight [ Time Frame: at 12 months ]
measurement of body weight in Kg

Change from baseline blood pressure [ Time Frame: at 6 months ]
measurement of systolic and diastolic blood pressure in mm Hg

Change from baseline blood pressure [ Time Frame: at 12 months ]
measurement of systolic and diastolic blood pressure in mm Hg

Change from baseline lipid profile [ Time Frame: at 6 months ]
measurement of lipid profile: Total Cholesterol, Triglycerides, High-Density Lipoprotein, and Low-Density Lipoprotein in mg/dL

Change from baseline lipid profile [ Time Frame: at 12 months ]
measurement of lipid profile: Total Cholesterol, Triglycerides, High-Density Lipoprotein, and Low-Density Lipoprotein in mg/dL

Change from baseline frequency of provider encounter [ Time Frame: at 6 months ]
Frequency of provider encounter

Change from baseline frequency of provider encounter [ Time Frame: at 12 months ]
Frequency of provider encounter

Change from baseline frequency of feet examination for neuropathy [ Time Frame: at 6 months ]
Frequency of feet examination for neuropathy

Change from baseline frequency of feet examination for neuropathy [ Time Frame: at 12 months ]
Frequency of feet examination for neuropathy

Change from baseline frequency of urine exam for microalbuminuria [ Time Frame: at 6 months ]
Frequency of urine exam for microalbuminuria

Change from baseline frequency of urine exam for microalbuminuria [ Time Frame: at 12 months ]
Frequency of urine exam for microalbuminuria

Change from baseline frequency of oral health checkup [ Time Frame: at 6 months ]
Frequency of oral health checkup

Change from baseline frequency of oral health checkup [ Time Frame: at 12 months ]
Frequency of oral health checkup

Change from baseline frequency of eye fundus examination [ Time Frame: at 6 months ]
Frequency of eye fundus examination

Change from baseline frequency of eye fundus examination [ Time Frame: at 12 months ]
Frequency of eye fundus examination

Change from baseline frequency of emergency care visits for treatment of T2-related issues [ Time Frame: at 6 months ]
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 [ Time Frame: at 12 months ]
Frequency of emergency care visits for treatment of T2-related issues

Change from baseline frequency of hospitalizations and re-admissions [ Time Frame: at 6 months ]
Frequency of hospitalizations and re-admissions

Change from baseline frequency of hospitalizations and re-admissions [ Time Frame: at 12 months ]
Frequency of hospitalizations and re-admissions

Participation in iDSMES classes (for those in the intervention arm only) [ Time Frame: at 12 months ]
Participation in iDSMES classes (total number of sessions attended)

Lifestyle change outcomes (for those in the intervention arm only) [ Time Frame: every session through study completion, an average of 1 year ]
Physical activity minutes in the last week prior to session

Change from baseline patient-centeredness [ Time Frame: at 6 months ]
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 [ Time Frame: at 12 months ]
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 [ Time Frame: at 6 months ]
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 [ Time Frame: at 12 months ]
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 [ Time Frame: at 6 months ]
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 [ Time Frame: at 12 months ]
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 [ Time Frame: at 6 months ]
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 [ Time Frame: at 12 months ]
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 [ Time Frame: at 6 months ]
“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 [ Time Frame: at 12 months ]
“Morisky Green Levine” Medication Adherence Scale: a four-item tool queries about forgetfulness, carelessness, and feelings around taking medications, scored from 0 to 4.

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

January 24, 2023Comments OffClinicalTrials.gov | Endocrinology Clinical Trials | Endocrinology Studies | US National Library of Medicine
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