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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
98
Intensive Diabetes Self-Management Education and Support combined with Addressing Social Determinants of Health
Standard of Care for patients with type 2 diabetes
St. Vincent House Clinic
Galveston, Texas, United States
Change from baseline HbA1c
measurement of hemoglobin A1c (HbA1c %)
Time frame: at 6 months
Change from baseline HbA1c
measurement of hemoglobin A1c (HbA1c %)
Time frame: at 12 months
Change from baseline weight
measurement of body weight in Kg
Time frame: at 6 months
Change from baseline weight
measurement of body weight in Kg
Time frame: at 12 months
Change from baseline blood pressure
measurement of systolic and diastolic blood pressure in mm Hg
Time frame: at 6 months
Change from baseline blood pressure
measurement of systolic and diastolic blood pressure in mm Hg
Time frame: at 12 months
Change from baseline lipid profile
measurement of lipid profile: Total Cholesterol, Triglycerides, High-Density Lipoprotein, and Low-Density Lipoprotein in mg/dL
Time frame: at 6 months
Change from baseline lipid profile
measurement of lipid profile: Total Cholesterol, Triglycerides, High-Density Lipoprotein, and Low-Density Lipoprotein in mg/dL
Time frame: at 12 months
Change from baseline frequency of provider encounter
Frequency of provider encounter
Time frame: at 6 months
Change from baseline frequency of provider encounter
Frequency of provider encounter
Time frame: at 12 months
Change from baseline frequency of feet examination for neuropathy
Frequency of feet examination for neuropathy
Time frame: at 6 months
Change from baseline frequency of feet examination for neuropathy
Frequency of feet examination for neuropathy
Time frame: at 12 months
Change from baseline frequency of urine exam for microalbuminuria
Frequency of urine exam for microalbuminuria
Time frame: at 6 months
Change from baseline frequency of urine exam for microalbuminuria
Frequency of urine exam for microalbuminuria
Time frame: at 12 months
Change from baseline frequency of oral health checkup
Frequency of oral health checkup
Time frame: at 6 months
Change from baseline frequency of oral health checkup
Frequency of oral health checkup
Time frame: at 12 months
Change from baseline frequency of eye fundus examination
Frequency of eye fundus examination
Time frame: at 6 months
Change from baseline frequency of eye fundus examination
Frequency of eye fundus examination
Time frame: at 12 months
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
Time frame: at 6 months
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
Time frame: at 12 months
Change from baseline frequency of hospitalizations and re-admissions
Frequency of hospitalizations and re-admissions
Time frame: at 6 months
Change from baseline frequency of hospitalizations and re-admissions
Frequency of hospitalizations and re-admissions
Time frame: at 12 months
Participation in iDSMES classes (for those in the intervention arm only)
Participation in iDSMES classes (total number of sessions attended)
Time frame: at 12 months
Lifestyle change outcomes (for those in the intervention arm only)
Physical activity minutes in the last week prior to session
Time frame: every session through study completion, an average of 1 year
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".
Time frame: at 6 months
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".
Time frame: at 12 months
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.
Time frame: at 6 months
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.
Time frame: at 12 months
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).
Time frame: at 6 months
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).
Time frame: at 12 months
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".
Time frame: at 6 months
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".
Time frame: at 12 months
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.
Time frame: at 6 months
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.
Time frame: at 12 months
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