Clinical trial NCT05097534: 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
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2021-10-28
Enrollment: 150
Sex: ALL
Minimum age (years): 13
Maximum age (years): 84
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline HbA1c
timeFrame: at 6 months
measure: Change from baseline HbA1c
timeFrame: at 12 months
Secondary outcomes:
measure: Change from baseline weight
timeFrame: at 6 months
measure: Change from baseline weight
timeFrame: at 12 months
measure: Change from baseline blood pressure
timeFrame: at 6 months
measure: Change from baseline blood pressure
timeFrame: at 12 months
measure: Change from baseline lipid profile
timeFrame: at 6 months
measure: Change from baseline lipid profile
timeFrame: at 12 months
measure: Change from baseline frequency of provider encounter
timeFrame: at 6 months
measure: Change from baseline frequency of provider encounter
timeFrame: at 12 months
measure: Change from baseline frequency of feet examination for neuropathy
timeFrame: at 6 months
measure: Change from baseline frequency of feet examination for neuropathy
timeFrame: at 12 months
measure: Change from baseline frequency of urine exam for microalbuminuria
timeFrame: at 6 months
measure: Change from baseline frequency of urine exam for microalbuminuria
timeFrame: at 12 months
measure: Change from baseline frequency of oral health checkup
timeFrame: at 6 months
measure: Change from baseline frequency of oral health checkup
timeFrame: at 12 months
measure: Change from baseline frequency of eye fundus examination
timeFrame: at 6 months
measure: Change from baseline frequency of eye fundus examination
timeFrame: at 12 months
measure: Change from baseline frequency of emergency care visits for treatment of T2-related issues
timeFrame: at 6 months
measure: Change from baseline frequency of emergency care visits for treatment of T2-related issues
timeFrame: at 12 months
measure: Change from baseline frequency of hospitalizations and re-admissions
timeFrame: at 6 months
measure: Change from baseline frequency of hospitalizations and re-admissions
timeFrame: at 12 months
measure: Participation in iDSMES classes (for those in the intervention arm only)
timeFrame: at 12 months
measure: Lifestyle change outcomes (for those in the intervention arm only)
timeFrame: every session through study completion, an average of 1 year
measure: Change from baseline patient-centeredness
timeFrame: at 6 months
measure: Change from baseline patient-centeredness
timeFrame: at 12 months
measure: Change from baseline secondary diabetes self-management behaviors
timeFrame: at 6 months
measure: Change from baseline secondary diabetes self-management behaviors
timeFrame: at 12 months
measure: Change from baseline self-efficacy in managing diabetes
timeFrame: at 6 months
measure: Change from baseline self-efficacy in managing diabetes
timeFrame: at 12 months
measure: Change from baseline diabetes distress
timeFrame: at 6 months
measure: Change from baseline diabetes distress
timeFrame: at 12 months
measure: Change from baseline medication Adherence
timeFrame: at 6 months
measure: Change from baseline medication Adherence
timeFrame: at 12 months
Other outcomes:
Locations:
city: Galveston
country: United States
facility: St. Vincent House Clinic
state: Texas
Study officials:
References: