N/A
N=195
Scaling Community-Clinical Linkage Models to Address Diabetes and Hypertension Disparities in the Southeast United States
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT04263311 ↗Enrolled (actual)
195
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Percentage of Patients Who Achieve Blood Pressure (BP) Control. — 40.2; 24.2 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CHW (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Who Achieve Blood Pressure (BP) Control. |
40.2; 24.2 | — |
| SECONDARY Change in Haemoglobin A1c (HbA1c) |
6.7; 6.9 | — |
| SECONDARY Systolic Blood Pressure (SBP) |
126.1; 132.5 | — |
| SECONDARY Diastolic Blood Pressure (DBP) |
76.8; 81.0 | — |
| SECONDARY Body Mass Index (BMI) |
26.8; 26.7 | — |
Summary
The purpose of this study is to work with primary care physicians and their staff, and with community health workers (CHWs) to improve diabetes and hypertension management, health behaviors and improve blood pressure for South Asian patients with uncontrolled diabetes and hypertension in primary care clinics in Atlanta, Georgia. The CHWs are community members who are trained to work with patients to address health needs holistically by providing information on wellness, nutrition, stress relief, and blood pressure management in a culturally-appropriate and language-appropriate manner.
Eligibility Criteria
CHW intervention:
Inclusion Criteria
- identified as of South Asian ethnicity
- are at least 21 years of age and younger than age 80
- had an appointment with a physician or mid-level clinician for routine non-emergent primary care in the last 12 months
- a diagnosis of diabetes
- a diagnosis of hypertension
- an uncontrolled BP reading (>130/80mmHg) in the last 6 months
Provider Surveys Inclusion criteria
- clinicians employed by the clinic
- have enrolled into the study.
Key Informant Interviews Inclusion criteria
- must be a provider, clinic manager, or community health worker.
CHW intervention
Exclusion Criteria
- under the age of 21 and older than 80
- pregnant
- Type 1 diabetes or diabetes secondary to other conditions
- malignancy or life threatening illness with life expectancy of <5 years
- inability to perform unsupervised physical activity
- diagnosed cognitive deficits or limited decision-making capacity
Provider Surveys Inclusion criteria
- clinicians who are unable to complete the survey in the English language.
Key Informant Interviews Inclusion criteria
- who are unable to participate in the interview conducted in the English language.
Data sourced from ClinicalTrials.gov (NCT04263311). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.