Diabetes Mellitus Type II, Hypertension
Conditions
Brief summary
The purpose of this study is to test the effectiveness and implementation process of a culturally and contextually tailored telehealth-based community health workers (CHW) led coaching intervention for hypertension control among South Asian patients with co-morbid Diabetes Mellitus type II (DMII) and hypertension. The primary aims are to test the effectiveness of a CHW-led telehealth intervention compared to usual care, and using Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) and Consolidated Framework for Implementation Research (CFIR), examine the reach, adoption, fidelity, and maintenance of the intervention within clinical and community settings.
Interventions
BEHAVIORALIntegrated CHW Intervention
Participants will undergo all 5 group-based health education sessions on hypertension and diabetes management and provide culturally and linguistically tailored health information and resources. There will be two one-on-one virtual meetings, up to 9 follow-up phone calls to engage in goal-setting activities regarding changes to health behaviors, medication adherence, or other issues related to diabetes prevention as identified jointly by patient and CHW. Participants will develop with the CHW and receive a copy of their long-term and short-term Participant Action Plan. Referrals to other services available in the community (i.e. exercise classes, social services, mental health, tobacco cessation, etc.
BEHAVIORALCHW Session 1 Only
Participants will attend only the first group-based health education session on hypertension and diabetes management.
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* identified as of South Asian ethnicity * at least 21 years of age * a diagnosis of diabetes * a diagnosis of hypertension * an uncontrolled BP reading (\>130/80mmHg) in the last 6 months
Exclusion criteria
* under the age of 21 * Women who are pregnant * Type 1 diabetes or diabetes secondary to other conditions (e.g. steroid-induced, pancreatic insufficiency, or chemotherapy-induced) * inability to perform unsupervised physical activity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of participants achieving BP control, defined as <130/80 mmHg | Month 6 | The primary outcome will be the proportion of eligible patients at a practice site to achieve BP control (130/80 mmHg) at six months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of participants achieving BP control, defined as <130/80 mmHg | Month 12 | The primary outcome will be the proportion of eligible patients at a practice site to achieve BP control (130/80 mmHg) at twelve months. |
| Change from Baseline in hemoglobin A1c (HbA1c) levels at Month 6 | Baseline, Month 6 | Change in HbA1c will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR. |
| Change from Baseline in Body mass index (BMI) at Month 6 | Baseline, Month 6 | Change in BMI will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR. |
| Change from Baseline in BMI at Month 12 | Baseline, Month 12 | Change in BMI will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR. |
| Change from Baseline in HbA1c levels at Month 12 | Baseline, Month 12 | Change in HbA1c will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR. |
| Change from Baseline in SBP at Month 12 | Baseline, Month 12 | Change in SBP will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR. |
| Change from Baseline in Diastolic blood pressure (DBP) at Month 6 | Baseline, Month 6 | Change in DBP will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR. |
| Change from Baseline in DBP at Month 12 | Baseline, Month 12 | Change in DBP will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR. |
| Change from Baseline in Systolic blood pressure (SBP) at Month 6 | Baseline, Month 6 | Change in SBP will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR. |
Countries
United States
Outcome results
None listed