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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
450
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.
Participants will attend only the first group-based health education session on hypertension and diabetes management.
NYU Langone Health
New York, New York, United States
Percent of participants achieving BP control, defined as <130/80 mmHg
The primary outcome will be the proportion of eligible patients at a practice site to achieve BP control (130/80 mmHg) at six months.
Time frame: Month 6
Percent of participants achieving BP control, defined as <130/80 mmHg
The primary outcome will be the proportion of eligible patients at a practice site to achieve BP control (130/80 mmHg) at twelve months.
Time frame: Month 12
Change from Baseline in hemoglobin A1c (HbA1c) levels at Month 6
Change in HbA1c will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.
Time frame: Baseline, Month 6
Change from Baseline in HbA1c levels at Month 12
Change in HbA1c will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.
Time frame: Baseline, Month 12
Change from Baseline in Body mass index (BMI) at Month 6
Change in BMI will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.
Time frame: Baseline, Month 6
Change from Baseline in BMI at Month 12
Change in BMI will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.
Time frame: Baseline, Month 12
Change from Baseline in Systolic blood pressure (SBP) at Month 6
Change in SBP will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.
Time frame: Baseline, Month 6
Change from Baseline in SBP at Month 12
Change in SBP will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.
Time frame: Baseline, Month 12
Change from Baseline in Diastolic blood pressure (DBP) at Month 6
Change in DBP will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.
Time frame: Baseline, Month 6
Change from Baseline in DBP at Month 12
Change in DBP will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.
Time frame: Baseline, Month 12
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