Skip to main content
OpenTrials
Completed

NCT Number: NCT03159533

Project IMPACT: CHW Intervention

The proposed study "Project IMPACT: CHW Intervention" is part of a larger study examining the efficacy, adoption, and impact of integrated EHR-based decision-support and physician feedback interventions with community health worker (CHW)-led self-management and coaching support for South Asian patients with uncontrolled hypertension. This is a randomized control intervention utilizing community health worker (CHW)-led self-management and coaching support for South Asian patients with uncontrolled hypertension at PCP clinics in New York City.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

About this study

The Goal of this study is that:

  • EHR-based decision support and performance feedback interventions will be more effective in improving hypertension control for South Asian patients than standard care;
  • A combined EHR-CHW intervention will be more effective in improving hypertension control for South Asian patients compared to standard care and the EHR-based intervention

Investigators hope to implement and assess the efficacy of CHW-led coaching through promotion of team-based care and use of culturally tailored education to improve hypertension control and mitigate risk factors related to CVD among South Asian patients with uncontrolled hypertension. Study findings can provide translatable and scalable models for other limited English proficient communities.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

CHW Intervention

  • Diagnosis of hypertension or at least two systolic blood pressure measurements of 140 mm Hg or greater, or at least two diastolic BP 90 mm Hg or greater in the past 12 months.

Focus Group

  • Any clinical patients meeting the inclusion criteria for the CHW Intervention who participated in the CHW Intervention Pilot Round.

Exclusion criteria

  • Pregnant patients are excluded.
  • No children or vulnerable subjects will be enrolled in this study.

Treatment and study plan

CHW intervention

Behavioral

Patients randomized to Group A will be invited to attend 4 more group educational sessions on self-management immediately.CHWs will follow up with participants by phone or in person through a home or clinic visit. At these follow-up meetings, CHWs will engage in goal-setting activities regarding changes to health behaviors, medication adherence, or other issues related to hypertension control as identified jointly by the patient and CHW. CHWs will also collect height, weight, and blood pressure measurements at initial and in-person follow-up visits. The CHW will make necessary referrals to other services available in the community (i.e. exercise classes, social services, mental health, tobacco cessation, etc.).

Wait list control group

Behavioral

4 education sessions beginning 6-12 months later.

Primary outcomes

  1. Percent of current diagnosed hypertensive patients with BP <140/90 (or BP<130/80 for patients with diabetes) at 6 Months

    Time frame: 6 Months

  2. Percent of current diagnosed hypertensive patients with BP <140/90 (or BP<130/80 for patients with diabetes) at 12 months

    Time frame: 12 months

  3. Percent of patients with HbA1c <7 (for patients with hypertension + diabetes) at 6 months

    Time frame: 6 months

Secondary outcomes

  1. Percent of patients with diagnosis of hypertension with a BP measure taken in the past 6 months

    Time frame: 6 months

  2. Percent of patients without hypertension having valid BP measurement, last 12 months

    Time frame: 12 months

  3. Percent of current hypertensive patients screened for diabetes in last year

    Time frame: 12 months

  4. Percent of current hypertensive patients receiving counseling on BMI, diet and physical activity

    Time frame: 12 months

  5. Percent of current diagnosed hypertensive patients referred to a nutritionist in the past year

    Time frame: 12 months

  6. Percent of current diagnosed hypertensive patients who smoke who have been referred for smoking cessation

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

Project IMPACT: Community Health Care Worker (CHW) Intervention

Acronym: IMPACT

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 18, 2017
Registry last updated
May 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.