search
Back to results

Project IMPACT: CHW Intervention (IMPACT)

Primary Purpose

Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CHW Intervention
Wait List Control Group
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hypertension

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • New York University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

CHW Intervention

Control Group

Arm Description

CHW lead Sessions Session1: BP and the Cardiovascular System Session 2: Nutrition and food labels Session 3: Physical Activity and Stress Management Session 4: CVD Risk factors: cholesterol, blood sugar, & Smoking Session 5: Health Communication, Healthcare access & Review

Wait-list

Outcomes

Primary Outcome Measures

Percent of current diagnosed hypertensive patients with BP <140/90 (or BP<130/80 for patients with diabetes) at 6 Months
Percent of current diagnosed hypertensive patients with BP <140/90 (or BP<130/80 for patients with diabetes) at 12 months
Percent of patients with HbA1c <7 (for patients with hypertension + diabetes) at 6 months

Secondary Outcome Measures

Percent of patients with diagnosis of hypertension with a BP measure taken in the past 6 months
Percent of patients without hypertension having valid BP measurement, last 12 months
Percent of current hypertensive patients screened for diabetes in last year
Percent of current hypertensive patients receiving counseling on BMI, diet and physical activity
Percent of current diagnosed hypertensive patients referred to a nutritionist in the past year
Percent of current diagnosed hypertensive patients who smoke who have been referred for smoking cessation

Full Information

First Posted
April 13, 2017
Last Updated
May 15, 2020
Sponsor
NYU Langone Health
search

1. Study Identification

Unique Protocol Identification Number
NCT03159533
Brief Title
Project IMPACT: CHW Intervention
Acronym
IMPACT
Official Title
Project IMPACT: Community Health Care Worker (CHW) Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
March 9, 2017 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Step wedge design, whereby 5 groups of 3 practices will implement the intervention in phases.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
305 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CHW Intervention
Arm Type
Active Comparator
Arm Description
CHW lead Sessions Session1: BP and the Cardiovascular System Session 2: Nutrition and food labels Session 3: Physical Activity and Stress Management Session 4: CVD Risk factors: cholesterol, blood sugar, & Smoking Session 5: Health Communication, Healthcare access & Review
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Wait-list
Intervention Type
Behavioral
Intervention Name(s)
CHW Intervention
Intervention Description
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.).
Intervention Type
Behavioral
Intervention Name(s)
Wait List Control Group
Intervention Description
4 education sessions beginning 6-12 months later.
Primary Outcome Measure Information:
Title
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
Title
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
Title
Percent of patients with HbA1c <7 (for patients with hypertension + diabetes) at 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Percent of patients with diagnosis of hypertension with a BP measure taken in the past 6 months
Time Frame
6 months
Title
Percent of patients without hypertension having valid BP measurement, last 12 months
Time Frame
12 months
Title
Percent of current hypertensive patients screened for diabetes in last year
Time Frame
12 months
Title
Percent of current hypertensive patients receiving counseling on BMI, diet and physical activity
Time Frame
12 months
Title
Percent of current diagnosed hypertensive patients referred to a nutritionist in the past year
Time Frame
12 months
Title
Percent of current diagnosed hypertensive patients who smoke who have been referred for smoking cessation
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadia Islam
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29207983
Citation
Lopez PM, Zanowiak J, Goldfeld K, Wyka K, Masoud A, Beane S, Kumar R, Laughlin P, Trinh-Shevrin C, Thorpe L, Islam N. Protocol for project IMPACT (improving millions hearts for provider and community transformation): a quasi-experimental evaluation of an integrated electronic health record and community health worker intervention study to improve hypertension management among South Asian patients. BMC Health Serv Res. 2017 Dec 6;17(1):810. doi: 10.1186/s12913-017-2767-1.
Results Reference
derived

Learn more about this trial

Project IMPACT: CHW Intervention

We'll reach out to this number within 24 hrs