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

About this trial
This is an interventional supportive care trial for Hypertension
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.
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
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
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