Understanding Health Care Information for African America... | NCT01389037

Studies
Understanding Health Care Information for African Americans With High Blood Pressure

NCT01389037

Sponsor

Johns Hopkins University

Status

Completed

Last Update Posted

Dec 11, 2017Actual

Enrollment

198Actual

Phase

Not Applicable

Conditions

Hypertension

Interventions

Health Literacy-focused Self-help
Delayed Intervention Control

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1P30NR011409	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2011Actual

Primary Completion Date

Jun 2014Actual

Completion Date

Jun 2014Actual

First Submitted Date

Jul 5, 2011

First Submission Date that Met QC Criteria

Jul 6, 2011

First Posted Date

Jul 7, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 7, 2017

Last Update Posted Date

Dec 11, 2017Actual

Name	Class
National Institute of Nursing Research (NINR)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This clinical trial focuses on helping African Americans with high blood pressure to manage their disease. The study will target their ability to read and understand health information (also called health literacy). The research method relies on community participation in equal partnership with the researchers to provide interactive workshops and home blood pressure self-monitoring with the assistance of telephone counseling by community health workers.

Detailed Description

The purpose of this study is to develop a culturally sensitive intervention focused on health literacy that is designed to reduce high blood pressure (HBP) in a vulnerable African American (AA) population. A community-based participatory research approach delivered by community health workers (CHW) will be used to address the following specific aims: Aim 1. To examine the effect of health literacy on self-care skills, including HBP knowledge, adherence to HBP and substance abuse treatment recommendations, communication skills, health care utilization, and BP outcomes in AAs with HBP. Aim 2. To conduct a pilot randomized, controlled trial with a delayed intervention control group to test the effectiveness of a health literacy-focused self-help HBP intervention program using CHWs in 100 AAs who reside in Baltimore City.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

198Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Health Literacy-focused Self-help	Experimental		Behavioral: Health Literacy-focused Self-help
Delayed intervention control	Placebo Comparator		Behavioral: Delayed Intervention Control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Health Literacy-focused Self-help	Behavioral	Weekly 2-hour sessions over 6 weeks followed by 12 month follow-up with home blood pressure self monitoring with telephone counseling by community health workers.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Decreased blood pressure		12 months

Secondary Outcomes

Measure	Description	Time Frame
Increase adherence to recommended blood pressure management		12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Self-identified as African American aged 18 years or older;
Systolic BP >140 and/or Diastolic BP >90 mmHg or SBP >135 and/or DBP >85 mmHg for individuals with diabetes mellitus or chronic kidney disease or on HBP medication; and
Has a land-based telephone in the home or a cellular phone.

Exclusion Criteria:

Participation in another ongoing trial;
Acute and/or terminal condition precluding participation, such as terminal cancer;
Hospitalization for stroke, myocardial infarction, coronary artery vascularization in the past 3 months;
Recipient of an organ transplant or on kidney dialysis; and
Psychiatric diagnosis precluding participation, such as schizophrenia or cognitive impairment as measured by Mini-Mental State Exam (score < 24)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Benita Walton-Moss, DNS	Johns Hopkins University School of Nursing	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Johns Hopkins University		Baltimore	Maryland	21205	United States

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided