NCT01389037

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Oct 2011

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 7, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

December 11, 2017

Status Verified

December 1, 2017

Enrollment Period

2.7 years

First QC Date

July 5, 2011

Last Update Submit

December 7, 2017

Conditions

Keywords

African AmericanHigh blood pressure

Outcome Measures

Primary Outcomes (1)

  • Decreased blood pressure

    12 months

Secondary Outcomes (1)

  • Increase adherence to recommended blood pressure management

    12 months

Study Arms (2)

Health Literacy-focused Self-help

EXPERIMENTAL
Behavioral: Health Literacy-focused Self-help

Delayed intervention control

PLACEBO COMPARATOR
Behavioral: Delayed Intervention Control

Interventions

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.

Health Literacy-focused Self-help

Given pamphlets on the importance of high blood pressure control and offered weekly workshops. This group will be offered the intervention at the conclusion of data collection.

Delayed intervention control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Benita Walton-Moss, DNS

    Johns Hopkins University School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2011

First Posted

July 7, 2011

Study Start

October 1, 2011

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

December 11, 2017

Record last verified: 2017-12

Locations