NCT00123045

Brief Summary

To test the efficacy of a patient-centered, culturally tailored education and activation intervention designed to improve adherence to medication and life style recommendations among adults with uncontrolled hypertension.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
279

participants targeted

Target at P50-P75 for phase_4 cardiovascular-diseases

Timeline
Completed

Started Sep 2001

Typical duration for phase_4 cardiovascular-diseases

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

Study Start

First participant enrolled

September 1, 2001

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

July 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2005

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
Last Updated

July 29, 2016

Status Verified

July 1, 2011

Enrollment Period

3.9 years

First QC Date

July 20, 2005

Last Update Submit

July 28, 2016

Conditions

Cardiovascular DiseasesHypertension

Outcome Measures

Primary Outcomes (1)

  • Patient adherence

    self-report, Morisky measure

    12 months

Secondary Outcomes (1)

  • Reduction in systolic blood pressure

    12 months

Interventions

health educationBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Physicians - general internists and family physicians who see patients at least 20 hours per week at one of the participating study sites. Physicians are excluded if they intend to leave the practice within 12 months. Patients - adults aged 18 years and older, with a diagnosis of hypertension (at least one claim with the ICD-9 code 401 in the preceding year), and able to provide contact information for themselves and at least one other person. Patients who are too acutely ill, disoriented, or unresponsive to complete the baseline assessment and those with medical conditions that might limit their participation in the study (e.g., AIDS/HIV, schizophrenia, cancer (except skin), Alzheimer's or other form of dementia; end-stage renal disease, congestive heart failure, or active tuberculosis) are excluded.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Cardiovascular DiseasesHypertension

Condition Hierarchy (Ancestors)

Vascular Diseases

Study Officials

  • Lisa A Cooper, MD, MPH

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
NIH

Study Record Dates

First Submitted

July 20, 2005

First Posted

July 22, 2005

Study Start

September 1, 2001

Primary Completion

August 1, 2005

Study Completion

August 1, 2005

Last Updated

July 29, 2016

Record last verified: 2011-07