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Cardiovascular DiseasesNCT00005708

Improving Adherence to Interventions for Hypertension

An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To develop effective strategies for enhancing adherence to therapeutic interventions designed to improve care for hypertensive minority populations. Read more about this study

Who is it for?
Ages Up to 100 years, men only
How many people
Not given
Where
No sites listed yet
Study dates
Sep 1993to Aug 1997
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 100 years
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

No eligibility criteria

About this study

To develop effective strategies for enhancing adherence to therapeutic interventions designed to improve care for hypertensive minority populations.

Read the detailed description

BACKGROUND:

The study was in response to a demonstration and education initiative, "Improving Hypertensive Care for Inner City Minorities", which was reviewed and approved by the Clinical Applications and Prevention Advisory Committee in April 1992 and by the National Heart, Lung, and Blood Advisory Council in May 1992. The Request for Applications was released in October 1992.

DESIGN NARRATIVE:

An aggressive Hypertension Intervention Project (HIP) was developed in the Hypertension Research Section of King/Drew Medical Center in South-Central Los Angeles. The private CHUER clinic (located in the same cachement area) subcontracted with the Drew University Center in a community coalition consisting of several large health advocacy organizations. All subjects were randomized into usual care (controls) or interventional care (experimental) at the initiation of the HIP. The cornerstone of the aggressive intervention was the development of a computerized patient tracking system and the introduction into the clinic of several educational activities including a) exit interviews; b) home visits; c) support group sessions, and d) community health seminars/fairs. Community Health Workers performed the bulk of the patient tracking and educational intervention field work. Outcome measures of pre and post-study blood pressure, renal function, body weight change, and all-cause mortality were compared between experimental and controls at two, three and four years into the study. Quality-of-life questionnaires were obtained pre- and post-study and analyzed for new insights into needs assessment, awareness of hypertension, attitudes towards treatment, compliance with drug therapy, and effectiveness of various educational interventions employed in the study. Concurrent efforts to reduce co-morbid risk factors such as obesity, cigarette smoking, excessive alcohol consumption and stress were assessed as secondary outcomes. The HIP hoped to demonstrate cost-effective innovations for the adaptation of these Medical Center-targeted strategies to community physicians and health clinics of the inner city.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Medical subject headings
Cardiovascular Diseases, Heart Diseases, Hypertension, Obesity

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2000 (estimated)
  2. Study startSep 1993
  3. Study completionAug 1997

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005708
Sponsor's protocol ID
4917
Other IDs
R01HL051119
Status last verified
Jul 2000
First submitted
25 May 2000
Last updated
18 Feb 2016
Results posted
No

Publications

  • Ward HJ, Morisky DE, Lees NB, Fong R. A clinic and community-based approach to hypertension control for an underserved minority population: design and methods. Am J Hypertens. 2000 Feb;13(2):177-83. doi: 10.1016/s0895-7061(99)00149-1.

    PubMed 10701818

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00005708, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2016.

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