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).
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
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Hypertension
- 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.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension, Obesity
- 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.
- First posted26 May 2000 (estimated)
- Study startSep 1993
- Study completionAug 1997
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Adherence to Interventions for Hypertension
- ClinicalTrials.gov ID
- NCT00005708
- Acronym / sponsor ID
- 4917
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 1993
- Study completion
- Aug 1997 (actual)
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To develop effective strategies for enhancing adherence to therapeutic interventions designed to improve care for hypertensive minority populations.
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.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2016.
- Background: PubMed 10701818Ward 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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.