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Cardiovascular DiseasesPhase 4NCT00123045

Patient-Physician Partnership to Improve High Blood Pressure Adherence

A Phase 4 study testing health education in people with Cardiovascular Diseases and Hypertension, 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 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiovascular Diseases, Hypertension
What is being tested?
health education
How many people
279 participants
Where
No sites listed yet
Study dates
Sep 2001to Aug 2005
Phase
Phase 4
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

About this study

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.

Read the detailed description

BACKGROUND:

Hypertension is a common, chronic condition that contributes substantially to cardiovascular morbidity and mortality and resource use. Despite the proven efficacy of pharmacologic therapy and lifestyle modification for treatment of hypertension and prevention of its complications, most adults with established hypertension are uncontrolled. Limited access to medical care and financial barriers to obtaining medications play an important role; however, even among patients who receive regular care, blood pressure control remains suboptimal. Patient non-adherence to recommended therapies and problems in physician management of patients with hypertension are critical contributors to poor quality of care and negative health outcomes of hypertension. Of particular concern is the disproportionately high prevalence and incidence of hypertension and its complications among African Americans and socioeconomically disadvantaged persons. Ethnic and social class disparities in patient adherence are frequently based on financial, logistical, environmental, and cultural barriers that, while not unique to ethnic minorities and the poor, have a greater impact on these populations. Patient and physician interventions were designed to address the specific needs of inner city ethnic minorities and persons living in poverty. The study used a patient-centered, culturally tailored, education and activation intervention with active follow-up delivered by a community health worker in the clinic. It also included a computerized, self-study communication skills training program delivered via an interactive CD-ROM, with tailored feedback to address physicians' individual communication skills needs.

DESIGN NARRATIVE:

The study used a patient-centered, culturally tailored, education and activation intervention with active follow-up delivered by a community health worker in the clinic. It also included a computerized, self-study communication skills training program delivered via an interactive CD-ROM, with tailored feedback to address physicians' individual communication skills needs. Fifty physicians and 500 of their patients who had uncontrolled hypertension were recruited into a randomized controlled trial with a 2X2 factorial design. The 50 physicians were randomized to receive either a 2-hour CD-ROM based communication skills training or no training. Within each randomized physician, 10 patient-subjects were randomized to either minimal intervention or patient activation (community health worker visit and follow-up calls, plus photo novels and other mailed educational literature). Assessments of primary care appointment keeping, medication possession, medication taking, health status, satisfaction, and numerous other variables were made at baseline, 3 months, and 12 months.

Being tested
health education
Medical subject headings
Cardiovascular Diseases, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • health educationBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient adherence

    self-report, Morisky measure

    Measured: 12 months

Secondary outcomes (1)
  1. Reduction in systolic blood pressure

    change in systolic blood pressure from baseline to 12 months of follow-up

    Measured: 12 months

Timeline

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

  1. First posted22 Jul 2005 (estimated)
  2. Study startSep 2001
  3. Primary completionAug 2005
  4. Study completionAug 2005

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
279 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00123045
Sponsor's protocol ID
232
Other IDs
R01HL069403
Status last verified
Jul 2011
First submitted
20 Jul 2005
Last updated
29 Jul 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing health education in people with Cardiovascular Diseases and Hypertension, 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 29 Jul 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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.

What does the primary outcome measure?

Patient adherence (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 29 Jul 2016.

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