View Clinical Trial (Medical Research Study)
Cardiovascular Intervention Improvement Telemedicine Study
| City: |
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Durham |
| State: |
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North Carolina |
| Zip Code: |
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27705 |
| Conditions: |
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Cardiovascular Disease - Hypertension - Diabetes - Hyperlipidemia |
| Purpose: |
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Cardiovascular disease (CVD) is the leading cause of death in the United States; more than
80% of veterans have > 2 risk factors for CVD. Our study is one of the first to examine the
implementation of a tailored behavioral/educational self-management intervention in primary
care clinics designed to improve CVD risk. The proposed study could result in a leap
forward in CVD risk management among veterans for several reasons: 1) ) This is a novel
extension of our previous interventions that have demonstrated improved BP, now designed to
address multiple chronic conditions contributing to CVD risk, particularly hyperlipidemia
and diabetes. The study focuses on both multiple CVD-related risk factor management and
medication management 2) The intervention is multi-behavioral; it addresses patients'
various health behavior (e.g., smoking, diet, and medication adherence). 3) Components of
the intervention will include specific recommendations and transportability of intervention
application software and tracking packages that will allow clinic managers to implement the
intervention if it is effective.
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| Study Summary: |
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Anticipated Impacts on Veteran's Healthcare: Cardiovascular disease (CVD) is the leading
cause of death in the U.S.; more than 80% of veterans have > 2 risk factors for CVD. An
intervention that addresses multiple CVD risk factors among high-risk veterans has the
greatest potential to improve morbidity and mortality.
Project Background/Rationale: The proposed study will take place in two VA primary care
clinics (1-Community-Based Outpatient Clinics and 1-primary care clinic affiliated with a
hospital). We will improve CVD risk among veterans by addressing the modifiable risk factors
of systolic blood pressure (SBP), smoking, and low-density lipoprotein cholesterol (LDL-C).
The intervention will be tailored to the needs of vulnerable high risk patients (e.g.
African Americans, low literate) and integrated into clinics, thereby enhancing the
potential for benefit and generalizability to other settings.
The proposed study could significantly improve CVD risk management among veterans for
several reasons: 1) This intervention is a novel extension of our previous efficacious
interventions, but provides a novel extension to address multiple chronic conditions
contributing to CVD risk. 2) The intervention focuses on both multiple CVD-related behaviors
and medication management. 3) The intervention was developed to ensure implementation across
a large and representative sample of veterans; and; 4) The intervention, if found
efficacious and financially self-sustaining, could be widely implemented within the VA
healthcare system.
Project Objectives: The proposed study will examine two research questions:
1. Can patients randomized to a clinical pharmacist-administered telephone behavioral/
medication management intervention tailored to their needs improve CVD outcomes
relative to a control group over 12 months? Primary Hypothesis: (H1) Veterans who
receive the behavioral/medication intervention will have greater improvement of their
CVD Risk Profile over the 12 months of follow-up as compared to the control group.
Secondary Hypotheses: (H2) Veterans who receive the intervention will have improved
medication adherence, physical activity, improved diet, lower body mass index as
compared to the control group over 12 months of follow-up. (H3) Veterans who receive
the intervention will have greater improvements in LDL over the 12 months of follow-up
as compared to the control group. (H4) Veterans with diabetes who receive the
intervention will have greater improved HbA1c as compared to the control group over 12
months of follow-up.
2. If the intervention is found to be effective, is it cost effective? Project Methods: To
address these hypotheses, we propose a two-arm randomized clinical trial design in
which 500 patients with cardiovascular disease will be randomized to either the
education control group or the intervention group. Patients randomized to the
intervention group will receive a clinical pharmacist-administered intervention, which
focuses on behavioral and a medication management. The intervention will occur over 12
months. Patients randomized to the control group will receive educational material
about CVD reduction. Given the national prevalence of CVD and the dismal rates of risk
factor control, intensive, but easily disseminated interventions such as the one
proposed could significantly improve treatment of this epidemic in the VA.
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| Criteria: |
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Inclusion Criteria:
- Enrolled in one of three DVAMC Primary Care Clinics affiliated with the hospital or
the Raleigh CBOC for at least one year;
- At least one visit to a PCP at the Raleigh CBOC or Durham VAMC associated primary
care clinics in the previous 12 months;
- Outpatient diagnostic code for hypertension and/or hypercholesterolemia and lab
values indicating either poorly controlled BP levels (>150/90 Hg) AND/OR LDL
(>130mg/dl) in the previous year.
Exclusion Criteria:
- diagnosed with metastatic cancer,
- diagnosed with dementia,
- active diagnosis of psychosis,
- treated with dialysis,
- most recent creatinine lab level >2.5 or no creatinine lab value within past year
- hospitalized for a stroke, heart attack, or had surgery for blocked arteries in the
past 3 months,
- participating in another interventional trial,
- not currently receiving care at the Durham VAMC or the Raleigh CBOC
- resident of a nursing home,
- hard time seeing type/printing on books, magazines articles, etc.
- hard time hearing on the telephone
- limited/no access to telephone
- plans to move medical care from DVAMC or Raleigh CBOC in next 12 months
- CVD care is currently being managed by a clinical pharmacist
- A1C value in the last 90day > 10% and patient is currently not on an insulin regimen.
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| NCT ID: |
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NCT01142908 |
| Primary Contact: |
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Principal Investigator
Hayden B. Bosworth, PhD
Department of Veterans Affairs
Hayden B Bosworth, PhD
Phone: (919) 296-6936
Email: hayden.bosworth@va.gov
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| Backup Contact: |
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Email: felicia.mccant@va.gov
Felicia A McCant
Phone: (919) 286-6936
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| Location Contact: |
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Durham, North Carolina 27705
United States
Dana C Tucker
Phone: 919-286-0411
Email: dana.tucker@va.gov
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
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