Cardiovascular Intervention Improvement Telemedicine Study

July 19, 2023 updated by: VA Office of Research and Development
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

428

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705-3875
        • Durham VA Medical Center, Durham, NC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Enrolled in one of three Durham Veterans Affairs Medical Center (DVAMC) Primary Care Clinics affiliated with the hospital or the Raleigh Community-Based Outpatient Clinic (CBOC) for at least one year;
  • At least one visit to a primary care physician (PCP) at the Raleigh CBOC or Durham Veterans Affairs Medical Center (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
  • HbA1C value in the last 90day > 10% and patient is currently not on an insulin regimen.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
Behavioral: Pharmacist CVD
clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
No Intervention: Arm 2
The education control group - these participants will receive educational material about CVD reduction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent)
Time Frame: Baseline
Components of the Framingham include gender, age fixed at baseline, systolic blood pressure (presence/absence of blood pressure medications at each time point [combination of administrative med data pull and self-report at assessment]), total cholesterol, HDL cholesterol, smoking status (assessed via self-report at each study survey), and diabetes (diabetes is a combination of self-report and VA Computerized Patient Record System (CPRS) data review). "New cases" of diabetes are allowed to be updated at 6 and 12 months f/u.
Baseline
Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent)
Time Frame: 6 months
Components of the Framingham include gender, age fixed at baseline, systolic blood pressure (presence/absence of blood pressure medications at each time point [combination of administrative med data pull and self-report at assessment]), total cholesterol, HDL cholesterol, smoking status (assessed via self-report at each study survey), and diabetes (diabetes is a combination of self-report and CPRS data review). "New cases" of diabetes are allowed to be updated at 6 and 12 months f/u.
6 months
Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent)
Time Frame: 12 months
Components of the Framingham include gender, age fixed at baseline, systolic blood pressure (presence/absence of blood pressure medications at each time point [combination of administrative med data pull and self-report at assessment]), total cholesterol, HDL cholesterol, smoking status (assessed via self-report at each study survey), and diabetes (diabetes is a combination of self-report and CPRS data review). "New cases" of diabetes are allowed to be updated at 6 and 12 months f/u.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Systolic Blood Pressure
Time Frame: Baseline
Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews
Baseline
Mean Systolic Blood Pressure
Time Frame: 6 months
Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews
6 months
Mean Systolic Blood Pressure
Time Frame: 12 months
Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews
12 months
Mean Diastolic Blood Pressure
Time Frame: Baseline
Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews
Baseline
Mean Diastolic Blood Pressure
Time Frame: 6 months
Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews
6 months
Mean Diastolic Blood Pressure
Time Frame: 12 months
Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews
12 months
Medication Non-adherence
Time Frame: Baseline
First 4 items of the 5 item Morisky Self-reported measure of medication adherence was used to determine medication non-adherence.
Baseline
Medication Non-adherence
Time Frame: 6 months
First 4 items of the 5 item Morisky Self-reported measure of medication adherence was used to determine medication non-adherence.
6 months
Medication Non-adherence
Time Frame: 12 months
First 4 items of the 5 item Morisky Self-reported measure of medication adherence was used to determine medication non-adherence.
12 months
Cholesterol LDL
Time Frame: Baseline
Collected during interview visit by lab personnel
Baseline
Cholesterol LDL
Time Frame: 6 months
Collected during interview visit by lab personnel
6 months
Cholesterol LDL
Time Frame: 12 months
Collected during interview visit by lab personnel
12 months
Body Mass Index
Time Frame: Baseline
Calculated from vitals (height & weight) obtained during interview
Baseline
Body Mass Index
Time Frame: 6 months
Calculated from vitals (height & weight) obtained during interview
6 months
Body Mass Index
Time Frame: 12 months
Calculated from vitals (height & weight) obtained during interview
12 months
HBA1C in Diabetic Patients
Time Frame: Baseline
Lab values collected at interview visit by lab personnel
Baseline
HBA1C in Diabetic Patients
Time Frame: 6 months
Lab values collected at interview visit by lab personnel
6 months
HBA1C in Diabetic Patients
Time Frame: 12 months
Lab values collected at interview visit by lab personnel
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Hayden B Bosworth, PhD, Durham VA Medical Center, Durham, NC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2011

Primary Completion (Actual)

April 30, 2015

Study Completion (Actual)

May 22, 2015

Study Registration Dates

First Submitted

May 24, 2010

First Submitted That Met QC Criteria

June 10, 2010

First Posted (Estimated)

June 11, 2010

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIR 08-297
  • 08-297 (Other Grant/Funding Number: VA HSRD)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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