Cardiovascular Intervention Improvement Telemedicine Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01142908
First received: May 24, 2010
Last updated: April 7, 2016
Last verified: April 2016
  Purpose
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.

Condition Intervention
Cardiovascular Disease
Hypertension
Diabetes
Hyperlipidemia
Behavioral: Pharmacist CVD

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cardiovascular Intervention Improvement Telemedicine Study

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Mean Systolic Blood Pressure [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews

  • Mean Systolic Blood Pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews

  • Mean Systolic Blood Pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews

  • Mean Diastolic Blood Pressure [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews

  • Mean Diastolic Blood Pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews

  • Mean Diastolic Blood Pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews

  • Medication Non-adherence [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    First 4 items of the 5 item Morisky Self-reported measure of medication adherence was used to determine medication non-adherence.

  • Medication Non-adherence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    First 4 items of the 5 item Morisky Self-reported measure of medication adherence was used to determine medication non-adherence.

  • Medication Non-adherence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    First 4 items of the 5 item Morisky Self-reported measure of medication adherence was used to determine medication non-adherence.

  • Cholesterol LDL [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Collected during interview visit by lab personnel

  • Cholesterol LDL [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Collected during interview visit by lab personnel

  • Cholesterol LDL [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Collected during interview visit by lab personnel

  • Body Mass Index [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Calculated from vitals (height & weight) obtained during interview

  • Body Mass Index [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Calculated from vitals (height & weight) obtained during interview

  • Body Mass Index [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Calculated from vitals (height & weight) obtained during interview

  • HBA1C in Diabetic Patients [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Lab values collected at interview visit by lab personnel

  • HBA1C in Diabetic Patients [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Lab values collected at interview visit by lab personnel

  • HBA1C in Diabetic Patients [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Lab values collected at interview visit by lab personnel


Enrollment: 428
Study Start Date: November 2011
Study Completion Date: May 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01142908

Locations
United States, North Carolina
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Hayden B. Bosworth, PhD Durham VA Medical Center, Durham, NC
  More Information

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01142908     History of Changes
Other Study ID Numbers: IIR 08-297 
Study First Received: May 24, 2010
Results First Received: March 1, 2016
Last Updated: April 7, 2016
Health Authority: United States: Federal Government

Keywords provided by VA Office of Research and Development:
Cardiovascular Disease
Hypertension
Diabetes
Hyperlipidemia
Adherence

Additional relevant MeSH terms:
Cardiovascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 22, 2016