Cardiovascular Intervention Improvement Telemedicine Study
Behavioral: Pharmacist CVD
|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|
- CVD Risk profile [ Time Frame: Baseline, 6 & 12 months ] [ Designated as safety issue: No ]
- Survey measures on Physical Activity, Diet [ Time Frame: Baseline 6, & 12 months ] [ Designated as safety issue: No ]
- BMI calculated from vitals obtained during interview [ Time Frame: Baseline 6, & 12 months ] [ Designated as safety issue: No ]
- Systolic BP collected during bp outcome measurement conducted at interviews [ Time Frame: Baseline, 6 & 12 months ] [ Designated as safety issue: No ]
- LDL collected during interview visit to lab [ Time Frame: Baseline, 6 &12 months ] [ Designated as safety issue: No ]
- HBA1C in Diabetic patients collected at during interview visit to lab [ Time Frame: Baseline, 6 & 12 months ] [ Designated as safety issue: No ]
- Medication adherence - as determined by pill refill using a calculated Med-out index. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||November 2011|
|Study Completion Date:||May 2015|
|Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
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.
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:
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01142908
|United States, North Carolina|
|Durham VA Medical Center, Durham, NC|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Hayden B. Bosworth, PhD||Durham VA Medical Center, Durham, NC|