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Cardiovascular Intervention Improvement Telemedicine Study

Cardiovascular Intervention Improvement Telemedicine Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01142908
Enrollment
428
Registered
2010-06-11
Start date
2011-11-01
Completion date
2015-05-22
Last updated
2023-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, Diabetes, Hyperlipidemia, Hypertension

Keywords

Cardiovascular Disease, Hypertension, Diabetes, Hyperlipidemia, Adherence

Brief summary

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.

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.

Interventions

BEHAVIORALPharmacist CVD

clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent)BaselineComponents 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.

Secondary

MeasureTime frameDescription
Mean Diastolic Blood PressureBaselineMean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews
Medication Non-adherenceBaselineFirst 4 items of the 5 item Morisky Self-reported measure of medication adherence was used to determine medication non-adherence.
Mean Systolic Blood PressureBaselineMean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews
Body Mass IndexBaselineCalculated from vitals (height & weight) obtained during interview
HBA1C in Diabetic PatientsBaselineLab values collected at interview visit by lab personnel
Cholesterol LDLBaselineCollected during interview visit by lab personnel

Countries

United States

Participant flow

Participants by arm

ArmCount
Pharmacist CVD
The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
215
Education Control
The education control group - these participants will receive educational material about CVD reduction.
213
Total428

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath14
Overall StudyExcluded - did not meet criteria95
Overall StudyLost to Follow-up1913
Overall StudyWithdrawal by Subject30

Baseline characteristics

CharacteristicPharmacist CVDEducation ControlTotal
Age, Continuous60.9 years
STANDARD_DEVIATION 8.4
61.5 years
STANDARD_DEVIATION 8.9
61.2 years
STANDARD_DEVIATION 8.7
Race/Ethnicity, Customized
Black
111 participants102 participants213 participants
Race/Ethnicity, Customized
Other
10 participants4 participants14 participants
Race/Ethnicity, Customized
Refused/Missing
1 participants1 participants2 participants
Race/Ethnicity, Customized
White
93 participants106 participants199 participants
Region of Enrollment
United States
215 participants213 participants428 participants
Sex: Female, Male
Female
33 Participants32 Participants65 Participants
Sex: Female, Male
Male
182 Participants181 Participants363 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 2150 / 213
serious
Total, serious adverse events
126 / 215123 / 213

Outcome results

Primary

Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent)

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.

Time frame: 12 months

Population: 43 out of the 215 participants in the Pharmacist CVD group and 33 of the 213 participants in the Education Control group had missing data at 12 months due to entirely missing the 12 month assessment or having missing data on one or more of the Framingham components.

ArmMeasureValue (MEAN)Dispersion
Pharmacist CVDFramingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent)28.9 % 10 yr RiskStandard Deviation 15.5
Education ControlFramingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent)28.4 % 10 yr RiskStandard Deviation 18.3
Comparison: Comparison at 12 monthsp-value: 0.7495% CI: [-2.4, 1.7]Mixed Models Analysis
Primary

Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent)

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.

Time frame: Baseline

Population: Two out of the 215 participants in the Pharmacist CVD group had missing data due to not having the blood pressure component of the Framingham collected at baseline.

ArmMeasureValue (MEAN)Dispersion
Pharmacist CVDFramingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent)32.4 % 10 yr RiskStandard Deviation 18.8
Education ControlFramingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent)31.6 % 10 yr RiskStandard Deviation 18.6
Primary

Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent)

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.

Time frame: 6 months

Population: 29 out of the 215 participants in the Pharmacist CVD group and 24 of the 213 participants in the Education Control group had missing data at 6 months due to entirely missing the 6 month assessment or having missing data on one or more of the Framingham components.

ArmMeasureValue (MEAN)Dispersion
Pharmacist CVDFramingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent)30.0 % 10 yr RiskStandard Deviation 17.2
Education ControlFramingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent)30.2 % 10 yr RiskStandard Deviation 18.7
Comparison: Comparison at 6 monthsp-value: 0.195% CI: [-3.9, 0.3]Mixed Models Analysis
Secondary

Body Mass Index

Calculated from vitals (height & weight) obtained during interview

Time frame: 12 months

Population: 39 out of the 215 participants in the Pharmacist CVD group and 31 out of the 213 in the Education Control group had missing body mass index at 12 months due to missing the 12 month interview entirely or the interview was completed over the phone, or weight was not obtained at the 12 month interview.

ArmMeasureValue (MEAN)Dispersion
Pharmacist CVDBody Mass Index31.9 kg/m^2Standard Deviation 6
Education ControlBody Mass Index31.6 kg/m^2Standard Deviation 5.7
Comparison: Comparison at 12 months.p-value: 0.5495% CI: [-0.4, 0.2]Mixed Models Analysis
Secondary

Body Mass Index

Calculated from vitals (height & weight) obtained during interview

Time frame: 6 months

Population: 30 out of the 215 participants in the Pharmacist CVD group and 23 out of the 213 in the Education Control group had missing body mass index at 6 months due to missing the 6 month interview entirely or the interview was completed over the phone, or weight was not obtained at the 6 month interview.

ArmMeasureValue (MEAN)Dispersion
Pharmacist CVDBody Mass Index32.1 kg/m^2Standard Deviation 6.3
Education ControlBody Mass Index31.5 kg/m^2Standard Deviation 5.4
Comparison: Comparison at 6 monthsp-value: 0.8395% CI: [-0.2, 0.2]Mixed Models Analysis
Secondary

Body Mass Index

Calculated from vitals (height & weight) obtained during interview

Time frame: Baseline

Population: 5 out of the 215 participants in the Pharmacist CVD group and 1 out of the 213 participants in the Education Control group had missing data due weight and/or height not collected at baseline.

ArmMeasureValue (MEAN)Dispersion
Pharmacist CVDBody Mass Index31.9 kg/m^2Standard Deviation 5.8
Education ControlBody Mass Index31.6 kg/m^2Standard Deviation 5.7
Secondary

Cholesterol LDL

Collected during interview visit by lab personnel

Time frame: 12 months

Population: 34 out of the 215 participants in the Pharmacist CVD group and 27 out of the 213 in the Education Control group had missing cholesterol LDL at 12 months due to missing the 12 month interview entirely or not completing the lab assessment.

ArmMeasureValue (MEAN)Dispersion
Pharmacist CVDCholesterol LDL114.4 mg/dLStandard Deviation 36.8
Education ControlCholesterol LDL115.3 mg/dLStandard Deviation 34
Comparison: Comparison at 12 months.p-value: 0.7995% CI: [-6.6, 5]Mixed Models Analysis
Secondary

Cholesterol LDL

Collected during interview visit by lab personnel

Time frame: 6 months

Population: 29 out of the 215 participants in the Pharmacist CVD group and 22 out of the 213 in the Education Control group had missing cholesterol LDL at 6 months due to missing the 6 month interview entirely or not completing the lab assessment.

ArmMeasureValue (MEAN)Dispersion
Pharmacist CVDCholesterol LDL114.9 mg/dLStandard Deviation 34.9
Education ControlCholesterol LDL118.9 mg/dLStandard Deviation 34.3
Comparison: Comparison at 6 monthsp-value: 0.0895% CI: [-10.3, 0.6]Mixed Models Analysis
Secondary

Cholesterol LDL

Collected during interview visit by lab personnel

Time frame: Baseline

Population: 4 out of the 215 participants in the Pharmacist CVD group and 2 out of the 213 participants in the Education Control group had missing data due to not having cholesterol LDL collected at baseline.

ArmMeasureValue (MEAN)Dispersion
Pharmacist CVDCholesterol LDL125.5 mg/dLStandard Deviation 37.3
Education ControlCholesterol LDL123.9 mg/dLStandard Deviation 36.2
Secondary

HBA1C in Diabetic Patients

Lab values collected at interview visit by lab personnel

Time frame: 12 months

Population: 14 out of the 85 participants in the Pharmacist CVD group with diabetes at baseline and 15 out of the 86 participants in the Education Control group with diabetes at baseline had missing HBA1C at 6 months due to missing the 6 month interview entirely or not completing the lab assessment.

ArmMeasureValue (MEAN)Dispersion
Pharmacist CVDHBA1C in Diabetic Patients7.5 percentage of glycosylated hemoglobinStandard Deviation 1.8
Education ControlHBA1C in Diabetic Patients7.7 percentage of glycosylated hemoglobinStandard Deviation 1.7
Comparison: Comparison at 12 monthsp-value: 0.7295% CI: [-0.5, 0.4]Mixed Models Analysis
Secondary

HBA1C in Diabetic Patients

Lab values collected at interview visit by lab personnel

Time frame: Baseline

Population: 4 out of the 85 participants in the Pharmacist CVD group with diabetes at baseline and 2 out of the 86 participants in the Education Control group with diabetes at baseline had missing data due to not having HBA1C collected at baseline.

ArmMeasureValue (MEAN)Dispersion
Pharmacist CVDHBA1C in Diabetic Patients8.0 percentage of glycosylated hemoglobinStandard Deviation 2.3
Education ControlHBA1C in Diabetic Patients7.6 percentage of glycosylated hemoglobinStandard Deviation 1.7
Secondary

HBA1C in Diabetic Patients

Lab values collected at interview visit by lab personnel

Time frame: 6 months

Population: 12 out of the 85 participants in the Pharmacist CVD group with diabetes at baseline and 11 out of the 86 participants in the Education Control group with diabetes at baseline had missing HBA1C at 6 months due to missing the 6 month interview entirely or not completing the lab assessment.

ArmMeasureValue (MEAN)Dispersion
Pharmacist CVDHBA1C in Diabetic Patients7.5 percentage of glycosylated hemoglobinStandard Deviation 1.8
Education ControlHBA1C in Diabetic Patients7.7 percentage of glycosylated hemoglobinStandard Deviation 1.8
Comparison: Comparison at 6 monthsp-value: 0.2995% CI: [-0.6, 0.2]Mixed Models Analysis
Secondary

Mean Diastolic Blood Pressure

Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews

Time frame: 12 months

Population: 36 out of the 215 participants in the Pharmacist CVD group and 30 out of the 213 in the Education Control group had missing blood pressure measurement at 12 months due to missing the 12 month interview entirely or blood pressure not collected at the 12 mo. assessment due to patient arm size exceeding cuff size or interview completed over the phone.

ArmMeasureValue (MEAN)Dispersion
Pharmacist CVDMean Diastolic Blood Pressure73.4 mmHgStandard Deviation 10.3
Education ControlMean Diastolic Blood Pressure73.1 mmHgStandard Deviation 10.9
Comparison: Comparison at 12 months.p-value: 0.795% CI: [-1.5, 2.2]Mixed Models Analysis
Secondary

Mean Diastolic Blood Pressure

Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews

Time frame: 6 months

Population: 28 out of the 215 participants in the Pharmacist CVD group and 23 out of the 213 in the Education Control group had missing blood pressure measurement at 6 months due to missing the 6 month interview entirely or blood pressure not collected at the 6 month assessment due to patient arm size exceeding cuff size or interview completed over the phone.

ArmMeasureValue (MEAN)Dispersion
Pharmacist CVDMean Diastolic Blood Pressure74.0 mmHgStandard Deviation 11
Education ControlMean Diastolic Blood Pressure74.1 mmHgStandard Deviation 11.9
Comparison: Comparison at 6 monthsp-value: 0.9195% CI: [-2, 1.8]Mixed Models Analysis
Secondary

Mean Diastolic Blood Pressure

Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews

Time frame: Baseline

Population: One out of the 215 participants in the Pharmacist CVD group did not have blood pressure collected at baseline.

ArmMeasureValue (MEAN)Dispersion
Pharmacist CVDMean Diastolic Blood Pressure75.8 mmHgStandard Deviation 11.5
Education ControlMean Diastolic Blood Pressure75.8 mmHgStandard Deviation 12.4
Secondary

Mean Systolic Blood Pressure

Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews

Time frame: Baseline

Population: One out of the 215 participants in the Pharmacist CVD group did not have blood pressure collected at baseline.

ArmMeasureValue (MEAN)Dispersion
Pharmacist CVDMean Systolic Blood Pressure130.6 mmHgStandard Deviation 18.5
Education ControlMean Systolic Blood Pressure129.7 mmHgStandard Deviation 18.8
Secondary

Mean Systolic Blood Pressure

Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews

Time frame: 12 months

Population: 36 out of the 215 participants in the Pharmacist CVD group and 30 out of the 213 in the Education Control group had missing blood pressure measurement at 12 mo. due to missing the 12 month interview entirely or blood pressure not collected at the 12 month assessment due to patient arm size exceeding cuff size or interview completed over the phone.

ArmMeasureValue (MEAN)Dispersion
Pharmacist CVDMean Systolic Blood Pressure128.5 mmHgStandard Deviation 15.4
Education ControlMean Systolic Blood Pressure126.4 mmHgStandard Deviation 16.2
Comparison: Comparison at 12 months.p-value: 0.3495% CI: [-1.5, 4.3]Mixed Models Analysis
Secondary

Mean Systolic Blood Pressure

Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews

Time frame: 6 months

Population: 28 out of the 215 participants in the Pharmacist CVD group and 23 out of the 213 in the Education Control group had missing blood pressure measurement at 6 months due to missing the 6 month interview entirely or blood pressure not collected at the 6 month assessment due to patient arm size exceeding cuff size or interview completed over the phone.

ArmMeasureValue (MEAN)Dispersion
Pharmacist CVDMean Systolic Blood Pressure128.3 mmHgStandard Deviation 16.5
Education ControlMean Systolic Blood Pressure127.7 mmHgStandard Deviation 16.8
Comparison: Comparison at 6 monthsp-value: 0.9395% CI: [-2.8, 3.1]Mixed Models Analysis
Secondary

Medication Non-adherence

First 4 items of the 5 item Morisky Self-reported measure of medication adherence was used to determine medication non-adherence.

Time frame: 6 months

Population: 28 out of the 215 participants in the Pharmacist CVD group and 18 out of the 213 participants in the Education Control group had missing data for medication non-adherence due to missing the 6 month assessment or non-response of adherence items collected in the 6 month interview.

ArmMeasureValue (NUMBER)
Pharmacist CVDMedication Non-adherence92 participants
Education ControlMedication Non-adherence85 participants
Comparison: Comparison at 6 monthsp-value: 0.8795% CI: [-0.4, 0.3]Gen. Est. Equation with a Logit Link
Secondary

Medication Non-adherence

First 4 items of the 5 item Morisky Self-reported measure of medication adherence was used to determine medication non-adherence.

Time frame: Baseline

Population: 5 out of the 215 participants in the Pharmacist CVD group and 2 out of the 213 participants in the Education Control group had missing data for medication non-adherence due to non-response of adherence items collected in the baseline interview.

ArmMeasureValue (NUMBER)
Pharmacist CVDMedication Non-adherence137 participants
Education ControlMedication Non-adherence110 participants
Secondary

Medication Non-adherence

First 4 items of the 5 item Morisky Self-reported measure of medication adherence was used to determine medication non-adherence.

Time frame: 12 months

Population: 35 out of the 215 participants in the Pharmacist CVD group and 24 out of the 213 participants in the Education Control group had missing data for medication non-adherence due to missing the 12 month assessment or non-response of adherence items collected in the 12 month interview.

ArmMeasureValue (NUMBER)
Pharmacist CVDMedication Non-adherence96 participants
Education ControlMedication Non-adherence82 participants
Comparison: Comparison at 12 months.p-value: 0.3695% CI: [-0.2, 0.5]Gen. Est. Equation with a Logit Link

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026