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CompletedNCT01142908Updated Jul 27, 2023Results posted

Cardiovascular Intervention Improvement Telemedicine Study

An interventional study of Pharmacist CVD in Cardiovascular Disease, Hypertension and Diabetes, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2023-07-27.

Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
428
Allocation
Randomized
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Cardiovascular Disease
  • Hypertension
  • Diabetes
  • Hyperlipidemia

Keywords

  • Cardiovascular Disease
  • Hypertension
  • Diabetes
  • Hyperlipidemia
  • Adherence
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 428 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.

Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
428 participants (actual)

Study arms

  • 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

  • No intervention
    Arm 2

    The education control group - these participants will receive educational material about CVD reduction.

Interventions

  • BehavioralPharmacist CVD

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

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. Cholesterol LDL

    Collected during interview visit by lab personnel

    Time frame: Baseline

  11. Cholesterol LDL

    Collected during interview visit by lab personnel

    Time frame: 6 months

  12. Cholesterol LDL

    Collected during interview visit by lab personnel

    Time frame: 12 months

  13. Body Mass Index

    Calculated from vitals (height \& weight) obtained during interview

    Time frame: Baseline

  14. Body Mass Index

    Calculated from vitals (height \& weight) obtained during interview

    Time frame: 6 months

  15. Body Mass Index

    Calculated from vitals (height \& weight) obtained during interview

    Time frame: 12 months

  16. HBA1C in Diabetic Patients

    Lab values collected at interview visit by lab personnel

    Time frame: Baseline

  17. HBA1C in Diabetic Patients

    Lab values collected at interview visit by lab personnel

    Time frame: 6 months

  18. HBA1C in Diabetic Patients

    Lab values collected at interview visit by lab personnel

    Time frame: 12 months

07

Results

Posted May 9, 2016

Participant flow

Participant flow — Overall Study
MilestonePharmacist CVDEducation Control
Started215213
6 month f/u188196
Completed183191
Not completed3222
Withdrew: Lost to follow-up1913
Withdrew: Death14
Withdrew: Excluded - did not meet criteria95
Withdrew: Withdrawal by subject30

Outcome measures

PrimaryFramingham 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
Reported as:
Mean · % 10 yr Risk
Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent)
% 10 yr RiskPharmacist CVDEducation Control
Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent)32.4 ± 18.831.6 ± 18.6
SecondaryMean 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
Reported as:
Mean · mmHg
Mean Systolic Blood Pressure
mmHgPharmacist CVDEducation Control
Mean Systolic Blood Pressure130.6 ± 18.5129.7 ± 18.8
SecondaryMean 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
Reported as:
Mean · mmHg
Mean Systolic Blood Pressure
mmHgPharmacist CVDEducation Control
Mean Systolic Blood Pressure128.3 ± 16.5127.7 ± 16.8
Statistical analysis
  • Pharmacist CVD vs Education Control · Mixed Models Analysis · p = 0.93 · Mean difference (net): 0.1 · 95% CI -2.8 to 3.1Direction of the test of comparison is Pharmacist Intervention minus Control
SecondaryMean 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
Reported as:
Mean · mmHg
Mean Systolic Blood Pressure
mmHgPharmacist CVDEducation Control
Mean Systolic Blood Pressure128.5 ± 15.4126.4 ± 16.2
Statistical analysis
  • Pharmacist CVD vs Education Control · Mixed Models Analysis · p = 0.34 · Mean difference (net): 1.4 · 95% CI -1.5 to 4.3Direction of the test of comparison is Pharmacist Intervention minus Control
SecondaryMean 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
Reported as:
Mean · mmHg
Mean Diastolic Blood Pressure
mmHgPharmacist CVDEducation Control
Mean Diastolic Blood Pressure75.8 ± 11.575.8 ± 12.4
SecondaryMean 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
Reported as:
Mean · mmHg
Mean Diastolic Blood Pressure
mmHgPharmacist CVDEducation Control
Mean Diastolic Blood Pressure74.0 ± 11.074.1 ± 11.9
Statistical analysis
  • Pharmacist CVD vs Education Control · Mixed Models Analysis · p = 0.91 · Mean difference (net): -0.1 · 95% CI -2.0 to 1.8Direction of the test of comparison is Pharmacist Intervention minus Control
SecondaryMean 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
Reported as:
Mean · mmHg
Mean Diastolic Blood Pressure
mmHgPharmacist CVDEducation Control
Mean Diastolic Blood Pressure73.4 ± 10.373.1 ± 10.9
Statistical analysis
  • Pharmacist CVD vs Education Control · Mixed Models Analysis · p = 0.70 · Mean difference (net): 0.4 · 95% CI -1.5 to 2.2Direction of the test of comparison is Pharmacist Intervention minus Control
PrimaryFramingham 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
Reported as:
Mean · % 10 yr Risk
Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent)
% 10 yr RiskPharmacist CVDEducation Control
Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent)30.0 ± 17.230.2 ± 18.7
Statistical analysis
  • Pharmacist CVD vs Education Control · Mixed Models Analysis · p = 0.1 · Mean difference (net): -1.8 · 95% CI -3.9 to 0.3Direction of the test of comparison is Pharmacist Intervention minus Control
PrimaryFramingham 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
Reported as:
Mean · % 10 yr Risk
Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent)
% 10 yr RiskPharmacist CVDEducation Control
Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent)28.9 ± 15.528.4 ± 18.3
Statistical analysis
  • Pharmacist CVD vs Education Control · Mixed Models Analysis · p = 0.74 · Mean difference (net): -0.3 · 95% CI -2.4 to 1.7Direction of the test of comparison is Pharmacist Intervention minus Control
SecondaryMedication 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
Reported as:
Number · participants
Medication Non-adherence
participantsPharmacist CVDEducation Control
Medication Non-adherence137110
SecondaryMedication 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
Reported as:
Number · participants
Medication Non-adherence
participantsPharmacist CVDEducation Control
Medication Non-adherence9285
Statistical analysis
  • Pharmacist CVD vs Education Control · Gen. Est. Equation with a Logit Link · p = 0.87 · Logit-difference (net): -0.03 · 95% CI -0.4 to 0.3Direction of the test of comparison is Pharmacist Intervention minus Control
SecondaryMedication 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
Reported as:
Number · participants
Medication Non-adherence
participantsPharmacist CVDEducation Control
Medication Non-adherence9682
Statistical analysis
  • Pharmacist CVD vs Education Control · Gen. Est. Equation with a Logit Link · p = 0.36 · Logit-difference (net): 0.2 · 95% CI -0.2 to 0.5Direction of the test of comparison is Pharmacist Intervention minus Control
SecondaryCholesterol LDL

Collected during interview visit by lab personnel

Time frame:
Baseline
Reported as:
Mean · mg/dL
Cholesterol LDL
mg/dLPharmacist CVDEducation Control
Cholesterol LDL125.5 ± 37.3123.9 ± 36.2
SecondaryCholesterol LDL

Collected during interview visit by lab personnel

Time frame:
6 months
Reported as:
Mean · mg/dL
Cholesterol LDL
mg/dLPharmacist CVDEducation Control
Cholesterol LDL114.9 ± 34.9118.9 ± 34.3
Statistical analysis
  • Pharmacist CVD vs Education Control · Mixed Models Analysis · p = 0.08 · Mean difference (net): -4.9 · 95% CI -10.3 to 0.6Direction of the test of comparison is Pharmacist Intervention minus Control
SecondaryCholesterol LDL

Collected during interview visit by lab personnel

Time frame:
12 months
Reported as:
Mean · mg/dL
Cholesterol LDL
mg/dLPharmacist CVDEducation Control
Cholesterol LDL114.4 ± 36.8115.3 ± 34.0
Statistical analysis
  • Pharmacist CVD vs Education Control · Mixed Models Analysis · p = 0.79 · Mean difference (net): -0.8 · 95% CI -6.6 to 5.0Direction of the test of comparison is Pharmacist Intervention minus Control
SecondaryBody Mass Index

Calculated from vitals (height \& weight) obtained during interview

Time frame:
Baseline
Reported as:
Mean · kg/m^2
Body Mass Index
kg/m^2Pharmacist CVDEducation Control
Body Mass Index31.9 ± 5.831.6 ± 5.7
SecondaryBody Mass Index

Calculated from vitals (height \& weight) obtained during interview

Time frame:
6 months
Reported as:
Mean · kg/m^2
Body Mass Index
kg/m^2Pharmacist CVDEducation Control
Body Mass Index32.1 ± 6.331.5 ± 5.4
Statistical analysis
  • Pharmacist CVD vs Education Control · Mixed Models Analysis · p = 0.83 · Mean difference (net): -0.02 · 95% CI -0.2 to 0.2Direction of the test of comparison is Pharmacist Intervention minus Control
SecondaryBody Mass Index

Calculated from vitals (height \& weight) obtained during interview

Time frame:
12 months
Reported as:
Mean · kg/m^2
Body Mass Index
kg/m^2Pharmacist CVDEducation Control
Body Mass Index31.9 ± 6.031.6 ± 5.7
Statistical analysis
  • Pharmacist CVD vs Education Control · Mixed Models Analysis · p = 0.54 · Mean difference (net): -0.1 · 95% CI -0.4 to 0.2Direction of the test of comparison is Pharmacist Intervention minus Control
SecondaryHBA1C in Diabetic Patients

Lab values collected at interview visit by lab personnel

Time frame:
Baseline
Reported as:
Mean · percentage of glycosylated hemoglobin
HBA1C in Diabetic Patients
percentage of glycosylated hemoglobinPharmacist CVDEducation Control
HBA1C in Diabetic Patients8.0 ± 2.37.6 ± 1.7
SecondaryHBA1C in Diabetic Patients

Lab values collected at interview visit by lab personnel

Time frame:
6 months
Reported as:
Mean · percentage of glycosylated hemoglobin
HBA1C in Diabetic Patients
percentage of glycosylated hemoglobinPharmacist CVDEducation Control
HBA1C in Diabetic Patients7.5 ± 1.87.7 ± 1.8
Statistical analysis
  • Pharmacist CVD vs Education Control · Mixed Models Analysis · p = 0.29 · Mean difference (net): -0.2 · 95% CI -0.6 to 0.2Direction of the test of comparison is Pharmacist Intervention minus Control
SecondaryHBA1C in Diabetic Patients

Lab values collected at interview visit by lab personnel

Time frame:
12 months
Reported as:
Mean · percentage of glycosylated hemoglobin
HBA1C in Diabetic Patients
percentage of glycosylated hemoglobinPharmacist CVDEducation Control
HBA1C in Diabetic Patients7.5 ± 1.87.7 ± 1.7
Statistical analysis
  • Pharmacist CVD vs Education Control · Mixed Models Analysis · p = 0.72 · Mean difference (net): -0.1 · 95% CI -0.5 to 0.4Direction of the test of comparison is Pharmacist Intervention minus Control

Adverse events

Collected over Adverse events were collected through out the study from baseline thru completion.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Pharmacist CVD—126/215 (58.6%)0/215 (0%)
Education Control—123/213 (57.7%)0/213 (0%)
Most frequent serious events
Showing 10 of 82
Most frequent serious events
EventPharmacist CVDEducation Control
Emergency room visitMusculoskeletal and connective tissue disorders27/21530/213
Emergency room visitInfections and infestations22/2155/213
Emergency room visitGeneral disorders14/21521/213
Emergency room visitCardiac disorders21/21515/213
Emergency room visitGastrointestinal disorders18/21513/213
Planned SurgerySurgical and medical procedures18/2159/213
Emergency room visitRespiratory, thoracic and mediastinal disorders16/21512/213
Study Safety ProtocolCardiac disorders10/21513/213
Emergency room visitEndocrine disorders4/2159/213
Coronary IssuesCardiac disorders3/2157/213

Baseline characteristics

Age, Continuous
Age, Continuous(years)Pharmacist CVDEducation ControlTotal
Mean60.9 ± 8.461.5 ± 8.961.2 ± 8.7
Sex: Female, Male
Sex: Female, Male(Participants)Pharmacist CVDEducation ControlTotal
Female333265
Male182181363
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)Pharmacist CVDEducation ControlTotal
White93106199
Black111102213
Other10414
Refused/Missing112
Region of Enrollment
Region of Enrollment(participants)Pharmacist CVDEducation ControlTotal
United States215213428
08

Study locations

1 site
  • Durham VA Medical Center, Durham, NC
    Durham, North Carolina 27705-3875, United States
09

References and documents

Publications

  • Goldstein KM, Stechuchak KM, Zullig LL, Oddone EZ, Olsen MK, McCant FA, Bastian LA, Batch BC, Bosworth HB. Impact of Gender on Satisfaction and Confidence in Cholesterol Control Among Veterans at Risk for Cardiovascular Disease. J Womens Health (Larchmt). 2017 Jul;26(7):806-814. doi: 10.1089/jwh.2016.5739. Epub 2017 Feb 13. PubMed 28192012 ↗
  • Goldstein KM, Oddone EZ, Bastian LA, Olsen MK, Batch BC, Washington DL. Characteristics and Health Care Preferences Associated with Cardiovascular Disease Risk among Women Veterans. Womens Health Issues. 2017 Nov-Dec;27(6):700-706. doi: 10.1016/j.whi.2017.08.002. Epub 2017 Sep 8. PubMed 28890128 ↗
  • Bosworth HB, Olsen MK, McCant F, Stechuchak KM, Danus S, Crowley MJ, Goldstein KM, Zullig LL, Oddone EZ. Telemedicine cardiovascular risk reduction in veterans: The CITIES trial. Am Heart J. 2018 May;199:122-129. doi: 10.1016/j.ahj.2018.02.002. Epub 2018 Feb 10. PubMed 29754649 ↗
  • Melnyk SD, Zullig LL, McCant F, Danus S, Oddone E, Bastian L, Olsen M, Stechuchak KM, Edelman D, Rakley S, Morey M, Bosworth HB. Telemedicine cardiovascular risk reduction in veterans. Am Heart J. 2013 Apr;165(4):501-8. doi: 10.1016/j.ahj.2012.08.005. Epub 2013 Feb 28. PubMed 23537965 ↗
  • Zullig LL, Melnyk SD, Stechuchak KM, McCant F, Danus S, Oddone E, Bastian L, Olsen M, Edelman D, Rakley S, Morey M, Bosworth HB. The Cardiovascular Intervention Improvement Telemedicine Study (CITIES): rationale for a tailored behavioral and educational pharmacist-administered intervention for achieving cardiovascular disease risk reduction. Telemed J E Health. 2014 Feb;20(2):135-43. doi: 10.1089/tmj.2013.0145. Epub 2013 Dec 4. PubMed 24303930 ↗
  • Zullig LL, Stechuchak KM, Goldstein KM, Olsen MK, McCant FM, Danus S, Crowley MJ, Oddone EZ, Bosworth HB. Patient-reported medication adherence barriers among patients with cardiovascular risk factors. J Manag Care Spec Pharm. 2015 Jun;21(6):479-85. doi: 10.18553/jmcp.2015.21.6.479. PubMed 26011549 ↗
  • Palmer MJ, Machiyama K, Woodd S, Gubijev A, Barnard S, Russell S, Perel P, Free C. Mobile phone-based interventions for improving adherence to medication prescribed for the primary prevention of cardiovascular disease in adults. Cochrane Database Syst Rev. 2021 Mar 26;3(3):CD012675. doi: 10.1002/14651858.CD012675.pub3. PubMed 33769555 ↗
  • Ulmer CS, McCant F, Stechuchak KM, Olsen M, Bosworth HB. Prevalence of insomnia disorder and sleep apnea in a sample of veterans at risk for cardiovascular disease. J Clin Sleep Med. 2021 Jul 1;17(7):1441-1446. doi: 10.5664/jcsm.9228. PubMed 33688827 ↗
  • Zullig LL, Oakes MM, McCant F, Bosworth HB. Lessons learned from two randomized controlled trials: CITIES and STOP-DKD. Contemp Clin Trials Commun. 2020 Jul 8;19:100612. doi: 10.1016/j.conctc.2020.100612. eCollection 2020 Sep. Erratum In: Contemp Clin Trials Commun. 2020 Dec 10;20:100690. doi: 10.1016/j.conctc.2020.100690. PubMed 32685766 ↗
  • Goldstein KM, Melnyk SD, Zullig LL, Stechuchak KM, Oddone E, Bastian LA, Rakley S, Olsen MK, Bosworth HB. Heart matters: Gender and racial differences cardiovascular disease risk factor control among veterans. Womens Health Issues. 2014 Sep-Oct;24(5):477-83. doi: 10.1016/j.whi.2014.05.005. PubMed 25213741 ↗

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01142908
Lead sponsor
VA Office of Research and Development
Responsible party
Sponsor
First posted
Jun 11, 2010
Start date
Nov 1, 2011
Primary completion
Apr 30, 2015
Completion
May 22, 2015
Results posted
May 9, 2016
Last update
Jul 27, 2023

Study contacts

Hayden B Bosworth, PhD
principal investigator · Durham VA Medical Center, Durham, NC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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