Cardiovascular Intervention Improvement Telemedicine Study

NCT01142908 | Completed Results

• 2 other identifiers: IIR 08-29708-297
• Study Type: interventional
• Target: 428
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease; Hypertension; Diabetes; Hyperlipidemia

Keywords

Cardiovascular Disease; Hypertension; Diabetes; Hyperlipidemia; Adherence

Outcome Measures

Primary Outcomes (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 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)

  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)

  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 Outcomes (18)

• Mean Systolic Blood Pressure

  Baseline

• Mean Systolic Blood Pressure

  6 months

• Mean Systolic Blood Pressure

  12 months

• Mean Diastolic Blood Pressure

  Baseline

• Mean Diastolic Blood Pressure

  6 months

Study Arms (2)

Arm 1

EXPERIMENTAL

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

Behavioral: Pharmacist CVD

Arm 2

NO INTERVENTION

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

Interventions

Pharmacist CVD BEHAVIORAL

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

Arm 1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

Location

Related Publications (10)

• 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.

  PMID: 28192012 RESULT

• 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.

  PMID: 28890128 RESULT

• 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.

  PMID: 29754649 RESULT

• 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.

  PMID: 23537965 RESULT

• 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.

  PMID: 24303930 RESULT

• 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.

  PMID: 26011549 RESULT

• 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.

  PMID: 33769555 DERIVED

• 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.

  PMID: 33688827 DERIVED

• 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.

  PMID: 32685766 DERIVED

• 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.

  PMID: 25213741 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Hypertension; Diabetes Mellitus; Hyperlipidemias

Condition Hierarchy (Ancestors)

Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Dyslipidemias; Lipid Metabolism Disorders

Results Point of Contact

• Title: Hayden B. Bosworth, PhD, Assoc Dir, Durham HSR&D COIN
• Organization: Veterans Administration HSRD, Durham COIN

hayden.bosworth@va.gov

919-286-0411

Study Officials

• Hayden B Bosworth, PhD

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2010
• First Posted: June 11, 2010
• Study Start: November 1, 2011
• Primary Completion: April 30, 2015
• Study Completion: May 22, 2015
• Last Updated: July 27, 2023
• Results First Posted: May 9, 2016

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)