N/A N=428 Randomized Treatment

Cardiovascular Intervention Improvement Telemedicine Study

Cardiovascular Disease · Hypertension · Diabetes · Hyperlipidemia

Bottom Line

View on ClinicalTrials.gov: NCT01142908 ↗

Enrolled (actual)

428

Serious AEs

58.2%

Results posted

May 2016

Primary outcome: Primary: Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent) — 32.4; 31.6 % 10 yr Risk

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Pharmacist CVD (Behavioral)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: Apr 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent)	28.9; 28.4	0.74
PRIMARY Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent)	28.9; 28.4	0.74
PRIMARY Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent)	28.9; 28.4	0.74
SECONDARY Mean Systolic Blood Pressure	128.5; 126.4	0.34
SECONDARY Mean Systolic Blood Pressure	128.5; 126.4	0.34
SECONDARY Mean Systolic Blood Pressure	128.5; 126.4	0.34
SECONDARY Mean Diastolic Blood Pressure	73.4; 73.1	0.70
SECONDARY Mean Diastolic Blood Pressure	73.4; 73.1	0.70
SECONDARY Mean Diastolic Blood Pressure	73.4; 73.1	0.70
SECONDARY Medication Non-adherence	96; 82	0.36
SECONDARY Medication Non-adherence	96; 82	0.36
SECONDARY Medication Non-adherence	96; 82	0.36
SECONDARY Cholesterol LDL	114.4; 115.3	0.79
SECONDARY Cholesterol LDL	114.4; 115.3	0.79
SECONDARY Cholesterol LDL	114.4; 115.3	0.79
SECONDARY Body Mass Index	31.9; 31.6	0.54
SECONDARY Body Mass Index	31.9; 31.6	0.54
SECONDARY Body Mass Index	31.9; 31.6	0.54
SECONDARY HBA1C in Diabetic Patients	7.5; 7.7	0.72
SECONDARY HBA1C in Diabetic Patients	7.5; 7.7	0.72
SECONDARY HBA1C in Diabetic Patients	7.5; 7.7	0.72

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.

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01142908). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.