Improving Coronary Prevention in a County Health System

NCT00128687 | Completed DMC

• 2 other identifiers: 240R01HL070781
• Study Type: interventional
• Target: 419
• Locations: 0 countries
• Sites: N/A

Brief Summary

To examine whether the Stanford Health Education and Risk Reduction Training (HEAR2T) program , a case management approach, can be effectively used to manage the risk of coronary artery disease.

Conditions

Cardiovascular Diseases; Coronary Disease; Risk Reduction; Heart Diseases

Outcome Measures

Primary Outcomes (1)

• Framingham Risk Score

  Global Cardiovascular disease (CVD) risk score, according to the 1998 sex-specific Framingham point score algorithms of Wilson et al

  15 months

Study Arms (2)

Immediate Intervention

EXPERIMENTAL

Participants in both arms continue to receive usual medical care throughout the study period. In addition, participants randomized to Immediate Intervention receive intensive case management for Coronary heart disease (CHD) risk reduction for 15 months and then a maintenance program for a minimum of 12 months to assess the durability of initial intervention changes.

Behavioral: risk reduction

Delayed Intervention

PLACEBO COMPARATOR

Participants randomized to Delayed Intervention serve as control for Immediate Intervention patients for the first 15 months and then receive intensive case management for 15 months. The switching-over design not only addresses ethical concerns about withholding treatment from half the study sample, but will also enable us to assess whether the intervention had equal impact whether provided to a naïve population or to a group followed in usual care for 15 months.

Behavioral: risk reduction

Interventions

risk reduction BEHAVIORAL

Participants receive intensive case management for CHD risk reduction for 15 months and then a maintenance program for a minimum of 12 months. Lifestyle modification was strongly emphasized as a critical component of achieving CHD prevention goals. Dietary management was emphasized, including recommendation of a low saturated fat (less than 7% of caloric intake), low cholesterol (\< 150 mg/day), mainly plant-based diet with calorie restrictions for overweight/obese persons. Stress management and coping skills were emphasized, including a regular exercise regimen (≥ 30 minutes of moderate intensity on most days). Cigarette smokers were encouraged to join a stop smoking program.

Delayed Intervention; Immediate Intervention

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient has CAD or CAD risk equivalent (abdominal aortic aneurysm, peripheral vascular disease, transient ischemic attack, stroke, diabetes, or FBS ≥ 126 mg/dL × 2) and has at least one of following: SBP ≥ 130 mmHg, DBP ≥ 80 mmHg, LDL ≥ 100 mg/dL, HDL ≤ 40 mg/dL, TG ≥ 150 mg/dL, FBS ≥ 126 mg/dL, BMI ≥ 30, or is a current smoker.
• The patient does not have CAD or CAD risk equivalent but has at least one of the following: SBP ≥ 160 mmHg, DBP ≥ 100 mmHg, LDL ≥ 190 mg/dL, TC ≥ 240 mg/dL, TG ≥ 500 mg/dL, HbA1c ≥ 8.0%, BMI ≥ 35, or is a current smoker.
• The patient does not have CAD or CAD risk equivalent but has at least two of the following: a) SBP ≥ 140 mmHg or DBP ≤ 90 mmHg, b) HDL ≤ 40 mm/dL or TG ≥ 200 mg/dL, c) LDL ≥ 160 mg/dL or TC ≥ 240 mg/dL, d) FBS ≥ 110 mg/dL × 2, or e) male age ≥ 45 or female age ≥ 55 or with positive family history of CAD.

You may not qualify if:

• Resident of long-term facility
• Lack of spoken English or Spanish by patient or household member 18 years or older who can serve as an interpreter
• Moving before end of intervention (30 months)
• Age between 35 and 85 (inclusive)
• Significant comorbidities such as: uncontrolled metabolic disorders (renal failure, liver failure, etc.), active symptoms suggesting acute myocardial infarction or decompensated congestive heart failure, Malignancy or other condition limiting life expectancy, psychiatric disorder with active manifestations.
• Substance abuse.
• No telephone or means of contacting patient.
• Family household member already enrolled.
• Homeless and not living with relatives/friends.
• Anticipated absence for more than 4 consecutive months.
• Difficulty coming to appointments approximately every 1-2 months
• Already participating in the Diabetes program
• Currently pregnant or intends to get pregnant the next 3 years.

Sponsors & Collaborators

• Stanford University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Related Publications (3)

• Ma J, Berra K, Haskell WL, Klieman L, Hyde S, Smith MW, Xiao L, Stafford RS. Case management to reduce risk of cardiovascular disease in a county health care system. Arch Intern Med. 2009 Nov 23;169(21):1988-95. doi: 10.1001/archinternmed.2009.381.

  PMID: 19933961 DERIVED

• Berra K, Ma J, Klieman L, Hyde S, Monti V, Guardado A, Rivera S, Stafford RS. Implementing cardiac risk-factor case management: lessons learned in a county health system. Crit Pathw Cardiol. 2007 Dec;6(4):173-9. doi: 10.1097/HPC.0b013e31815b5609.

  PMID: 18091408 DERIVED

• Stafford RS, Berra K. Critical factors in case management: practical lessons from a cardiac case management program. Dis Manag. 2007 Aug;10(4):197-207. doi: 10.1089/dis.2007.103624.

  PMID: 17718658 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Coronary Disease; Risk Reduction Behavior; Heart Diseases

Interventions

Numbers Needed To Treat

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Vascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Sample Size; Research Design; Methods; Investigative Techniques

Study Officials

• Randall Stafford

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: August 8, 2005
• First Posted: August 10, 2005
• Study Start: April 1, 2003
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: February 11, 2014

Record last verified: 2014-02