Evaluating Strategies to Control Hypercholesterolemia
Primary Purpose
Cardiovascular Diseases, Heart Diseases, Hypercholesterolemia
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00005350
First Posted
May 25, 2000
Last Updated
December 21, 2015
Sponsor
National Bureau of Economic Research, Inc.
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00005350
Brief Title
Evaluating Strategies to Control Hypercholesterolemia
Study Type
Observational
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
April 1991 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 1993 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Bureau of Economic Research, Inc.
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief Summary
To determine the cost-effectiveness of alternative strategies for cholesterol reduction.
Detailed Description
BACKGROUND:
The availability of effective treatment for hypercholesterolemia raised the hope that millions of Americans could avoid or postpone the development of heart disease. Because the interventions were potentially effective but were also costly, the cost-effectiveness of alternative approaches to detecting and treating hypercholesterolemia had become a critical issue for health policy.
The study was part of a three-grant initiative, Cost-Effective Strategies of Cholesterol-Lowering, which was recommended by the Arteriosclerosis, Hypertension, and Lipid Metabolism Advisory Committee in January, 1988 and given concept clearance at the September, 1988 National Heart, Lung, and Blood Advisory Council. The Request for Applications was released in March, 1990 and awards made in April, 1991.
DESIGN NARRATIVE:
Assessments were made of: effects of treatment on health outcomes (symptomatic coronary heart disease, death from coronary heart disease, and mortality from all causes); costs and effectiveness of specific dietary and pharmacological interventions; effects of delays in instituting treatment; effects of changing the interval between blood cholesterol tests on the probability and duration of treatment delay; cost and health consequences of modifying screening and treatment recommendations for other risk factors, age, and gender; population implications of screening and treatment strategies. Data from the Framingham Heart Study were used to estimate the time pattern of cholesterol levels, which was fundamental to the evaluation of changing the interval between cholesterol tests. Framingham data were also used to estimate the relation of event rates to blood cholesterol levels. Several components of the analysis were validated by testing model predictions against data from the Multiple Risk Factor Intervention Trial. The cost estimates were based on several additional sources. Individual-level cost-effectiveness estimates for several different interventions were presented along with population-level projections of the consequences of alternative strategies. The significance of altering assumptions about uncertain values, such as the long-term risks and benefits of specific medications, was tested in sensitivity analyses.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Heart Diseases, Hypercholesterolemia
7. Study Design
10. Eligibility
Sex
Male
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
12. IPD Sharing Statement
Citations:
PubMed Identifier
7856157
Citation
Browner WS, Baron RB, Solkowitz S, Adler LJ, Gullion DS. Physician management of hypercholesterolemia. A randomized trial of continuing medical education. West J Med. 1994 Dec;161(6):572-8.
Results Reference
background
PubMed Identifier
8441219
Citation
Hulley SB, Newman TB, Grady D, Garber AM, Baron RB, Browner WS. Should we be measuring blood cholesterol levels in young adults? JAMA. 1993 Mar 17;269(11):1416-9.
Results Reference
background
PubMed Identifier
8602715
Citation
Garber AM, Browner WS, Hulley SB. Cholesterol screening in asymptomatic adults, revisited. Part 2. Ann Intern Med. 1996 Mar 1;124(5):518-31. doi: 10.7326/0003-4819-124-5-199603010-00013.
Results Reference
background
Learn more about this trial
Evaluating Strategies to Control Hypercholesterolemia
We'll reach out to this number within 24 hrs