TACTICS (Targeting Adherence to Cholesterol-lowering Therapy to Improve Control Study)
NCT ID: NCT01043354
Last Updated: 2014-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
247 participants
INTERVENTIONAL
2008-09-30
2012-06-30
Brief Summary
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This is a randomized controlled trial (RCT) of two novel behavioral interventions to enhance treatment adherence and improve low-density lipoprotein cholesterol (LDL) in diabetes. Among adults with diabetes, high LDL greatly increases their risk for cardiovascular disease (CVD). Despite the proven efficacy of LDL control(\<100 mg/dL) in preventing CVD, the control rate is low. Poor adherence to treatment(diet, exercise and medication) is the main reason for this poor control.
Aims: This study will test two telephone-delivered interventions, a Transtheoretical stage-matched intervention (SMI) and a Prospect theory-based framing effects intervention (FEI). The investigators hypothesize that both SMI and FEI will be more effective in improving LDL control than an attention placebo intervention (API) at 6 months. SMI and FEI will also be more effective in increasing adherence to medications, diet and exercise than API at 6 months.
Methods:
The investigators will recruit 246 adults with diabetes and high LDL despite being on medications. Key outcomes are adherence to diet, exercise and medication, and LDL control. The interventions will be standardized and fidelity of intervention maintained. Using a blinded RCT the investigators will test the effect of SMI and FEI compared to API on LDL control and adherence. All analyses will be intent to treat.
Significance:
This project will provide important information to improve diabetes-related behavior and lead to the implementation of novel interventions for lowering LDL in primary care settings among adults with diabetes. It may also provide the scientific rationale to use such approaches to control other risk factors in diabetes.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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stage-matched intervention
Transtheoretical Model-based stage-matched intervention
stage-matched intervention
6 monthly tailored telephone-delivered counseling sessions of transtheoretical model-based counseling
framing effects intervention
counseling based on prospect theory
framing effects intervention
6 monthly telephone-delivered counseling sessions based on prospect theory
attention placebo intervention
counseling about general health topics
attention placebo intervention
6 monthly counseling sessions about general health topics
Interventions
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stage-matched intervention
6 monthly tailored telephone-delivered counseling sessions of transtheoretical model-based counseling
framing effects intervention
6 monthly telephone-delivered counseling sessions based on prospect theory
attention placebo intervention
6 monthly counseling sessions about general health topics
Eligibility Criteria
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Inclusion Criteria
* LDL greater than or equal to 100
* Cholesterol-lowering drug therapy for \> 6 months
* A working telephone
* At least 2 primary care visits in the past 1.5 years
Exclusion Criteria
* Inability to understand English
* Recent major surgery (\< 3 months)
* Patients temporarily in the area
* Inability to provide consent
21 Years
ALL
No
Sponsors
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Narrows Institute for Biomedical Research
OTHER
Responsible Party
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Sundar Natarajan
Attending Physician
Principal Investigators
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Sundar Natarajan, MD, M.Sc.
Role: PRINCIPAL_INVESTIGATOR
VA New York Harbor Healthcare System
Locations
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VA New York Harbor Healthcare System, NY and BK Campuses
New York, New York, United States
Countries
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Other Identifiers
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ADA 7-08-CR-68
Identifier Type: -
Identifier Source: org_study_id
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