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TACTICS (Targeting Adherence to Cholesterol-lowering Therapy to Improve Control Study) (TACTICS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01043354
Recruitment Status : Completed
First Posted : January 6, 2010
Last Update Posted : April 2, 2014
Information provided by (Responsible Party):
Sundar Natarajan, Narrows Institute for Biomedical Research

Brief Summary:


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.


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.


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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Behavioral: stage-matched intervention Behavioral: framing effects intervention Behavioral: attention placebo intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 247 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: TACTICS (Targeting Adherence to Cholesterol-lowering Therapy to Improve Control Study)
Study Start Date : September 2008
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: stage-matched intervention
Transtheoretical Model-based stage-matched intervention
Behavioral: stage-matched intervention
6 monthly tailored telephone-delivered counseling sessions of transtheoretical model-based counseling

Experimental: framing effects intervention
counseling based on prospect theory
Behavioral: framing effects intervention
6 monthly telephone-delivered counseling sessions based on prospect theory

Active Comparator: attention placebo intervention
counseling about general health topics
Behavioral: attention placebo intervention
6 monthly counseling sessions about general health topics

Primary Outcome Measures :
  1. LDL control [ Time Frame: 6 months ]
  2. medication adherence [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. diet adherence [ Time Frame: 6 months ]
  2. exercise adherence [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adults with diabetes
  • 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:

  • Poor short-term survival (< 1 year)
  • Inability to understand English
  • Recent major surgery (< 3 months)
  • Patients temporarily in the area
  • Inability to provide consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01043354

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United States, New York
VA New York Harbor Healthcare System, NY and BK Campuses
New York, New York, United States, 10010
Sponsors and Collaborators
Narrows Institute for Biomedical Research
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Principal Investigator: Sundar Natarajan, MD, M.Sc. VA New York Harbor Healthcare System

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Responsible Party: Sundar Natarajan, Attending Physician, Narrows Institute for Biomedical Research Identifier: NCT01043354     History of Changes
Other Study ID Numbers: ADA 7-08-CR-68
First Posted: January 6, 2010    Key Record Dates
Last Update Posted: April 2, 2014
Last Verified: April 2014

Keywords provided by Sundar Natarajan, Narrows Institute for Biomedical Research:

Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases