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

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ClinicalTrials.gov Identifier: NCT01043354
Recruitment Status : Completed
First Posted : January 6, 2010
Last Update Posted : April 2, 2014
Sponsor:
Information provided by (Responsible Party):
Sundar Natarajan, Narrows Institute for Biomedical Research

Tracking Information
First Submitted Date  ICMJE January 5, 2010
First Posted Date  ICMJE January 6, 2010
Last Update Posted Date April 2, 2014
Study Start Date  ICMJE September 2008
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2010)
  • LDL control [ Time Frame: 6 months ]
  • medication adherence [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01043354 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2010)
  • diet adherence [ Time Frame: 6 months ]
  • exercise adherence [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE TACTICS (Targeting Adherence to Cholesterol-lowering Therapy to Improve Control Study)
Official Title  ICMJE TACTICS (Targeting Adherence to Cholesterol-lowering Therapy to Improve Control Study)
Brief Summary

Background:

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Hypercholesterolemia
Intervention  ICMJE
  • Behavioral: stage-matched intervention
    6 monthly tailored telephone-delivered counseling sessions of transtheoretical model-based counseling
  • Behavioral: framing effects intervention
    6 monthly telephone-delivered counseling sessions based on prospect theory
  • Behavioral: attention placebo intervention
    6 monthly counseling sessions about general health topics
Study Arms
  • Experimental: stage-matched intervention
    Transtheoretical Model-based stage-matched intervention
    Intervention: Behavioral: stage-matched intervention
  • Experimental: framing effects intervention
    counseling based on prospect theory
    Intervention: Behavioral: framing effects intervention
  • Active Comparator: attention placebo intervention
    counseling about general health topics
    Intervention: Behavioral: attention placebo intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 1, 2014)
247
Original Estimated Enrollment  ICMJE
 (submitted: January 5, 2010)
246
Actual Study Completion Date June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01043354
Other Study ID Numbers  ICMJE ADA 7-08-CR-68
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Sundar Natarajan, Narrows Institute for Biomedical Research
Study Sponsor  ICMJE Narrows Institute for Biomedical Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sundar Natarajan, MD, M.Sc. VA New York Harbor Healthcare System
PRS Account Narrows Institute for Biomedical Research
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP