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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sundar Natarajan, Narrows Institute for Biomedical Research
ClinicalTrials.gov Identifier:
NCT01043354
First received: January 5, 2010
Last updated: December 6, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Hypercholesterolemia
 Behavioral: stage-matched intervention
Behavioral: framing effects intervention
Behavioral: attention placebo intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: TACTICS (Targeting Adherence to Cholesterol-lowering Therapy to Improve Control Study)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Narrows Institute for Biomedical Research:

Primary Outcome Measures:
  • LDL control [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • medication adherence [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • diet adherence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • exercise adherence [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 246
Study Start Date: September 2008
Estimated Study Completion Date: March 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01043354

Locations
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
Investigators
Principal Investigator: Sundar Natarajan, MD, M.Sc. VA New York Harbor Healthcare System
  More Information

No publications provided

Responsible Party: Sundar Natarajan, Attending Physician, Narrows Institute for Biomedical Research
ClinicalTrials.gov Identifier: NCT01043354     History of Changes
Other Study ID Numbers: ADA 7-08-CR-68
Study First Received: January 5, 2010
Last Updated: December 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Narrows Institute for Biomedical Research:
cholesterol
diabetes
adherence

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 22, 2013