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

Hypercholesterolemia Clinical Trial

— TACTICS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01043354
• Other study ID #: ADA 7-08-CR-68
• Status: Completed
• Phase: N/A
• First received: January 5, 2010
• Last updated: April 1, 2014
• Start date: September 2008
• Est. completion date: June 2012

Study information

• Verified date: April 2014
• Source: Narrows Institute for Biomedical Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 247
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
United States	VA New York Harbor Healthcare System, NY and BK Campuses	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Narrows Institute for Biomedical Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL control		6 months	No
Primary	medication adherence		6 months	No
Secondary	diet adherence		6 months	No
Secondary	exercise adherence		6 months	No