Clinical trial NCT01043354: TACTICS (Targeting Adherence to Cholesterol-lowering Therapy to Improve Control Study)
Official title: TACTICS (Targeting Adherence to Cholesterol-lowering Therapy to Improve Control Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Keywords: cholesterol
diabetes
adherence
Lead sponsor: Narrows Institute for Biomedical Research
Sponsor class: OTHER
First posted: 2010-01-06
Enrollment: 247
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: LDL control
timeFrame: 6 months
measure: medication adherence
timeFrame: 6 months
Secondary outcomes:
measure: diet adherence
timeFrame: 6 months
measure: exercise adherence
timeFrame: 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: VA New York Harbor Healthcare System, NY and BK Campuses
state: New York
Study officials:
affiliation: VA New York Harbor Healthcare System
name: Sundar Natarajan, MD, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References: