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CompletedNCT01043354TACTICSUpdated Apr 2, 2014

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

An interventional study of stage-matched intervention and framing effects intervention in Hypercholesterolemia, sponsored by Narrows Institute for Biomedical Research. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2014-04-02.

Sponsored by Narrows Institute for Biomedical Research · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
247
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hypercholesterolemia

Keywords

  • cholesterol
  • diabetes
  • adherence
03

In context

Hypercholesterolemia

1,175 studies on the registry are indexed under Hypercholesterolemia; 93 are open to participants now.

This study's enrollment of 247 is above the median of 110 across 975 interventional studies indexed under Hypercholesterolemia.

Browse Hypercholesterolemia studies →

Lead sponsor

Narrows Institute for Biomedical Research is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
247 participants (actual)

Study arms

  • Experimental
    stage-matched intervention

    Transtheoretical Model-based stage-matched intervention

    Behavioral: stage-matched intervention

  • Experimental
    framing effects intervention

    counseling based on prospect theory

    Behavioral: framing effects intervention

  • Active comparator
    attention placebo intervention

    counseling about general health topics

    Behavioral: attention placebo intervention

Interventions

  • Behavioralstage-matched intervention

    6 monthly tailored telephone-delivered counseling sessions of transtheoretical model-based counseling

  • Behavioralframing effects intervention

    6 monthly telephone-delivered counseling sessions based on prospect theory

  • Behavioralattention placebo intervention

    6 monthly counseling sessions about general health topics

06

What researchers measure

Primary outcomes

  1. LDL control

    Time frame: 6 months

  2. medication adherence

    Time frame: 6 months

Secondary outcomes

  1. diet adherence

    Time frame: 6 months

  2. exercise adherence

    Time frame: 6 months

07

Study locations

1 site
  • VA New York Harbor Healthcare System, NY and BK Campuses
    New York, New York 10010, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2008, a primary completion of Jun 2012 and a completion of Jun 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 5, 2010
First posted
Jan 6, 2010
Start
Sep 2008
Primary completionActual
Jun 2012
CompletionActual
Jun 2012
Last update
Apr 2, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 2, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01043354
Lead sponsor
Narrows Institute for Biomedical Research
Responsible party
Sundar Natarajan (Attending Physician, Narrows Institute for Biomedical Research) — Principal investigator
First posted
Jan 6, 2010
Start date
Sep 2008
Primary completion
Jun 2012
Completion
Jun 2012
Last update
Apr 2, 2014

Study contacts

Sundar Natarajan, MD, M.Sc.
principal investigator · VA New York Harbor Healthcare System

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

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Discussion

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