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NCT01043354 · ClinicalTrials.gov registry record · NA
TACTICS (Targeting Adherence to Cholesterol-lowering Therapy to Improve Control Study)
A NA study, sponsored by Narrows Institute for Biomedical Research.
- Completed
- Registry status
- NA
- Development phase
- 247
- Enrollment target
NCT01043354: Completed NA study, sponsored by Narrows Institute for Biomedical Research.
NCT01043354 is a NA study that has completed, run by Narrows Institute for Biomedical Research. The registered enrollment target is 247 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01043354, a NA study, has completed, sponsored by Narrows Institute for Biomedical Research.
- COMPLETED
- Registry status
- NA
- Development phase
- 247 participants
- Enrollment target
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.
Interventions
- BEHAVIORAL stage-matched intervention
- BEHAVIORAL framing effects intervention
- BEHAVIORAL attention placebo intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 247 participants |
| Start Date | 2008-09 |
| Est. Completion | 2012-06 |
| Phase | NA |
What the finished NCT01043354 record still lists
NCT01043354 is an interventional study that assigns participants to a tested intervention. The registered 247 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 3 interventions - of which stage-matched intervention is the first listed.
NCT01043354 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01043354 about?
NCT01043354 is a clinical study titled "TACTICS (Targeting Adherence to Cholesterol-lowering Therapy to Improve Control Study)". 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...
What is the current status of trial NCT01043354?
This trial is currently completed. It is a NA study. The enrollment target is 247 participants. The study started on 2008-09. Estimated completion is 2012-06.
What interventions are being tested in trial NCT01043354?
The interventions under investigation include: stage-matched intervention (BEHAVIORAL), framing effects intervention (BEHAVIORAL), attention placebo intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT01043354?
This trial is sponsored by Narrows Institute for Biomedical Research, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01043354's enrollment target sits among peer trials
247 436th of 2000 higher than 1,565 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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