Ignite Creation Date:
2024-05-05 @ 10:09 PM
Last Modification Date:
2024-10-26 @ 10:14 AM
Study NCT ID:
NCT01043354
Status:
COMPLETED
Last Update Posted:
2014-04-02
First Post:
2010-01-05
Brief Title:
TACTICS Targeting Adherence to Cholesterol-lowering Therapy to Improve Control Study
Sponsor:
Narrows Institute for Biomedical Research
Organization:
Narrows Institute for Biomedical Research
Study Overview
Official Title:
TACTICS Targeting Adherence to Cholesterol-lowering Therapy to Improve Control Study
Status:
COMPLETED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TACTICS
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 control100 mgdL in preventing CVD the control rate is low Poor adherence to treatmentdiet 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
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 control100 mgdL in preventing CVD the control rate is low Poor adherence to treatmentdiet 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None