HypercholesterolemiaTACTICSNCT01043354
TACTICS (Targeting Adherence to Cholesterol-lowering Therapy to Improve Control Study)
A study testing stage-matched intervention and framing effects intervention in people with Hypercholesterolemia, run by Narrows Institute for Biomedical Research at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- stage-matched intervention and framing effects intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 247 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Poor short-term survival (< 1 year)
- Inability to understand English
- Recent major surgery (< 3 months)
- Patients temporarily in the area
- Inability to provide consent
Trial locations and contacts
1 site in 1 country.
United States1 site
VA New York Harbor Healthcare System, NY and BK Campuses
New York, New York, 10010
About this 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 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.
Read more
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.
- Conditions
- Hypercholesterolemia
- Being tested
- stage-matched intervention, framing effects intervention, attention placebo intervention
- Keywords
- cholesterol, diabetes, adherence
- Medical subject headings
- Hypercholesterolemia, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stage-matched interventionBehavioural
6 monthly tailored telephone-delivered counseling sessions of transtheoretical model-based counseling
framing effects interventionBehavioural
6 monthly telephone-delivered counseling sessions based on prospect theory
attention placebo interventionBehavioural
6 monthly counseling sessions about general health topics
| Study group | Role | What they receive |
|---|---|---|
| stage-matched intervention | Experimental | Transtheoretical Model-based stage-matched intervention Receives: Behavioral: stage-matched intervention |
| framing effects intervention | Experimental | counseling based on prospect theory Receives: Behavioral: framing effects intervention |
| attention placebo intervention | Active comparator | counseling about general health topics Receives: Behavioral: attention placebo intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL control
Measured: 6 months
medication adherence
Measured: 6 months
Secondary outcomes (2)
diet adherence
Measured: 6 months
exercise adherence
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2010 (estimated)
- Study startSep 2008
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- Narrows Institute for Biomedical Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sundar Natarajan, Narrows Institute for Biomedical Research
- Investigators
- Sundar Natarajan, MD, M.Sc., Principal investigator, VA New York Harbor Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01043354
- Sponsor's protocol ID
- ADA 7-08-CR-68
- Acronym
- TACTICS
- Status last verified
- Apr 2014
- First submitted
- 5 Jan 2010
- Last updated
- 2 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TACTICS (Targeting Adherence to Cholesterol-lowering Therapy to Improve Control Study)
- ClinicalTrials.gov ID
- NCT01043354
- Acronym / sponsor ID
- TACTICS / ADA 7-08-CR-68
- Conditions
- Hypercholesterolemia
- Keywords
- cholesterol, diabetes, adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- Narrows Institute for Biomedical ResearchUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 6 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| stage-matched intervention | Experimental | Behavioral: stage-matched interventionTranstheoretical Model-based stage-matched intervention |
| framing effects intervention | Experimental | Behavioral: framing effects interventioncounseling based on prospect theory |
| attention placebo intervention | Active comparator | Behavioral: attention placebo interventioncounseling about general health topics |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Poor short-term survival (< 1 year)
- Inability to understand English
- Recent major surgery (< 3 months)
- Patients temporarily in the area
- Inability to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stage-matched intervention6 monthly tailored telephone-delivered counseling sessions of transtheoretical model-based counseling | Behavioural | stage-matched intervention |
| framing effects intervention6 monthly telephone-delivered counseling sessions based on prospect theory | Behavioural | framing effects intervention |
| attention placebo intervention6 monthly counseling sessions about general health topics | Behavioural | attention placebo intervention |
Primary outcome
LDL control
Time frame: 6 months
medication adherence
Time frame: 6 months
2 secondary outcomes
diet adherence
Time frame: 6 months
exercise adherence
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sundar Natarajan, MD, M.Sc. principal investigator
VA New York Harbor Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stage-matched intervention and framing effects intervention in people with Hypercholesterolemia, run by Narrows Institute for Biomedical Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LDL control (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2014.