NCT01043354

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
247

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2010

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

April 2, 2014

Status Verified

April 1, 2014

Enrollment Period

3.8 years

First QC Date

January 5, 2010

Last Update Submit

April 1, 2014

Conditions

Hypercholesterolemia

Keywords

cholesteroldiabetesadherence

Outcome Measures

Primary Outcomes (2)

  • LDL control

    6 months

  • medication adherence

    6 months

Secondary Outcomes (2)

  • diet adherence

    6 months

  • exercise adherence

    6 months

Study Arms (3)

stage-matched intervention

EXPERIMENTAL

Transtheoretical Model-based stage-matched intervention

Behavioral: stage-matched intervention

framing effects intervention

EXPERIMENTAL

counseling based on prospect theory

Behavioral: framing effects intervention

attention placebo intervention

ACTIVE COMPARATOR

counseling about general health topics

Behavioral: attention placebo intervention

Interventions

stage-matched interventionBEHAVIORAL

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

stage-matched intervention
framing effects interventionBEHAVIORAL

6 monthly telephone-delivered counseling sessions based on prospect theory

framing effects intervention
attention placebo interventionBEHAVIORAL

6 monthly counseling sessions about general health topics

attention placebo intervention

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Poor short-term survival (\< 1 year)
  • Inability to understand English
  • Recent major surgery (\< 3 months)
  • Patients temporarily in the area
  • Inability to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA New York Harbor Healthcare System, NY and BK Campuses

New York, New York, 10010, United States

Location

MeSH Terms

Conditions

HypercholesterolemiaDiabetes Mellitus

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersEndocrine System Diseases

Study Officials

  • Sundar Natarajan, MD, M.Sc.

    VA New York Harbor Healthcare System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

January 5, 2010

First Posted

January 6, 2010

Study Start

September 1, 2008

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

April 2, 2014

Record last verified: 2014-04

Locations

US(1)