Cholesterol, Hypertension and Glucose Education Study
CHANGE
Prevention of Cardiovascular Outcomes in African Americans With Diabetes
2 other identifiers
interventional
362
1 country
1
Brief Summary
The goal of this study is to improve cardiovascular disease (CVD) and cholesterol in African Americans adults with diabetes by addressing the modifiable risk factors of systolic blood pressure (SBP), glycosylated hemoglobin (Hb A1c), and low-density lipoprotein cholesterol (LDL-C). We will evaluate the impact of a tailored CVD risk management intervention administered by nurses via the telephone. The intervention incorporates medication management and behavioral modification and will be tailored to the needs of vulnerable high risk subjects (e.g. African Americans, low socioeconomic status, low literate). It will be integrated into community clinics, thereby enhancing the potential for benefit and generalizability to other settings. The primary hypothesis is that among African American subjects with diabetes, a nurse administered, tailored cardiovascular risk management intervention targeting both medication management and behavioral patient self-management will decrease SBP by 5 mmHg, Hb A1c by 0.5%, and LDL-C by 20 mg/dl over 12 months relative to the cardiovascular education-only control group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 26, 2008
CompletedFirst Posted
Study publicly available on registry
December 30, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedNovember 15, 2023
July 1, 2014
2.2 years
December 26, 2008
November 14, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change in the outcome (SBP, Hb A1c, or LDL) from baseline to the 12 month evaluation.
12 months
Secondary Outcomes (1)
Changes in CVD related health behaviors (e.g., aspirin use, medication adherence, exercise, and diet) as well as changes in stroke and CHD risk as assessed by the UPKDS risk engine
12 months
Study Arms (2)
Intervention
EXPERIMENTALA nurse-administered intervention, which includes a behavioral and a medication management component. The intervention consists of very brief monthly telephone calls and occurs over 12 months. Upon request, participants may also be mailed additional supportive educational material to supplement phone intervention. They will also receive a letter clarifying medications reviewed with them during the nurse-administered intervention.
Control
NO INTERVENTIONReceive educational material about CVD reduction at baseline
Interventions
A nurse-administered intervention, which includes a behavioral and a medication management component. The intervention consists of very brief monthly telephone calls and occurs over 12 months. Upon request, participants may also be mailed additional supportive educational material to supplement phone intervention. They will also receive a letter clarifying medications reviewed with them during the nurse-administered intervention.
Eligibility Criteria
You may qualify if:
- Enrolled in one of the three primary care clinics for at least one year
- Diagnosis ICD (250.xx) in the prior year
- years of age and older.
You may not qualify if:
- Hospitalized for a stroke, myocardial infarction, coronary artery revascularization in the past 6 months
- Receiving or planning to receive dialysis for end stage renal disease
- Diagnosis of metastatic cancer
- Active diagnosis of psychosis documented in medical record
- Does not have access to a telephone
- Refusal to provide informed consent
- Resident in nursing home or receiving home health care
- Severely impaired sight, hearing or speech
- Planning to leave the area prior to the anticipated end of participation
- Pregnant or planning to become or breast feeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- The Kate B. Reynolds Charitable Trustcollaborator
Study Sites (1)
Duke University Health Care System
Durham, North Carolina, 27705, United States
Related Publications (1)
Crowley MJ, Powers BJ, Olsen MK, Grubber JM, Koropchak C, Rose CM, Gentry P, Bowlby L, Trujillo G, Maciejewski ML, Bosworth HB. The Cholesterol, Hypertension, And Glucose Education (CHANGE) study: results from a randomized controlled trial in African Americans with diabetes. Am Heart J. 2013 Jul;166(1):179-86. doi: 10.1016/j.ahj.2013.04.004. Epub 2013 May 17.
PMID: 23816038DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hayden B Bosworth, PhD
Duke University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 26, 2008
First Posted
December 30, 2008
Study Start
December 1, 2008
Primary Completion
March 1, 2011
Study Completion
December 1, 2011
Last Updated
November 15, 2023
Record last verified: 2014-07