Cardiovascular DiseaseCHANGENCT00815789
Cholesterol, Hypertension and Glucose Education Study
A study testing Tailored cardiovascular risk management (Nurse-administered ) in people with Cardiovascular Disease and Diabetes, run by Duke University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease, Diabetes
- What is being tested?
- Tailored cardiovascular risk management (Nurse-administered )
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 362 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Dec 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Enrolled in one of the three primary care clinics for at least one year
- Diagnosis ICD (250.xx) in the prior year
- 18 years of age and older.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Health Care System
Durham, North Carolina, 27705
About this study
Official title: Prevention of Cardiovascular Outcomes in African Americans With Diabetes
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.
Read the detailed description
We will recruit eligible subjects who have an upcoming primary care visit with their primary care provider. Subjects will first be mailed letters, signed by a member of their own primary care team (in these clinics, patients are usually under the care of a team and not one physician) or the Clinic Medical Director in the absence of a primary team member, requesting their participation in the study. Subjects can call a toll-free number to request not to be contacted or if they have any questions (opt-out strategy similar to prior studies approved by Duke's IRB). The research assistant will contact the subject by telephone to explain the study, screen for eligibility, arrange an in-person meeting at the clinic to further describe the study, obtain informed consent and interview the subject. Enrollment will be scheduled at a time when individuals will already be coming to their clinic and all subsequent outcome assessment will be obtained from medical records (e.g., blood pressure, Hb A1c, and LDL-C, BMI) and secondary outcomes (e.g., behaviors will be obtained over the telephone).
Upon enrollment, each eligible, consenting subject will be surveyed about demographics, health behaviors (exercise, diet, medication compliance and treatment barriers), social and medical environment (experiences of discrimination, John Henryism, PHQ2, social support and stress, diabetes knowledge and communication). The entire interview would take approximately 60-90 minutes. If the interview cannot be completed at that time, we will ask permission to call the subject at home to complete the interview. After subjects have completed the measurement battery, they will be randomly assigned to be in one of the two groups. The entire study randomization will occur before patient enrollment begins and this will be maintained in a central site away from the enrollment site.
At either a 12-month follow-up visit or via a phone call, all subjects will once again be surveyed (30-60 minutes) to determine secondary outcome variables including changes in health behaviors, and adherence to recommended regimens. In addition, the cost-effectiveness of the intervention will be assessed at the conclusion of the study.
- Conditions
- Cardiovascular Disease, Diabetes
- Being tested
- Tailored cardiovascular risk management (Nurse-administered )
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored cardiovascular risk management (Nurse-administered )Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: Tailored cardiovascular risk management (Nurse-administered ) |
| Control | No intervention | Receive educational material about CVD reduction at baseline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the outcome (SBP, Hb A1c, or LDL) from baseline to the 12 month evaluation.
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionMar 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 362 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- The Kate B. Reynolds Charitable Trust
- Responsible party
- Sponsor
- Investigators
- Hayden B Bosworth, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00815789
- Sponsor's protocol ID
- Pro00006548
- Other IDs
- 64254, Pro00006548
- Acronym
- CHANGE
- Status last verified
- Jul 2014
- First submitted
- 26 Dec 2008
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23816038
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Cardiovascular Outcomes in African Americans With Diabetes
- ClinicalTrials.gov ID
- NCT00815789
- Acronym / sponsor ID
- CHANGE / Pro00006548
- Conditions
- Cardiovascular Disease, Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- The Kate B. Reynolds Charitable Trust
- Study start
- Dec 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 30 Dec 2008 (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.
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.
Detailed description
We will recruit eligible subjects who have an upcoming primary care visit with their primary care provider. Subjects will first be mailed letters, signed by a member of their own primary care team (in these clinics, patients are usually under the care of a team and not one physician) or the Clinic Medical Director in the absence of a primary team member, requesting their participation in the study. Subjects can call a toll-free number to request not to be contacted or if they have any questions (opt-out strategy similar to prior studies approved by Duke's IRB). The research assistant will contact the subject by telephone to explain the study, screen for eligibility, arrange an in-person meeting at the clinic to further describe the study, obtain informed consent and interview the subject. Enrollment will be scheduled at a time when individuals will already be coming to their clinic and all subsequent outcome assessment will be obtained from medical records (e.g., blood pressure, Hb A1c, and LDL-C, BMI) and secondary outcomes (e.g., behaviors will be obtained over the telephone).
Upon enrollment, each eligible, consenting subject will be surveyed about demographics, health behaviors (exercise, diet, medication compliance and treatment barriers), social and medical environment (experiences of discrimination, John Henryism, PHQ2, social support and stress, diabetes knowledge and communication). The entire interview would take approximately 60-90 minutes. If the interview cannot be completed at that time, we will ask permission to call the subject at home to complete the interview. After subjects have completed the measurement battery, they will be randomly assigned to be in one of the two groups. The entire study randomization will occur before patient enrollment begins and this will be maintained in a central site away from the enrollment site.
At either a 12-month follow-up visit or via a phone call, all subjects will once again be surveyed (30-60 minutes) to determine secondary outcome variables including changes in health behaviors, and adherence to recommended regimens. In addition, the cost-effectiveness of the intervention will be assessed at the conclusion of the study.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Tailored cardiovascular risk management (Nurse-administered )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. |
| Control | No intervention | –Receive educational material about CVD reduction at baseline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Enrolled in one of the three primary care clinics for at least one year
- Diagnosis ICD (250.xx) in the prior year
- 18 years of age and older.
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| Tailored cardiovascular risk management (Nurse-administered )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. | Behavioural | Intervention |
Primary outcome
Change in the outcome (SBP, Hb A1c, or LDL) from baseline to the 12 month evaluation.
Time frame: 12 months
1 secondary outcome
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
Time frame: 12 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 15 Nov 2023.
- Derived from this study: PubMed 23816038Crowley 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.
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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.
Hayden B Bosworth, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored cardiovascular risk management (Nurse-administered ) in people with Cardiovascular Disease and Diabetes, run by Duke University 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 3 inclusion and 10 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 15 Nov 2023. 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?
Change in the outcome (SBP, Hb A1c, or LDL) from baseline to the 12 month evaluation. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00815789, which also lists 1 linked publication.
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 15 Nov 2023.