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| ID | Type | Description | Link |
|---|---|---|---|
| K23HL137611-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The purpose of the study is to assess the efficacy of a case manager/social worker administered, telephone-based educational curriculum in improving cardiovascular disease related outcomes among HIV-infected clinic patients.
Fifty high Cardiovascular Disease Risk (CVD) risk clinic patients will be randomized 1:1 to receive either a series of educational pamphlets on CVD risk reduction plus a telephone-based CVD risk reduction curriculum delivered over 24 weeks [intervention arm], or the educational pamphlets alone [control arm]. Anthropomorphic data, blood pressure and lipid profiles will be obtained from patients to assess the efficacy of the intervention in reducing blood pressure and serum low-density lipoprotein levels (LDL).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Educational pamphlets + telephone | Experimental |
| |
| Educational pamphlets | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telephone | Behavioral | A series of educational pamphlets on CVD risk reduction plus a telephone-based CVD risk reduction curriculum will be administered by Clinic-Based Case Managers (CCMs). Six modules will be given over 24 weeks in a rotating fashion on topics relevant to CVD risk. Subjects will be given the pamphlets every 2 weeks corresponding with the first time they receive the telephone - based module. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Ambulatory Systolic Blood Pressure | Change of systolic blood pressure will be assessed as an absolute continuous variable, and as a proportion or persons who achieve >5mmHg reduction in systolic blood pressure from baseline. Reported here is the change from baseline to 72 weeks. | Baseline, 24 weeks, 48 weeks, 72 weeks |
| Number of Participants Who Achieve >5mmHg Reduction in Systolic Blood Pressure From Baseline | Baseline, 72 weeks | |
| Change in Non-HDL (High Density Lipoprotein Cholesterol) Levels | Assessment of the absolute change in fasting calculated non-high density lipoprotein cholesterol over the study period. Reported here is the change from baseline to 72 weeks. | Baseline, 24 weeks, 48 weeks, 72 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Total Change in Body Weight | Total change in body weight from baseline over the study period. Reported here is the change from baseline to 72 weeks. | Baseline, 24 weeks, 48 weeks, 72 weeks |
| Change in 10-year Atherosclerotic Cardiovascular Disease (ASCVD) Risk Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nwora L Okeke, MD, MPH | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27701 | United States |
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| Label | URL |
|---|---|
| Website referring to educational materials to be shared as part of this intervention | View source |
| Website referring to educational materials to be shared as part of this intervention | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Educational Pamphlets + Telephone | Telephone: A series of educational pamphlets on CVD risk reduction plus a telephone-based CVD risk reduction curriculum will be administered by Clinic-Based Case Managers (CCMs). Six modules will be given over 24 weeks in a rotating fashion on topics relevant to CVD risk. Subjects will be given the pamphlets every 2 weeks corresponding with the first time they receive the telephone - based module. Educational pamphlets: A series of 6 handouts will be given to controls once monthly over 6 months on the same topics presented in the telephone modules. Educational packets will be primarily drawn from free printed material available at www.learningaboutdiabetes.org and the American Heart Association website. |
| FG001 | Educational Pamphlets | Educational pamphlets: A series of 6 handouts will be given to controls once monthly over 6 months on the same topics presented in the telephone modules. Educational packets will be primarily drawn from free printed material available at www.learningaboutdiabetes.org and the American Heart Association website. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Educational Pamphlets + Telephone | Telephone: A series of educational pamphlets on CVD risk reduction plus a telephone-based CVD risk reduction curriculum will be administered by Clinic-Based Case Managers (CCMs). Six modules will be given over 24 weeks in a rotating fashion on topics relevant to CVD risk. Subjects will be given the pamphlets every 2 weeks corresponding with the first time they receive the telephone - based module. Educational pamphlets: A series of 6 handouts will be given to controls once monthly over 6 months on the same topics presented in the telephone modules. Educational packets will be primarily drawn from free printed material available at www.learningaboutdiabetes.org and the American Heart Association website. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Ambulatory Systolic Blood Pressure | Change of systolic blood pressure will be assessed as an absolute continuous variable, and as a proportion or persons who achieve >5mmHg reduction in systolic blood pressure from baseline. Reported here is the change from baseline to 72 weeks. | Participants with data collected at both timepoints. | Posted | Mean | Standard Deviation | mmHg | Baseline, 24 weeks, 48 weeks, 72 weeks |
|
Up to 72 weeks
All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Educational Pamphlets + Telephone | Telephone: A series of educational pamphlets on CVD risk reduction plus a telephone-based CVD risk reduction curriculum will be administered by Clinic-Based Case Managers (CCMs). Six modules will be given over 24 weeks in a rotating fashion on topics relevant to CVD risk. Subjects will be given the pamphlets every 2 weeks corresponding with the first time they receive the telephone - based module. Educational pamphlets: A series of 6 handouts will be given to controls once monthly over 6 months on the same topics presented in the telephone modules. Educational packets will be primarily drawn from free printed material available at www.learningaboutdiabetes.org and the American Heart Association website. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| incarcerated inguinal hernia | Gastrointestinal disorders | SNOMED CT | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cataract surgery | Surgical and medical procedures | SNOMED CT | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nwora Lance Okeke, MD, MPH | Duke University | 919-684-2579 | lance.okeke@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 6, 2023 | Aug 28, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 29, 2021 | Mar 3, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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|
| Educational pamphlets | Other | A series of 6 handouts will be given to controls once monthly over 6 months on the same topics presented in the telephone modules. Educational packets will be primarily drawn from free printed material available at www.learningaboutdiabetes.org and the American Heart Association website. |
|
The global cardiovascular disease risk as calculated by the American College of Cardiology/American Heart Association's 10-year risk calculator. The ASCVD risk score is a calculation of the 10-year risk of having a cardiovascular problem, such as a heart attack or stroke. The ASCVD risk score is given as a percentage, which represents the chance of having heart disease or stroke in the next 10 years. 0 to 4.9 = low risk, 5 to 7.4 = borderline risk, 7.5 to 20 = intermediate risk, >20 = high risk. Reported here is the change from baseline to 72 weeks. |
| Baseline, 24 weeks, 48 weeks, 72 weeks |
| BG001 | Educational Pamphlets | Educational pamphlets: A series of 6 handouts will be given to controls once monthly over 6 months on the same topics presented in the telephone modules. Educational packets will be primarily drawn from free printed material available at www.learningaboutdiabetes.org and the American Heart Association website. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Educational Pamphlets | Educational pamphlets: A series of 6 handouts will be given to controls once monthly over 6 months on the same topics presented in the telephone modules. Educational packets will be primarily drawn from free printed material available at www.learningaboutdiabetes.org and the American Heart Association website. |
|
|
|
| Primary | Number of Participants Who Achieve >5mmHg Reduction in Systolic Blood Pressure From Baseline | Participants with data collected at both timepoints. | Posted | Count of Participants | Participants | Baseline, 72 weeks |
|
|
|
|
| Primary | Change in Non-HDL (High Density Lipoprotein Cholesterol) Levels | Assessment of the absolute change in fasting calculated non-high density lipoprotein cholesterol over the study period. Reported here is the change from baseline to 72 weeks. | Participants with data collected at both timepoints. | Posted | Mean | Standard Deviation | mg/dL | Baseline, 24 weeks, 48 weeks, 72 weeks |
|
|
|
|
| Secondary | Total Change in Body Weight | Total change in body weight from baseline over the study period. Reported here is the change from baseline to 72 weeks. | Participants with data collected at both timepoints. | Posted | Mean | Standard Deviation | kg | Baseline, 24 weeks, 48 weeks, 72 weeks |
|
|
|
|
| Secondary | Change in 10-year Atherosclerotic Cardiovascular Disease (ASCVD) Risk Score | The global cardiovascular disease risk as calculated by the American College of Cardiology/American Heart Association's 10-year risk calculator. The ASCVD risk score is a calculation of the 10-year risk of having a cardiovascular problem, such as a heart attack or stroke. The ASCVD risk score is given as a percentage, which represents the chance of having heart disease or stroke in the next 10 years. 0 to 4.9 = low risk, 5 to 7.4 = borderline risk, 7.5 to 20 = intermediate risk, >20 = high risk. Reported here is the change from baseline to 72 weeks. | Participants with data collected at both timepoints. | Posted | Mean | Standard Deviation | percentage of risk | Baseline, 24 weeks, 48 weeks, 72 weeks |
|
|
|
|
| 0 |
| 25 |
| 3 |
| 25 |
| 9 |
| 25 |
| EG001 | Educational Pamphlets | Educational pamphlets: A series of 6 handouts will be given to controls once monthly over 6 months on the same topics presented in the telephone modules. Educational packets will be primarily drawn from free printed material available at www.learningaboutdiabetes.org and the American Heart Association website. | 0 | 24 | 3 | 24 | 3 | 24 |
| deep venous thrombosis | Blood and lymphatic system disorders | SNOMED CT | Non-systematic Assessment |
|
| epididimytis | Reproductive system and breast disorders | SNOMED CT | Non-systematic Assessment |
|
| stroke | Nervous system disorders | SNOMED CT | Non-systematic Assessment |
|
| suicidal ideation | Psychiatric disorders | SNOMED CT | Non-systematic Assessment |
|
| auditory hallucinations | Psychiatric disorders | SNOMED CT | Non-systematic Assessment |
|
| rhabdomyolysis | Musculoskeletal and connective tissue disorders | SNOMED CT | Non-systematic Assessment |
|
| gastroenteritis | Gastrointestinal disorders | SNOMED CT | Non-systematic Assessment |
|
| colonic polyps | Gastrointestinal disorders | SNOMED CT | Non-systematic Assessment |
|
| esophageal mass | Gastrointestinal disorders | SNOMED CT | Non-systematic Assessment |
|
| syncope | Cardiac disorders | SNOMED CT | Non-systematic Assessment |
|
| assault | Social circumstances | SNOMED CT | Non-systematic Assessment |
|
| anal condyloma | Gastrointestinal disorders | SNOMED CT | Non-systematic Assessment |
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| colonoscopy | Surgical and medical procedures | SNOMED CT | Non-systematic Assessment |
|
| direct laryngoscopy | Surgical and medical procedures | SNOMED CT | Non-systematic Assessment |
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| upper endoscopy | Surgical and medical procedures | SNOMED CT | Non-systematic Assessment |
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| laryngeal mass | Respiratory, thoracic and mediastinal disorders | SNOMED CT | Non-systematic Assessment |
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| hip replacement | Surgical and medical procedures | SNOMED CT | Non-systematic Assessment |
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| COVID-19 | Infections and infestations | SNOMED CT | Non-systematic Assessment |
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| gonorrhea | Infections and infestations | SNOMED CT | Non-systematic Assessment |
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| scapular abscess | Infections and infestations | SNOMED CT | Non-systematic Assessment |
|
| transurethral prostatectomy | Surgical and medical procedures | SNOMED CT | Non-systematic Assessment |
|
| inguinal hernia | Gastrointestinal disorders | SNOMED CT | Non-systematic Assessment |
|
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