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Case Managers for CVD Risk Reduction in HIV Clinic
NA trial testing Telephone in Cardiovascular Disease in 50 participants. Completed in 14 September 2023.
| Lead sponsor | Duke University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 50 |
| Start date | 12 October 2020 |
| Primary completion | 14 September 2023 |
| Estimated completion | 14 September 2023 |
| Sites | 1 location across United States |
Duke University
Adults 40 to 75, any sex, with Cardiovascular Disease or HIV. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Educational Pamphlets + Telephone | 1.9 | ± 15.0 |
| Educational Pamphlets | -10.7 | ± 10.9 |
| Group | Value | 95% CI |
|---|---|---|
| Educational Pamphlets + Telephone | 7 | |
| Educational Pamphlets | 10 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Educational Pamphlets + Telephone | -5.7 | ± 36.2 |
| Educational Pamphlets | -1.5 | ± 37.4 |
Total change in body weight from baseline over the study period. Reported here is the change from baseline to 72 weeks.
| Group | Value | 95% CI |
|---|---|---|
| Educational Pamphlets + Telephone | -1.8 | ± 5.1 |
| Educational Pamphlets | -2.1 | ± 4.8 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Educational Pamphlets + Telephone | -1.0 | ± 4.1 |
| Educational Pamphlets | -0.4 | ± 3.3 |
Time frame: Up to 72 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Educational Pamphlets + Te… | Educational Pamphlets |
|---|---|---|---|
| incarcerated inguinal hernia | Gastrointestinal disorders | — | — |
| deep venous thrombosis | Blood and lymphatic system disorders | — | — |
| epididimytis | Reproductive system and breast disorders | — | — |
| stroke | Nervous system disorders | — | — |
| suicidal ideation | Psychiatric disorders | — | — |
| auditory hallucinations | Psychiatric disorders | — | — |
| rhabdomyolysis | Musculoskeletal and connective tissue disorders | — | — |
| gastroenteritis | Gastrointestinal disorders | — | — |
| colonic polyps | Gastrointestinal disorders | — | — |
| esophageal mass | Gastrointestinal disorders | — | — |
| syncope | Cardiac disorders | — | — |
| Reaction | System | Educational Pamphlets + Te… | Educational Pamphlets |
|---|---|---|---|
| colonoscopy | Surgical and medical procedures | — | — |
| cataract surgery | Surgical and medical procedures | — | — |
| assault | Social circumstances | — | — |
| anal condyloma | Gastrointestinal disorders | — | — |
| direct laryngoscopy | Surgical and medical procedures | — | — |
| upper endoscopy | Surgical and medical procedures | — | — |
| laryngeal mass | Respiratory, thoracic and mediastinal disorders | — | — |
| hip replacement | Surgical and medical procedures | — | — |
| COVID-19 | Infections and infestations | — | — |
| gonorrhea | Infections and infestations | — | — |
| scapular abscess | Infections and infestations | — | — |
| transurethral prostatectomy | Surgical and medical procedures | — | — |
| inguinal hernia | Gastrointestinal disorders | — | — |
Most-reported serious reactions: incarcerated inguinal hernia, deep venous thrombosis, epididimytis, stroke, suicidal ideation, auditory hallucinations, rhabdomyolysis, gastroenteritis.
Data from ClinicalTrials.gov NCT03839394 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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