- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01436136
Reducing Cardiovascular Disease (CVD) Risk in HIV on Antiretroviral Therapy Over 12 Months (CVD)
Effectiveness of Team Intervention Over 12 Months in Reducing Modifiable CVD Risk Factors on Framingham 10yr Risk Scores Outcomes in HIV-1 Subjects on Antiretroviral Therapy
This is a cohort study which follows two groups of participants over a 12 months period. One group will access a team approach to care with the aim of reducing their cardiovascular disease (CVD) risks from a team of doctors, nurses and health care professionals. The other group will continue to access standard care from their treating doctor. Both groups will have CVD risk score evaluated after a 12 month period.
The team care approach will involve specific tests to measure CVD risk as well as smoking cessation, exercise and dietary advice and support, including monitoring such as blood pressure and cholesterol levels
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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New South Wales
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Sydney, New South Wales, Australie, 2010
- Holdsworth House Medical Practice
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
intervention study intervention arm
Inclusion criteria:
- Documented HIV-1 infection
- Age 50 years or older
- Stable on ART ≥ 3/12
- Undetectable plasma HIV RNA (< 50 copies/ml)
- Moderate or high Framingham CVD risk score
- Life expectancy > 12 months
- Regular patient under care of non-director physician
- Willing to adhere to pharmacological CVD risk reduction intervention
- Willing to participate in lifestyle change advice intervention
Exclusion criteria for intervention study
- Life expectancy < 1yr
- Unable to undertake exercise
- Drug dependency
- Cognitive impairment affecting ability to participate in study
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5mI U/ml)
- Women of childbearing potential who are unwilling to use reliable contraception for the duration of the study
Inclusion criteria for intervention study control arm (Group 2)
- Documented HIV-1 infection
- Age 50 years or older
- Stable on ART ≥3/12
- Undetectable plasma HIV RNA (<50 copies/ml)
- Moderate or high Framingham risk score (>10%)
- Life expectancy > 12 months
- Regular patient under care of non-director physician
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur actif: Intervention group
Patients randomised to the intervention group will follow an intensive 52 week period using a clinical protocol aimed to manage CVD risk in HIV individuals with the use of regular visits to a nurse led CVD risk management clinic, within a multi disciplinary approach to care with the involvement of treating physicians, nurses, dieticians, smoking cessation advisors and an exercise physiologist or personal trainer with the aim to reach their individualised CVD risk target.
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GPs managing matched control patients allocated usual care will be unaware of the details of the intervention arm and asked to apply their usual pattern of patient visits and treatment strategies to achieve optimal reduction of CVD risk.
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Comparateur actif: Usual care (control) group
Within the context of an open, cohort study, GPs managing matched control patients allocated usual care will be unaware of the details of the intervention arm and asked to apply their usual pattern of patient visits and treatment strategies to achieve optimal reduction of CVD risk.
|
Patients randomised to the intervention group will follow an intensive 52 week period using a clinical protocol aimed to manage CVD risk in HIV individuals with the use of regular visits to a nurse led CVD risk management clinic, within a multi disciplinary approach to care with the involvement of treating physicians, nurses, dieticians, smoking cessation advisors and an exercise physiologist or personal trainer with the aim to reach their individualised CVD risk target.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
The primary outcome measure is percentage of patients with a reduction of Framingham risk score of at least 10% at week 52.
Délai: 12 months
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The primary outcome measure is percentage of patients with a reduction of Framingham risk score of at least 10% at week 52.
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12 months
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Mark T Bloch, Australian Health Practitioner Regulation Agency
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Reducing CVD risk in HIV
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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