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Simplified Cardiovascular Management Study (SimCard)

Simplified Cardiovascular Management Study: A Cluster-Randomized Trial to Evaluate the Effects of a Simplified Cardiovascular Management Program in Tibet, China and Haryana, India

The goal of this study is to develop, pilot test, and evaluate a highly simplified but guideline-based program for cardiovascular management for application in resource-scarce settings. The study aims to assess the effects of implementing a simple low-cost cardiovascular management program for high-risk individuals, delivered by primary care providers (PCPs) or community health workers (CHWs), on the proportion of patients appropriately treated with diuretics as well as a number of secondary outcomes in resource-scarce Tibet, China and Haryana India.

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

Cardiovascular disease (CVD) is the leading cause of morbidity, mortality, and disability in not only developed, but also developing countries. There are well-established interventions such as lifestyle modification and drug therapies, i.e., aspirin and low-dose diuretics, that along with their consistent use, can help alleviate these burdens if the practicalities of how to deliver such care to large numbers in resource-poor settings at low cost can be resolved. One particular cost-effective approach for secondary prevention of CVD is to identify and manage individuals at high CVD risk in order to prevent or delay events. This approach has been tested in the rural Andhra Pradesh Cardiovascular Prevention Study in India and is currently being implemented in rural areas of northern China in the China Rural Health Initiative funded by NHLBI.

This project aims to address the highly prevalent problem of CVD in even more remote and poor areas of China and India that have received only minimal attention so far, specifically Tibet, China and Haryana, India. This pilot project will be a cluster-randomized controlled interventional trial that will include a total of 15 villages in 6 townships in Gongbujiangda County and 12 villages in 6 townships in Linzhou County in Tibet, China and 12 villages in the state of Haryana in India. The study will last for one year. The villages will be randomized to receive either the intervention package or usual care. At baseline, village-wide screenings will be done to identify high-risk individuals in the selected villages who will then be followed throughout the study to about one year.

The interventional model will make use of a highly simplified cardiovascular disease management plan targeting lifestyle modification and utilization of basic drug regimens to help overcome the barriers in prevention and management of CVD in these areas with extremely limited economic and natural resources, minimal public awareness to the problem, and a lack of trained healthcare professionals.

Electronic blood pressure monitors will be used in all villages to measure the blood pressures of these individuals. However accuracy of the electronic blood pressure monitor measurements needs to be considered due to Tibet's high altitude. A study to validate and calibrate the selected blood pressure monitor model in both plains and high altitude areas will thus be undertaken using the validation procedure published by the European Society of Hypertension (ESH) to ensure accuracy.

Type d'étude

Interventionnel

Inscription (Réel)

2086

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Tibet
      • Lhasa, Tibet, Chine
        • Linzhou
      • Linzhi, Tibet, Chine
        • Gongbujiangda
      • Haryana, Inde
        • Faridabad

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

40 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

Age is equal or older than 40 years old AND the subject has a self-reported history of ANY of the following diseases:

  • CVD OR
  • Diabetes OR
  • Stroke (including both Ischemic Stroke and Haemorrhagic Stroke) OR
  • Measured systolic blood pressure is equal or greater than 160mmHg at two different time points in the same day during the baseline survey.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Aucune intervention: Contrôle (soins habituels)
Contrôler
Expérimental: Intervention
Use of a simplified guideline-based CVD prevention and management scheme by village doctors targeting high risk individuals focusing on a"2+2"model: 2 therapeutic lifestyle recommendations (smoking cessation and salt consumption reduction) plus prescription of 2 low-cost drugs (aspirin and low-dose diuretics) when applicable

This study is a complex pragmatic trial.The intervention includes a "package" of 4 main established measures for cardiovascular prevention and management:

2 therapeutic lifestyle recommendations- smoking cessation (if applicable) and reduced salt consumption

2 drug therapies (if applicable)- hydrochlorothiazide, 25mg tab, 1/2 tab daily (12.5mg/day) and aspirin, 25mg tab, 3 tabs daily (75mg/day)

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Net Difference in Proportion Treated with Low-dose Diuretics
Délai: baseline and at one year
The primary outcome will be the net differences between the changes in the proportion of high-risk individuals treated with low-dose diuretics pre-and-post intervention between intervention and control villages. The outcome measure will be assessed via a questionnaire that will ask about low-dose diuretics usage that will be administered at baseline and then again following the intervention period at around one year.
baseline and at one year

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Net Difference from Baseline in Mean Blood Pressure
Délai: baseline and at one year
The net difference in mean post-intervention blood pressure changes of high-risk patients from baseline between intervention and control villages will be measured. This outcome measure will be taken at baseline and then again following the intervention period at around one year using a standardized electronic blood pressure monitor. Each subject's blood pressure will be taken twice at different time points within the same visit for the baseline measurement and one year follow-up measurement.
baseline and at one year

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Lijing Yan, PhD, The George Institute, China (Beijing, CN)

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 janvier 2012

Achèvement primaire (Réel)

1 mars 2014

Achèvement de l'étude (Réel)

1 septembre 2015

Dates d'inscription aux études

Première soumission

30 décembre 2011

Première soumission répondant aux critères de contrôle qualité

3 janvier 2012

Première publication (Estimation)

4 janvier 2012

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

16 mai 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

15 mai 2017

Dernière vérification

1 août 2014

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 03COE-RA02
  • HHSN268200900027C (Autre subvention/numéro de financement: NHLBI)

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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