Telephone Intervention in Patients With Acute Coronary Syndrome (ACS) and Diabetes
A Multicentre, Randomised Study to Examine the Effects of Telephone Intervention in Patients With Coronary Heart Disease and Diabetes
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Study-design A 2-year multicentre, randomised controlled open study involving 5 HA hospitals in Hong Kong.
Subjects and method One thousand two hundred and sixteen patients admitted to hospital with principle diagnosis of coronary heart disease and known or newly confirmed diabetes on oral glucose tolerance test will be enrolled. Patients in the intervention arm (n=608) will receive telephone intervention between clinic visits by diabetes nurse educator using structured counselling tools with particular emphasis on adherence to lifestyle modification and medications as well as self-monitoring of blood glucose, blood pressure and body weight. Patients in control group (n=608) will not receive telephone intervention. Both groups will be followed up by their usual medical teams in their hospitals upon discharge.
Clinical endpoints Primary endpoint is the composite of death and/or cardiovascular related hospitalisations. Secondary endpoints include hospitalisations due to cardiovascular events, number of hospital admissions, total number of days of hospital stay and attendance at the Accident and Emergency Department.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
Hong Kong, Hong Kong
- 5 public hospitals in Hong Kong
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Patients admitted to the 5 HA hospitals with principle diagnosis of CHD, age 45 years for male and 55 for female
- Presence of diabetes according to the 1998 WHO criteria and no history of unprovoked ketosis and not requiring continuous insulin treatment within 1 year of diagnosis
Exclusion Criteria:
- Patients with terminal malignancy or other life-threatening diseases with less than 3-month expected survival
- Telephone contact not available
- Patients with a mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
- Patients who speak non-Cantonese dialect or different language or have conditions that prevent effective communications e.g. patients who are deaf and mute
- Patients who live in nursing home with supervised treatment
- Patients who have participated in another intervention study during the last 1 month and who are enrolled in any intervention studies.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 1
Lifestyle and compliance counseling via telephone contact with structured set of questions and reinforcements provided
|
for lifestyle and compliance counseling
|
|
Aucune intervention: 2
Control arm with usual care as per local hospital practice
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Composite endpoint of death and/or CVD related hospitalisations (acute myocardial infarction, revascularisation procedures, heart failure or unstable angina or arrhythmia requiring hospital admissions, lower extremity amputation and stroke) by 24 months.
Délai: 24 months
|
24 months
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Cardiovascular endpoints
Délai: 24 months
|
24 months
|
|
Number of hospital admissions, total number of days of hospitalization
Délai: 24 months
|
24 months
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Wing Yee So, MRCP, FRCP, Chinese University of Hong Kong
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Telephone intervention
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 .