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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Hong Kong, Hong Kong
- 5 public hospitals in Hong Kong
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 1
Lifestyle and compliance counseling via telephone contact with structured set of questions and reinforcements provided
|
for lifestyle and compliance counseling
|
|
Inget ingripande: 2
Control arm with usual care as per local hospital practice
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
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.
Tidsram: 24 months
|
24 months
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Cardiovascular endpoints
Tidsram: 24 months
|
24 months
|
|
Number of hospital admissions, total number of days of hospitalization
Tidsram: 24 months
|
24 months
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Wing Yee So, MRCP, FRCP, Chinese University of Hong Kong
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Telephone intervention
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