Type 2 Diabetes MellitusNCT00816010
Telephone Intervention in Patients With Acute Coronary Syndrome (ACS) and Diabetes
A study testing telephone contact in people with Type 2 Diabetes Mellitus and Acute Coronary Syndrome, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Hypothesis To investigate whether telephone counselling by nurse educator between clinic visits with particular emphasis on adherence to medications and lifestyle modification in patients with coronary heart disease and diabetes will reduce mortality and hospitalisation rates due to cardiovascular events compared to… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus, Acute Coronary Syndrome
- What is being tested?
- telephone contact
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteHong Kong
- Study dates
- Jul 2008to Nov 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentre, Randomised Study to Examine the Effects of Telephone Intervention in Patients With Coronary Heart Disease and Diabetes
Hypothesis To investigate whether telephone counselling by nurse educator between clinic visits with particular emphasis on adherence to medications and lifestyle modification in patients with coronary heart disease and diabetes will reduce mortality and hospitalisation rates due to cardiovascular events compared to usual clinic-based care.
Read the detailed description
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.
- Conditions
- Type 2 Diabetes Mellitus, Acute Coronary Syndrome
- Being tested
- telephone contact
- Keywords
- drug compliance, lifestyle modification
- Medical subject headings
- Diabetes Mellitus, Type 2, Acute Coronary Syndrome, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telephone contactBehavioural
for lifestyle and compliance counseling
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Lifestyle and compliance counseling via telephone contact with structured set of questions and reinforcements provided Receives: Behavioral: telephone contact |
| 2 | No intervention | Control arm with usual care as per local hospital practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (2)
Cardiovascular endpoints
Measured: 24 months
Number of hospital admissions, total number of days of hospitalization
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2008 (estimated)
- Study startJul 2008
- Primary completionNov 2010
- Study completionNov 2010
Why it stopped: Due to lack of manpower at the various study sites
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Authority, Hong Kong
- Responsible party
- Principal investigator, Wing-Yee So, Chinese University of Hong Kong
- Investigators
- Wing Yee So, MRCP, FRCP, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00816010
- Sponsor's protocol ID
- Telephone intervention
- Status last verified
- Feb 2012
- First submitted
- 30 Dec 2008
- Last updated
- 22 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomised Study to Examine the Effects of Telephone Intervention in Patients With Coronary Heart Disease and Diabetes
- ClinicalTrials.gov ID
- NCT00816010
- Acronym / sponsor ID
- Telephone intervention
- Conditions
- Type 2 Diabetes Mellitus, Acute Coronary Syndrome
- Keywords
- drug compliance, lifestyle modification
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to lack of manpower at the various study sites
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Hospital Authority, Hong Kong
- Study start
- Jul 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 31 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypothesis To investigate whether telephone counselling by nurse educator between clinic visits with particular emphasis on adherence to medications and lifestyle modification in patients with coronary heart disease and diabetes will reduce mortality and hospitalisation rates due to cardiovascular events compared to usual clinic-based care.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: telephone contactLifestyle and compliance counseling via telephone contact with structured set of questions and reinforcements provided |
| 2 | No intervention | –Control arm with usual care as per local hospital practice |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| telephone contactfor lifestyle and compliance counseling | Behavioural | 1 |
Primary outcome
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.
Time frame: 24 months
2 secondary outcomes
Cardiovascular endpoints
Time frame: 24 months
Number of hospital admissions, total number of days of hospitalization
Time frame: 24 months
Results and safety
The study was stopped early (reason given: Due to lack of manpower at the various study sites). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wing Yee So, MRCP, FRCP principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing telephone contact in people with Type 2 Diabetes Mellitus and Acute Coronary Syndrome, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to lack of manpower at the various study sites). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2012.