Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000388910
Ethics application status
Approved
Date submitted
13/04/2011
Date registered
14/04/2011
Date last updated
10/05/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
The utility of mobile phone in the prevention of coronary heart disease, through lifestyle modification – a prospective, randomised, controlled clinical trial
Scientific title
To assess the effectiveness of lifestyle modification messages delivered by SMS to patients following non-fatal cardiac events in reducing the frequency of future hospitalization for cardiovascular illness, and cardiac as well as all-cause mortality, Karachi Pakistan
Secondary ID [1] 259995 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Mobile Phone to Prevent Cardiovascular Diseases (MoPCVD)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Heart Disease 265647 0
Cardiac Rehabilitaion 265648 0
Condition category
Condition code
Cardiovascular 265776 265776 0 0
Coronary heart disease
Physical Medicine / Rehabilitation 265777 265777 0 0
Other physical medicine / rehabilitation
Public Health 265778 265778 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The mobile phones will be used to deliver Positive Behavioral Change/Positive Life style modification health messages by SMS, MMS, and Voice messages (especially for those who cannot read the text messages). These messages will be tailored to individual intervention group participants, using their name, and incorporating information specific to personal goals, culture, gender, age, and current health status.
Generic cardiovascular health messages are delivered 4 days/week and individually tailored, specific messages 2 days/week.
The duration of the intervention will vary for the enrolled patients, as patients who will be enrolled at the initial phase of the study will have longer duration of the intervention it can be more than 12 months, but we intend to provide intervention to the last patient that we enroll for at least six months. The minimum intervention period is six months, and maximum period is 18 months.
Intervention code [1] 264410 0
Rehabilitation
Intervention code [2] 264411 0
Prevention
Intervention code [3] 264412 0
Lifestyle
Comparator / control treatment
No mobile phone behavioural change message through SMS/MMS/voiceMail, without any interference in the standard of care.
Control group
Active

Outcomes
Primary outcome [1] 266530 0
Mortality due to cardiovascular and related events as assessed by data linkage to medical records
Timepoint [1] 266530 0
After Every 3 months after randomization (3, 6, 9, 12, 15 and 18 months, time point will varies for the patients according to the time of recruitment in the study), minimum of six months for the last patient recruited in the study
Primary outcome [2] 266531 0
All cause mortality as assessed by data linkage to medical records
Timepoint [2] 266531 0
After Every 3 months after randomization (3, 6, 9, 12, 15 and 18 months, time point will varies for the patients according to the time of recruitment in the study), minimum of six months for the last patient recruited in the study
Primary outcome [3] 266532 0
Rehospitalisation after participating in the study as assessed by data linkage to medical records, and personal or information given by primary care givers
Timepoint [3] 266532 0
After Every 3 months after randomization (3, 6, 9, 12, 15 and 18 months, time point will varies for the patients according to the time of recruitment in the study), minimum of six months for the last patient recruited in the study
Secondary outcome [1] 273983 0
Normal Blood Pressure
Proportion of patients and primary carer who achieve a normal blood pressure (i.e. 90 - 140/60 - 90 mmHg) as assessed by mercury sphygmomanometer
Timepoint [1] 273983 0
After Every 3 months after randomization (3, 6, 9, 12, 15 and 18 months, time point will varies for the patients according to the time of recruitment in the study), minimum of six months for the last patient recruited in the study
Secondary outcome [2] 273984 0
Normal Lipid Levels
Proportion of patients and carer who achieve;
blood cholesterol (to less than 4 mmol/l or 152 mg/dl)
(or reduction of 25% in total cholesterol, whichever achieves the lower absolute level, may be desirable goal)
Lowering LDL-cholesterol (to less than 2.0 mmol/l or 77 mg/dl)
(or reduction of 30% in LDL-cholesterol, whichever achieves the lower absolute level, may be desirable goal)
Increasing HDL-cholesterol (to more than 1.0 mmol/l or 40 mg/dl)
Timepoint [2] 273984 0
After Every 3 months after randomization (3, 6, 9, 12, 15 and 18 months, time point will varies for the patients according to the time of recruitment in the study), minimum of six months for the last patient recruited in the study
Secondary outcome [3] 273985 0
Physical Activity
Proportion of the patients and carer engaged in Physical Activity, at least for 30 minutes for most of the days, at least for 5 days, per week.
The physical activity will be assessed by the International Physical activity questionnaire (IPAQ)
Timepoint [3] 273985 0
After Every 3 months after randomization (3, 6, 9, 12, 15 and 18 months, time point will varies for the patients according to the time of recruitment in the study), minimum of six months for the last patient recruited in the study
Secondary outcome [4] 273986 0
Healthy Dieatry Habits
Healthy Dietary Habits means reduction in saturated fat, red meat, sweets, and fast foods. Increased consumption of fruits, vegetables and nuts. The dietary habits would be assessed by the structured food frequency questionnaire.
Timepoint [4] 273986 0
After Every 3 months after randomization (3, 6, 9, 12, 15 and 18 months, time point will varies for the patients according to the time of recruitment in the study), minimum of six months for the last patient recruited in the study
Secondary outcome [5] 273987 0
Normal Blood Glucose levels
Proportion of patients and primary carer who achieve normal blood glucose levels (i.e. 3.6 mmol/L (fasting) - 5.8 mmol/L(random)), as assessed by blood analysis.
Timepoint [5] 273987 0
After Every 3 months after randomization (3, 6, 9, 12, 15 and 18 months, time point will varies for the patients according to the time of recruitment in the study), minimum of six months for the last patient recruited in the study
Secondary outcome [6] 273988 0
Quit Tobacco smoking or chewing
Proportion of the patients and carer who remain never smoker, and patients who maintain quitting smoking.
Tobacco use would be assessed by a validated structured questionnaire. We will use the smoking questionnaire developed by the Minnesota Heart Health survey (EPI/MHHP-Surv 005 6/88 Ver 14)
Timepoint [6] 273988 0
After Every 3 months after randomization (3, 6, 9, 12, 15 and 18 months, time point will varies for the patients according to the time of recruitment in the study), minimum of six months for the last patient recruited in the study

Eligibility
Key inclusion criteria
Patients who have been hospitalized at one of the participating tertiary care cardiac specific hospitals - (The Karachi Institute of Heart Disease, and the National Institute of the Cardiovascular Diseases in Karachi, Pakistan) with their first event (non-Fatal MI, CABG, PCI, stable and Unstable Angina)
Be of sound state of mind.
Willing (consent) to participate in the study.
Stable cardiac status on hospital discharge.
Subject must own a personal mobile phone with a SIM/connection registered in their name.
Willing to retain the same SIM/connection for the period of the study, and if had to change the phone number agreed to notify the new number to the study center.
No life threatening significant co-morbidity such as terminal cancer.
Primary care giver, nominated by the consented patient
Care giver willing (consent) to participate in the study
Primary care giver does not have coronary artery disease
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Do not give consent to participate in the study
Not in a stable state of mind
Pregnant females
Don’t have a personal mobile phone and not willing to acquire one.
Life threatening illness, e.g., terminal stage of cancer etc.
Primary care giver have coronary artery disease

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The study subjects will be the diagnosed patients of CAD, admitted in the study participating tertiary care hospitals, and discharged from the hospital in stable condition. Subjects willing to participate, and prepared to give a blood sample for laboratory investigations. We will allocate each participant through randomization, either to intervention group, those who will receive behavioural change/life style modification education through mobile phone, or in the usual standard of care group (non-intervention group, without interfering in their usual treatment).
The research assistants who will recruit the study participants will randomize them by using a sequence of opaque sealed envelopes containing the allocation for each patient. The randomization will be concealed from the research assistants, and created and maintained by the supervisor at Australian School of Advanced Medicine, Macquarie University Sydney, N.S.W. Australia.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The patient allocation will be carried out through permuted block randomization to ensure a balance in the patients to each group. Varying block sizes of 4, 6, and 8 will be used and both the allocation within the blocks and the block order will be randomized to create the allocation table. The research assistants who will recruit the study participants will randomize them by using a sequence of opaque sealed envelopes containing the allocation for each patient. The randomization will be concealed from the research assistants, and created and maintained by the supervisor at Australian School of Advanced Medicine, Macquarie University Sydney, N.S.W. Australia.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/06/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
3400
Accrual to date
Final
Recruitment outside Australia
Country [1] 3383 0
Pakistan
State/province [1] 3383 0
Sindh

Funding & Sponsors
Funding source category [1] 264882 0
University
Name [1] 264882 0
Macquarie University
Country [1] 264882 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Australian school of Advanced Medicine
Macquarie University
Balaclava road, North Ryde, NSW 2109
Country
Australia
Secondary sponsor category [1] 263983 0
None
Name [1] 263983 0
Address [1] 263983 0
Country [1] 263983 0
Other collaborator category [1] 251955 0
Hospital
Name [1] 251955 0
Karachi Institute of Heart Diseases
Address [1] 251955 0
Department of medical research & CME
ST 15, Block 16
Federal B. Area, Karachi 75950
Sindh
Country [1] 251955 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266836 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 266836 0
Macquarie University
Human Research Ethics Commitee
NSW, Sydney
Ethics committee country [1] 266836 0
Australia
Date submitted for ethics approval [1] 266836 0
10/02/2011
Approval date [1] 266836 0
15/04/2011
Ethics approval number [1] 266836 0
5201100109

Summary
Brief summary
PROBLEM STATEMENT: Cardiovascular disease (CVD) is the leading cause of death globally, responsible for 30% of all cause mortality. According to World Health Organization (No. 317, Jan. 2011) 82% of CVD deaths take place in low- and middle-income countries and occur almost equally in men and women. The largest burden is in South Asia (Pakistan, India, Sri Lanka, Bangladesh, Nepal), where it occurs more frequently in much younger ages as compared to the Western population. Preventive strategies (primary and secondary) have been met with limited success due to the cost and difficulty in healthcare delivery. Mobile phone text messaging (SMS/MMS/Voice messages) demonstrates strong potential as a tool for health care improvement for several reasons; it is available in almost every model of mobile phone, the cost is very low, its use is widespread, it does not require great technological expertise, and it is widely applicable to a variety of health behaviors and conditions
METHODOLOGY: Primary Goal: To assess the effectiveness of lifestyle modification messages delivered by SMS/MMS/Voice mail to patients following non-fatal cardiac events in reducing future hospitalizations, nonfatal and fatal cardiovascular events, as well as all-cause mortality.
It is a Prospective, Multicenter, Randomized, Controlled health intervention clinical trial. The patients hospitalized with their first cardiac event (nonfatal MI, CABG, PCI, unstable angina) will be recruited from the participating tertiary care cardiac specific hospitals – the Karachi Institute of Heart Disease and the National Institute of Cardiovascular Diseases in Karachi, Pakistan. We will randomize each participant to either the intervention group, i.e. those who will receive behavioural change/life style modification education through mobile phone, or to the usual standard of care group (control or non-intervention group). The patient allocation will be carried out through permuted block randomization to ensure a balance in the patients to each group. The participants will be requested to nominate a carer (close relative or friend) who are the persons responsible for taking day-to-day care of the patients at home. The carer will be allocated the same group as their respective patients. Those carers will be our primary prevention group and will go through the same examinations and follow ups as the patients (secondary prevention) group.

Based on power analysis a total of 1540 patients (770 in the intervention and 770 non-intervention groups) and their respective carers (n: 1540 as well) will be enrolled over 12 to 16 months. All patients will be followed up for a minimum of 6 to 9 months (range 21 to 6 months).

A regular mobile phone messages (SMS/MMS/Voice mail) regarding lifestyle modification will be delivered to patients of intervention group, and one of their carer. The mobile phone message based rehabilitation program will be structured according to the latest guidelines developed by the WHO for the prevention of cardiovascular disease.

Blood samples will be drawn to investigate lipid profile, HbA1c, blood sugar, and urinary urea creatinine etc at regular designated intervals.
Trial website
Trial related presentations / publications
The study proposal was presented at the faculty meeting by Co-Investigator (Dr. Javed Ismail), as a part requirement of his PhD candidature, at Macquarie University Sydney Australia, on 9th March 2011.
Public notes

Contacts
Principal investigator
Name 32485 0
Address 32485 0
Country 32485 0
Phone 32485 0
Fax 32485 0
Email 32485 0
Contact person for public queries
Name 15732 0
Javed Ismail
Address 15732 0
Australian School of Advanced Medicine
Cardiac health Institute (CHI)
Suite 202, Level 2
2 technology Place
Macquarie University, NSW 2109
Country 15732 0
Australia
Phone 15732 0
(+61 2) 9858 9898
Fax 15732 0
Email 15732 0
[email protected]
Contact person for scientific queries
Name 6660 0
Hosen Kiat
Address 6660 0
Australian School of Advanced Medicine
Cardiac health Institute (CHI)
Suite 202, Level 2
2 technology Place
Macquarie University, NSW 2109
Country 6660 0
Australia
Phone 6660 0
(+61 2) 9858 9898
Fax 6660 0
Email 6660 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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