None listed
Conditions
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.
Interventions
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 tailor
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.
Sponsors
Macquarie University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed