Mobile health (mHealth) refers to the use of mobile and wireless devices to improve health and deliver care. The study was done across 31 stroke centres in India and the trial’s intervention was a package composed of SMS text messages, health education videos and stroke prevention workbooks for patients.
The trial was conducted by SPRINT-India (Secondary Prevention by Structured Semi-Interactive Stroke Prevention Package) under ICMR’s Indian Stroke Clinical Trial Network (INSTRuCT) of stroke-ready centres in India, one of its kind in developing countries and the fourth government-supported network around the world.
Dr Meenakshi Sharma Scientist-G, Noncommunicable Diseases Division, ICMR stated that the SPRINT study is the first trial in India (and perhaps globally) to try to assess the role of an mHealth intervention in secondary prevention of stroke at such a large scale.
It was a multicentre, randomised-controlled trial of a semi-interactive mHealth intervention among stroke patients, the ICMR said in a statement.
The messages given on mobile phones focused on control of blood sugar, blood pressure and cholesterol, improving physical activity, eating a healthy diet and not missing taking medicines to prevent stroke.
The awareness material was systematically developed in 12 different regional languages.
The patients in the control group received standard care whereas those in the intervention arm received awareness material at weekly intervals to promote healthy living and adherence to medicines, the statement said.
A total of 4,298 patients were randomly allocated to the intervention arm (2148) and control arm (2150).
Besides, 1502 patients in the intervention arm and 1536 patients in the control arm completed a one-year follow-up.
The trial used complex behavioral interventions to reduce the recurrence of stroke, the statement stated.
The results of the trial revealed that a structured semi-interactive stroke prevention package improved lifestyle behavioral factors and adherence to medication, which might have long-term benefits.
The trial went a step further than contemporary trials in assessing the effect on endpoints such as the recurrence of cardiovascular events and deaths.
However, the follow-up period was short to show any differences between the control and the intervention groups. The results of the trial were published in the Lancet Global Health journal on 14th February 2023.
Dr Jeyaraj D Pandian, Professor of Neurology and Principal, Christian Medical College, Ludhiana who is the Principal Investigator of the clinical coordinating centre for the trial said that the proportion of patients who stopped smoking (83 pc) and alcohol (85 pc) improved in the intervention group as compared to the control group (78 pc and 75 pc respectively).
Adherence to medications was also better in the intervention arm (94 pc) as compared to the control arm (89 pc). The events like stroke, heart attack and death did not differ between the two groups (5.5 pc vs 4.9 pc) at one-year follow-up.
This may be because the follow-up period was too short or study centres were stroke-ready centers, which were already providing good quality care to stroke patients.
The findings of the SPRINT India trial have a long-term benefit for patients who had a stroke through mobile health interventions.
Dr Meenakshi Sharma said the trial provides hope in improving lifestyle and medical complications by leveraging technology in a resource-constrained setup.
In phase 2 which started in September 2022, four more stroke trials, which are very relevant to the country, have been initiated by ICMR. We would get answers to important treatments for stroke in the coming years.
Stroke (brain attack) is one of the leading causes of death and disability in India. There are two types of stroke; ischemic when there is a blockage in one of the brain arteries and brain hemorrhage when there is rupture and leakage of one of the arteries which supply blood to the brain, the statement said.
High blood pressure is the number one cause of ischemic and hemorrhagic strokes. High blood sugar, high cholesterol, smoking, obesity, alcohol intake, lack of exercise and unhealthy diet are the other reasons why stroke occurs.
In addition, after a stroke about 15 to 20 per cent of the patients in India develop another stroke (recurrence).
The main reasons for recurrence are discontinuing medicines, lack of control of BP, blood sugar, continuing smoking, alcohol intake, following unhealthy food habits, etc.