Findings of SPRINT India trial, a multicentre, randomised-controlled trial of semi-interactive mobile health interventions among stroke patients, revealed that a structured semi-interactive stroke prevention package improved lifestyle behavioral factors and adherence to medication.
Done across 31 stroke centres, including 13 government hospitals in India, the study was published in Lancet Global Health on February 14. The trial was done under ICMR’s Indian Stroke Clinical Trial Network (INSTRuCT), a network of stroke-ready centres in India.
According to the ICMR, this is the first large randomised trial to use a structured education package aimed to reduce stroke recurrence and mortality in stroke survivors. The package included text messages (SMSes), health education videos, and a stroke prevention workbook for patients in 12 languages. Compared with routine care, while this approach did not improve primary outcomes, there was an improvement in some lifestyle behavioural factors and medication compliance.
Stroke (brain attack) is one of the leading causes of death and disability in India. High blood pressure, uncontrolled blood sugar, high cholesterol, smoking, obesity, alcohol intake, lack of exercise and unhealthy diet are the other reasons for stroke. In addition, after a stroke about 20% of the patients in India develop another stroke (recurrence). The main reasons for recurrence are discontinuing medicines apart from the other risk factors.
What the messages said?
The messages focused on controlling the risk factors, improving physical activity, eating a healthy diet, and adherence to medicines to prevent stroke. A total of 4.298 patients were randomly allocated to the intervention arm (2,148) and control arm (2,150) during the study period — between April 28, 2018, and November 30, 2021. 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.
“As many as 1,502 patients in the intervention arm and 1,536 patients in the control arm completed one year of follow-up. The trial used complex behavioural interventions to reduce the recurrence of stroke. The results revealed that the semi-interactive stroke prevention mobile health packages improved lifestyle behavioural factors and adherence to medications. 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 intervention groups,” stated a note from the ICMR.
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 the proportion of patients who stopped smoking (83%) and alcohol (85%) improved in the intervention group as compared to the control group (78% and 75%, respectively).
“Adherence to medications was also better in the intervention arm (94%) as compared to the control arm (89%). The events like stroke, heart attack, and death did not differ between the two groups (5.5% vs. 4.9%) at one-year follow-up. This may be because the follow-up period was too short or study centres were stroke-ready centres, 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,” the doctor said.
Meenakshi Sharma scientist-G, Non-communicable Diseases Division at the ICMR, said two stroke clinical trials were completed in the ICMR’s INSTRuCT network phase I. “In phase 2, which started in September 2022, four more stroke trials have been initiated by the ICMR,” she said.
