Primary research aim
To investigate effectiveness, cost-effectiveness, and acceptability of Triple pill (Triple BP lowering therapy) compared to usual care for early management of high BP in India and Sri Lanka.
Research objectives and methodology
Design: Randomised Controlled Trial, Economic Evaluation, and Process Evaluation.
Participants: Adults with high BP despite diet and lifestyle advice or single drug therapy.
Intervention: Triple pill vs. usual care.
Outcome: Proportion of participant achieving target BP at 6 months follow-up.
Sample: n=700, power = 90%, 2α = 0.05, 12% improvement in control rates from 50%.
Current status
Ethics: 16/20 site EC approvals in India + Sydney. Submitted for approval in Sri Lanka.
EC approval: Health Ministry Screening Committee (HMSC): queries answered to satisfaction. Drug Controller General of India (DCGI): Major query answered, awaiting clearance. Awaiting clearance from Faculty of Medicine Ethics Committee, University of Kelaniya, Colombo, Sri Lanka.
Investigators
- Anushka Patel, The George Institute for Global Health, Sydney, Australia
- Anthony Rodgers, The George Institute for Global Health, Sydney, Australia
- Stephen Jan, The George Institute for Global Health, Sydney, Australia
- Ruth Webster, The George Institute for Global Health, Sydney, Australia
- Pallab Maulik, The George Institute for Global Health, Sydney, Australia
- Abdul Salam, The George Institute for Global Health, Sydney, Australia
- Dorairaj Prabhakaran, Centre for Chronic Disease Control, Gurgaon, India
- Simon Thom, Imperial College London, UK
Publications
- Salam A, Webster R, Singh K, Kallakuri S, Rodgers A, Prabhakaran D, et al. TRIple pill vs Usual care Management for Patients with mild-to-moderate Hypertension (TRIUMPH): Study protocol. American heart journal. 2014; 167(2): 127-32
Funding organisations
- National Health and Medical Research Council, Australia
Programme contact
Ruth Webster
rwebster@georgeinstitute.org.au