PASSReviewer 1· 95% conf
The trial design is rigorous with clear randomization, blinding of outcome assessors, pre-specified eligibility criteria, and a power analysis.
Evidence
direct quote[Methods, Trial Design and Eligibility Criteria]
“Those eligible who provided informed consent were randomized 1:1:1 in blocks of nine to one of the three trial arms using the randomization module in REDCap.”direct quote[Methods, Data Collection and Study Outcomes]
“Study staff not involved with the intervention program and blinded to study arm conducted home visits at 6 and 12 months after enrollment in all three arms to collect outcome data.”direct quote[Methods, Sample Size]
“With a target enrollment of 774 participants (258 per arm), we had >80% power to detect a 5 mmHg difference between arms in mean systolic BP at 6 months, allowing for 20% loss to follow-up, a correlation between baseline and follow-up measurements of 0.5, and a two-tailed alpha of 2.5% to account for multiple comparisons between the SOC and both intervention arms.”PASSReviewer 2· 95% conf
The trial design is rigorous with clear randomization, blinding of outcome assessors, pre-specified eligibility criteria, and a power analysis.
Evidence
direct quote[Methods, Trial Design and Eligibility Criteria]
“Those eligible who provided informed consent were randomized 1:1:1 in blocks of nine to one of the three trial arms using the randomization module in REDCap.”direct quote[Methods, Data Collection and Study Outcomes]
“Study staff not involved with the intervention program and blinded to study arm conducted home visits at 6 and 12 months after enrollment in all three arms to collect outcome data.”direct quote[Methods, Sample Size]
“With a target enrollment of 774 participants (258 per arm), we had >80% power to detect a 5 mmHg difference between arms in mean systolic BP at 6 months, allowing for 20% loss to follow-up, a correlation between baseline and follow-up measurements of 0.5, and a two-tailed alpha of 2.5% to account for multiple comparisons between the SOC and both intervention arms.”