Feasibility Trial Design
Cross-source consensus on Feasibility Trial Design from 1 sources and 8 claims.
1 sources · 8 claims
Uses
How it works
Dosage & preparation
Preparation
Evidence quality
Highlighted claims
- As a feasibility trial with a small sample over a short duration, the study is not designed or powered to detect intervention effectiveness. — Remote symptom assessment and management via mobile app for adults with chronic kidney disease in Vietnam (SAM-CKD programme): a randomised feasibility trial protocol
- The SAM-CKD trial is designed and reported according to the CONSORT statement extension for randomised pilot and feasibility trials. — Remote symptom assessment and management via mobile app for adults with chronic kidney disease in Vietnam (SAM-CKD programme): a randomised feasibility trial protocol
- The recruitment target was set at 60 participants — a base sample of 50 inflated by 20% to account for anticipated dropouts, consistent with precedents from other CKD feasibility trials. — Remote symptom assessment and management via mobile app for adults with chronic kidney disease in Vietnam (SAM-CKD programme): a randomised feasibility trial protocol
- All analyses follow an intention-to-treat approach, with no imputation of missing data from dropouts. — Remote symptom assessment and management via mobile app for adults with chronic kidney disease in Vietnam (SAM-CKD programme): a randomised feasibility trial protocol
- Outcome assessors are blinded to group assignments to mitigate detection bias, though participant and researcher blinding is not possible. — Remote symptom assessment and management via mobile app for adults with chronic kidney disease in Vietnam (SAM-CKD programme): a randomised feasibility trial protocol
- App usability and acceptability are assessed at week 6 using the 18-item Vietnamese MAUQ, which has three subscales and uses a 7-point Likert scale. — Remote symptom assessment and management via mobile app for adults with chronic kidney disease in Vietnam (SAM-CKD programme): a randomised feasibility trial protocol
- A 2:1 unequal allocation ratio is used so the lead investigator can gain experience delivering the newly developed programme. — Remote symptom assessment and management via mobile app for adults with chronic kidney disease in Vietnam (SAM-CKD programme): a randomised feasibility trial protocol
- If feasibility thresholds are met, findings will inform the design of a fully powered effectiveness trial. — Remote symptom assessment and management via mobile app for adults with chronic kidney disease in Vietnam (SAM-CKD programme): a randomised feasibility trial protocol