Low-dose versus high-dose ursodeoxycholic acid in cystic fibrosis-related cholestatic liver disease. Results of a randomized study with 1-year follow-up.
Study design (if review, criteria of inclusion for studies)
Compare effectiveness of an educational programme with standard care for knowledge about nutrition. Sequence of randomisation used a random number table. Parallel RCT.
Participants
Number randomised N = 59 (30 in intervention group and 29 in the control group). One family dropped out in each group. Sample analysed comprised : 21 children aged 6 - 11 years and 28 carers in control group and 21 children aged 6 - 11 years and 27 carers in intervention group. Included children aged 2 - 11 years with pancreatic insufficiency. Excluded children with liver disease requiring drug therapy, short gut syndrome, enteral tube feeding, marked language delay in children aged 6 - 11 years. Population of interest N = 70.
Interventions
1. Go and Grow with CF education programme a. introductory workshop b. home-based course c. concluding workshop. Over 4-month period.
Outcome measures
1. Nutrition and enzyme knowledge score plus appropriate and inappropriate self-management scores - children. 2. Nutrition and enzyme knowledge score plus appropriate and inappropriate self-management scores - carers. Measurements taken at baseline, immediately post-intervention and 12 months post-intervention.