NCT04789876

Effectiveness of The Phosphate Mobile App on Serum Phosphorus in Adult Hemodialysis Patients With Hyperphosphatemia

A Multicenter, Open-Label, Randomised Controlled Trial Investigating the Effectiveness Of The Phosphate Mobile App on Serum Phosphorus Outcomes In Adult Hemodialysis Patients With Hyperphosphatemia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Taylor's University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This multi-centred randomized, open label-controlled trial consists of hemodialysis (HD) patients identified with hyperphosphatemia (\>1.78mmol/L). The intervention group received a phosphate mobile app and the control group received one-off dietary counselling for 12 weeks. Serum phosphate was measured pre-and post-intervention.

Detailed description

This study is a multi-centred randomized, open label-controlled trial where a total of 66 HD patients (33 intervention vs 33 control) with hyperphosphatemia were recruited from government, private and non-governmental organization settings. Patients who consented were subjected to screening for identification of hyperphosphatemia and other eligibility criteria. Patients who fulfilled the inclusion criteria were grouped according to shift and block randomized to either the intervention or control group using a web-based randomiser. The intervention group received a phosphate mobile app for 12 weeks and the control group received one-off phosphate counselling delivered by a dietitian with a phosphate booklet. During the 12 weeks study period, patients in both control and intervention groups were assessed at baseline and 12 weeks for changes in serum phosphorus, serum corrected calcium, phosphate knowledge, dietary intake and phosphate binder adherence. These parameters were compared at baseline and 12 weeks for within- and between-group.

Conditions

• Hyperphosphatemia
• End Stage Renal Disease on Dialysis

Interventions

Type	Name	Description
OTHER	Phosphate mobile app	The phosphate mobile app has the features of i) matching phosphate binder with dietary phosphate intake, ii) educational videos of phosphate management, iii) food database with local food items, iv) record-keeping and goal setting.
BEHAVIORAL	One-off dietary counselling with a phosphate booklet	One-off 45-minute dietary counselling delivered by a dietitian at the baseline of the study. Patients received a complimentary phosphate booklet after the counselling session. The phosphate booklet contains similar educational information as per the phosphate mobile app excluding the matching of phosphate binder with dietary phosphate information.

Timeline

• Start date: 2019-11-01
• Primary completion: 2020-02-29
• Completion: 2020-02-29
• First posted: 2021-03-10
• Last updated: 2021-03-10

Locations

3 sites across 1 country: Malaysia