Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04789876
Status:
COMPLETED
Last Update Posted:
2021-03-10
First Post:
2021-03-02
Brief Title:
Effectiveness of The Phosphate Mobile App on Serum Phosphorus in Adult Hemodialysis Patients With Hyperphosphatemia
Sponsor:
Taylors University
Organization:
Taylors University
Study Overview
Official Title:
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
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This multi-centred randomized open label-controlled trial consists of hemodialysis HD patients identified with hyperphosphatemia 178mmolL 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NMRR-19-3825-45381 | REGISTRY | National Medical Research Register | None |