An interventional study of Phosphate mobile app and One-off dietary counselling with a phosphate booklet in Hyperphosphatemia and End Stage Renal Disease on Dialysis, sponsored by Taylor's University. Completed at 3 sites in Malaysia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-10.
Sponsored by Taylor's University · Not applicable, Interventional, and Treatment
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.
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.
2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.
This study's enrollment of 74 is above the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Taylor's University is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Phosphate mobile app for 12 weeks.
Other: Phosphate mobile app
One-off 45-minute dietary counselling delivered by a dietitian at the baseline of the study.
Behavioral: One-off dietary counselling with a phosphate booklet
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.
Also known as: MyKidneyDiet - Phosphate Tracker
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.
Changes in serum phosphorus
Effect of intervention on serum phosphorus
Time frame: Baseline, 12 weeks
Changes in phosphate knowledge
A questionnaire used to assess phosphate knowledge and contained 18 questions related to phosphate treatment, disease pathophysiology, dialysis treatment, phosphate binder, dietary phosphate and responsibility. The questionnaire was an expert validated phosphate questionnaire with back-to-back-translation for English, Malay, and Chinese questionnaire. Each correct response was awarded 1 point, and all correct answers were summed to achieve a total score. The possible total score ranged from 0 to 18. All subjects completed this questionnaire at baseline and 12-week after the intervention.
Time frame: Baseline, 12 weeks
Changes in dietary intake
Dietary energy intake (kcal/day and kcal/kg body weight/day), dietary protein intake (g/day and g/kg body weight/day) and dietary phosphate (mg/day) assessed using a 3-day dietary record method at baseline and 12-week after the intervention.
Time frame: Baseline, 12 weeks
Changes in phosphate binder adherence
Phosphate binder adherence measured using the 4-item Morisky Medication Adherence Scale (MMAS) at baseline and 12-week after the intervention.
Time frame: Baseline, 12 weeks
Plan to share: No
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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