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

Not Applicable

Completed

• Conditions: Hyperphosphatemia; End Stage Renal Disease on Dialysis
• Interventions: Other: Phosphate mobile app; Behavioral: One-off dietary counselling with a phosphate booklet

• Registration Number: NCT04789876
• Lead Sponsor: Taylor's University

Brief 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.

Study Timeline

• Study Start: 2019-11-01
• Primary Completion: 2020-02-29
• Study Completion: 2020-02-29
• Status Verified: 2021-03
• Study First Submitted: 2021-03-02
• Study First Submitted QC: 2021-03-08
• Last Update Submitted: 2021-03-08
• Study First Posted: 2021-03-10
• Last Update Posted: 2021-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

• Patients aged 18 years old and above.
• Patients were undergoing maintenance HD treatment for more than three months.
• Patients were on hemodialysis treatment for 4 hours per session, three times a week.
• Kt/V value (a numerical formula value to determine hemodialysis treatment adequacy. K is dialyser clearance of urea, t is dialysis time, and V is the volume of distribution of urea, approximately equal to the patient's total body water) is 1.2 and above each session.
• Patients were able to read English or Malay or Mandarin.
• Patients were on the single type of phosphate binder.
• Patients were having serum phosphorus above 1.78mmol/l and above for more than three months.
• Patients were not seen by a dietitian for the past one year for phosphate education.
• Patients did not have ward admission for the past three months.
• Patients did not have dementia or developmental delay.
• Patients owned and able to use a smartphone.
• Patients were able to use at least one comprehensive mobile application independently.
• Patients had access to the internet/data plan.
• Patients were willing to adhere to all study requirements and protocol.
• Patients were willing to accept the publication of data without exposing their name.

Exclusion Criteria

• Patients were on incremental or acute hemodialysis.
• Patients had ward admission three months prior to the study and during the study period.
• Patients were terminally ill.
• Patients had cognitive impairment or physical disabilities (visual, hand dexterity, etc.) hindering interview and PMA utilisation.
• Patients had visual impairment or blind hindering the interview or the use of PMA.
• Patients were unable to self-care and dependent.
• Patients stayed in an institutionalised setting.
• Patients had undergone parathyroidectomy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
App Intervention Group (AIG)	Phosphate mobile app	Phosphate mobile app for 12 weeks.
Dietitian Intervention Group (DIG)	One-off dietary counselling with a phosphate booklet	One-off 45-minute dietary counselling delivered by a dietitian at the baseline of the study.

Primary Outcome Measures

Name	Time	Method
Changes in serum phosphorus	Baseline, 12 weeks	Effect of intervention on serum phosphorus

Secondary Outcome Measures

Name	Time	Method
Changes in phosphate knowledge	Baseline, 12 weeks	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.
Changes in dietary intake	Baseline, 12 weeks	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.
Changes in phosphate binder adherence	Baseline, 12 weeks	Phosphate binder adherence measured using the 4-item Morisky Medication Adherence Scale (MMAS) at baseline and 12-week after the intervention.

Trial Locations

Locations (3)

Pusat Rawatan Dialisis Islah; 🇲🇾 Batu Caves, Selangor, Malaysia

National Kidney Foundation Malaysia; 🇲🇾 Petaling Jaya, Selangor, Malaysia

Hospital Kuala Lumpur; 🇲🇾 Kuala Lumpur, Malaysia