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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Hyperphosphatemia, End Stage Renal Disease on Dialysis

Intervention / Treatment
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* Other: Phosphate mobile app
* Behavioral: One-off dietary counselling with a phosphate booklet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients were allocated to the intervention and control group. The intervention group received a phosphate mobile app for 12 weeks and the control group received one-off dietary counselling delivered by a dietitian with a phosphate booklet.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: App Intervention Group (AIG)<br>Phosphate mobile app for 12 weeks. | Other: Phosphate mobile app<br>* 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.<br>* Other names: MyKidneyDiet - Phosphate Tracker;|
| Active Comparator: Dietitian Intervention Group (DIG)<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in serum phosphorus | Effect of intervention on serum phosphorus | Baseline, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Baseline, 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mobile app, Hemodialysis, Hyperphosphatemia, Dietary counseling, Serum phosphorus, Phosphate knowledge, Dietary intake, Phosphate binder adherence