Clinical trial NCT04789876: Effectiveness of The Phosphate Mobile App on Serum Phosphorus in Adult Hemodialysis Patients With Hyperphosphatemia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperphosphatemia
End Stage Renal Disease on Dialysis
Keywords: Hemodialysis
Hyperphosphatemia
Mobile app
Dietary counseling
Serum phosphorus
Phosphate knowledge
Dietary intake
Phosphate binder adherence
Lead sponsor: Taylor's University
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in serum phosphorus
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Changes in phosphate knowledge
timeFrame: Baseline, 12 weeks
measure: Changes in dietary intake
timeFrame: Baseline, 12 weeks
measure: Changes in phosphate binder adherence
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
city: Batu Caves
country: Malaysia
facility: Pusat Rawatan Dialisis Islah
state: Selangor
city: Petaling Jaya
country: Malaysia
facility: National Kidney Foundation Malaysia
state: Selangor
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur
Study officials:
affiliation: Taylor's University
name: Tilakavati Karupaiah, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Taylor's University
name: Teong Lee Fang, BSc
role: STUDY_CHAIR
References:
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citation: Reddy V, Symes F, Sethi N, Scally AJ, Scott J, Mumtaz R, Stoves J. Dietitian-led education program to improve phosphate control in a single-center hemodialysis population. J Ren Nutr. 2009 Jul;19(4):314-20. doi: 10.1053/j.jrn.2008.11.001.
citation: Vrdoljak I, Panjkota Krbavcic I, Bituh M, Leko N, Pavlovic D, Vrdoljak Margeta T. The impact of education and cooking methods on serum phosphate levels in patients on hemodialysis: 1-year study. Hemodial Int. 2017 Apr;21(2):256-264. doi: 10.1111/hdi.12468. Epub 2016 Aug 16.