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

NCT04789876 | Completed

• 2 other identifiers: HEC 2019/011NMRR-19-3825-45381
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 3

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.

Conditions

Hyperphosphatemia; End Stage Renal Disease on Dialysis

Keywords

Hemodialysis; Hyperphosphatemia; Mobile app; Dietary counseling; Serum phosphorus; Phosphate knowledge; Dietary intake; Phosphate binder adherence

Outcome Measures

Primary Outcomes (1)

• Changes in serum phosphorus

  Effect of intervention on serum phosphorus

  Baseline, 12 weeks

Secondary Outcomes (3)

• Changes in phosphate knowledge

  Baseline, 12 weeks

• Changes in dietary intake

  Baseline, 12 weeks

• Changes in phosphate binder adherence

  Baseline, 12 weeks

Study Arms (2)

App Intervention Group (AIG)

EXPERIMENTAL

Phosphate mobile app for 12 weeks.

Other: Phosphate mobile app

Dietitian Intervention Group (DIG)

ACTIVE COMPARATOR

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

Interventions

Phosphate mobile app OTHER

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

App Intervention Group (AIG)

One-off dietary counselling with a phosphate booklet BEHAVIORAL

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.

Dietitian Intervention Group (DIG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taylor's University: lead

Study Sites (3)

Pusat Rawatan Dialisis Islah

Batu Caves, Selangor, 68100, Malaysia

Location

National Kidney Foundation Malaysia

Petaling Jaya, Selangor, 46100, Malaysia

Location

Hospital Kuala Lumpur

Kuala Lumpur, 50586, Malaysia

Location

Related Publications (8)

• Ketteler M, Block GA, Evenepoel P, Fukagawa M, Herzog CA, McCann L, Moe SM, Shroff R, Tonelli MA, Toussaint ND, Vervloet MG, Leonard MB. Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease-Mineral and Bone Disorder: Synopsis of the Kidney Disease: Improving Global Outcomes 2017 Clinical Practice Guideline Update. Ann Intern Med. 2018 Mar 20;168(6):422-430. doi: 10.7326/M17-2640. Epub 2018 Feb 20.

  PMID: 29459980 BACKGROUND

• Umeukeje EM, Mixon AS, Cavanaugh KL. Phosphate-control adherence in hemodialysis patients: current perspectives. Patient Prefer Adherence. 2018 Jul 4;12:1175-1191. doi: 10.2147/PPA.S145648. eCollection 2018.

  PMID: 30013329 BACKGROUND

• Chan MW, Cheah HM, Mohd Padzil MB. Multidisciplinary education approach to optimize phosphate control among hemodialysis patients. Int J Clin Pharm. 2019 Oct;41(5):1282-1289. doi: 10.1007/s11096-019-00878-4. Epub 2019 Jul 13.

  PMID: 31302884 RESULT

• Milazi M, Bonner A, Douglas C. Effectiveness of educational or behavioral interventions on adherence to phosphate control in adults receiving hemodialysis: a systematic review. JBI Database System Rev Implement Rep. 2017 Apr;15(4):971-1010. doi: 10.11124/JBISRIR-2017-003360.

  PMID: 28398983 RESULT

• Fakih El Khoury C, Crutzen R, Schols JMGA, Halfens RJG, Karavetian M. A Dietary Mobile App for Patients Undergoing Hemodialysis: Prospective Pilot Study to Improve Dietary Intakes. J Med Internet Res. 2020 Jul 20;22(7):e17817. doi: 10.2196/17817.

  PMID: 32706698 RESULT

• Elder GJ, Malik A, Lambert K. Role of dietary phosphate restriction in chronic kidney disease. Nephrology (Carlton). 2018 Dec;23(12):1107-1115. doi: 10.1111/nep.13188.

  PMID: 29064141 RESULT

• 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.

  PMID: 19539185 RESULT

• 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.

  PMID: 27528215 RESULT

MeSH Terms

Conditions

Hyperphosphatemia

Condition Hierarchy (Ancestors)

Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Tilakavati Karupaiah, PhD

  Taylor's University

  PRINCIPAL INVESTIGATOR

• Teong Lee Fang, BSc

  Taylor's University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: SRI Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 10, 2021
• Study Start: November 1, 2019
• Primary Completion: February 29, 2020
• Study Completion: February 29, 2020
• Last Updated: March 10, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

MY (3)