Hyperphosphatemia Clinical Trial
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
Verified date | March 2021 |
Source | Taylor's University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 74 |
Est. completion date | February 29, 2020 |
Est. primary completion date | February 29, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Malaysia | Pusat Rawatan Dialisis Islah | Batu Caves | Selangor |
Malaysia | Hospital Kuala Lumpur | Kuala Lumpur | |
Malaysia | National Kidney Foundation Malaysia | Petaling Jaya | Selangor |
Lead Sponsor | Collaborator |
---|---|
Taylor's University |
Malaysia,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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/ — View 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. — View Citation
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. Review. — View 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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in serum phosphorus | Effect of intervention on serum phosphorus | Baseline, 12 weeks | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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