Effectiveness of The Phosphate Mobile App on Serum Phosphorus in Adult Hemodialysis Patients With Hyperphosphatemia
NCT ID: NCT04789876
Last Updated: 2021-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
74 participants
INTERVENTIONAL
2019-11-01
2020-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy of Dietary Education and Education on Phosphate Binder Use in Hemodialysis Patients
NCT02755961
Dietary Phosphorus Load and Postprandial Serum Phosphate in HD Patients
NCT04845724
Individualized Treatment of Hyperphosphatemia in Maintenance Hemodialysis Patients
NCT03861247
The Efficacy of Niacin on Hyperphosphatemia in Patients Undergoing Haemodialysis
NCT03163576
A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China
NCT06933472
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
App Intervention Group (AIG)
Phosphate mobile app for 12 weeks.
Phosphate mobile app
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.
Dietitian Intervention Group (DIG)
One-off 45-minute dietary counselling delivered by a dietitian at the baseline of the study.
One-off dietary counselling with a phosphate booklet
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Phosphate mobile app
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.
One-off dietary counselling with a phosphate booklet
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Taylor's University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Tilakavati Karupaiah
SRI Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tilakavati Karupaiah, PhD
Role: PRINCIPAL_INVESTIGATOR
Taylor's University
Teong Lee Fang, BSc
Role: STUDY_CHAIR
Taylor's University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Pusat Rawatan Dialisis Islah
Batu Caves, Selangor, Malaysia
National Kidney Foundation Malaysia
Petaling Jaya, Selangor, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, , Malaysia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NMRR-19-3825-45381
Identifier Type: REGISTRY
Identifier Source: secondary_id
HEC 2019/011
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.