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HyperphosphatemiaNCT04789876

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

A study testing Phosphate mobile app and One-off dietary counselling with a phosphate booklet in people with Hyperphosphatemia and End Stage Renal Disease on Dialysis, run by Taylor's University at 3 sites in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Phosphate mobile app and One-off dietary counselling with a phosphate booklet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
3 sitesMalaysia
Study dates
1 Nov 2019to 29 Feb 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 15Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country.

Malaysia3 sites

  • Pusat Rawatan Dialisis Islah

    Batu Caves, Selangor, 68100

  • Hospital Kuala Lumpur

    Kuala Lumpur, 50586

  • National Kidney Foundation Malaysia

    Petaling Jaya, Selangor, 46100

Other trials in Malaysia

About this study

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

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.

Read the 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.

Being tested
Phosphate mobile app, One-off dietary counselling with a phosphate booklet
Keywords
Hemodialysis, Hyperphosphatemia, Mobile app, Dietary counseling, Serum phosphorus, Phosphate knowledge, Dietary intake, Phosphate binder adherence
Medical subject headings
Hyperphosphatemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Phosphate mobile appOther

    Also called MyKidneyDiet - Phosphate Tracker

    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 bookletBehavioural

    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.

Study groups in NCT04789876
Study groupRoleWhat they receive
App Intervention Group (AIG)ExperimentalPhosphate mobile app for 12 weeks.
Receives: Other: Phosphate mobile app
Dietitian Intervention Group (DIG)Active comparatorOne-off 45-minute dietary counselling delivered by a dietitian at the baseline of the study.
Receives: Behavioral: One-off dietary counselling with a phosphate booklet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in serum phosphorus

    Effect of intervention on serum phosphorus

    Measured: Baseline, 12 weeks

Secondary outcomes (3)

  1. 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.

    Measured: Baseline, 12 weeks

  2. 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.

    Measured: Baseline, 12 weeks

  3. 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.

    Measured: Baseline, 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2021
  2. Study start1 Nov 2019
  3. Primary completion29 Feb 2020
  4. Study completion29 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04789876
Sponsor's protocol ID
HEC 2019/011
Other IDs
NMRR-19-3825-45381
Status last verified
Mar 2021
First submitted
2 Mar 2021
Last updated
10 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29459980

  • 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.

    PubMed 30013329

  • 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.

    PubMed 31302884

  • 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.

    PubMed 28398983

  • 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.

    PubMed 32706698

  • 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.

    PubMed 29064141

  • 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.

    PubMed 19539185

  • 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.

    PubMed 27528215

Questions about this trial

What is this clinical trial studying?

A study testing Phosphate mobile app and One-off dietary counselling with a phosphate booklet in people with Hyperphosphatemia and End Stage Renal Disease on Dialysis, run by Taylor's University at 3 sites in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in serum phosphorus (time frame: Baseline, 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04789876, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.

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