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

March 8, 2021 updated by: Tilakavati Karupaiah, Taylor's University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
      • Kuala Lumpur, Malaysia, 50586
        • Hospital Kuala Lumpur
    • Selangor
      • Batu Caves, Selangor, Malaysia, 68100
        • Pusat Rawatan Dialisis Islah
      • Petaling Jaya, Selangor, Malaysia, 46100
        • National Kidney Foundation Malaysia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: App Intervention Group (AIG)
Phosphate mobile app for 12 weeks.
Other: 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.
Other Names:
  • MyKidneyDiet - Phosphate Tracker
Active Comparator: Dietitian Intervention Group (DIG)
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in serum phosphorus
Time Frame: Baseline, 12 weeks
Effect of intervention on serum phosphorus
Baseline, 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in phosphate knowledge
Time Frame: Baseline, 12 weeks
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
Changes in dietary intake
Time Frame: Baseline, 12 weeks
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
Changes in phosphate binder adherence
Time Frame: Baseline, 12 weeks
Phosphate binder adherence measured using the 4-item Morisky Medication Adherence Scale (MMAS) at baseline and 12-week after the intervention.
Baseline, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taylor's University

Investigators

  • Study Chair: Teong Lee Fang, BSc, Taylor's University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2019

Primary Completion (Actual)

February 29, 2020

Study Completion (Actual)

February 29, 2020

Study Registration Dates

First Submitted

March 2, 2021

First Submitted That Met QC Criteria

March 8, 2021

First Posted (Actual)

March 10, 2021

Study Record Updates

Last Update Posted (Actual)

March 10, 2021

Last Update Submitted That Met QC Criteria

March 8, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEC 2019/011
  • NMRR-19-3825-45381 (Registry Identifier: National Medical Research Register)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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