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

Sponsor
Taylor's University (Other)
Overall Status
Completed
CT.gov ID
NCT04789876
Collaborator
(none)
74
3
2
3.9
24.7
6.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Phosphate mobile app
  • Behavioral: One-off dietary counselling with a phosphate booklet
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
74 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Nov 1, 2019
Actual Primary Completion Date :
Feb 29, 2020
Actual Study Completion Date :
Feb 29, 2020

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Changes in serum phosphorus [Baseline, 12 weeks]

      Effect of intervention on serum phosphorus

    Secondary Outcome Measures

    1. Changes in phosphate knowledge [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.

    2. Changes in dietary intake [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.

    3. Changes in phosphate binder adherence [Baseline, 12 weeks]

      Phosphate binder adherence measured using the 4-item Morisky Medication Adherence Scale (MMAS) at baseline and 12-week after the intervention.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pusat Rawatan Dialisis Islah Batu Caves Selangor Malaysia 68100
    2 National Kidney Foundation Malaysia Petaling Jaya Selangor Malaysia 46100
    3 Hospital Kuala Lumpur Kuala Lumpur Malaysia 50586

    Sponsors and Collaborators

    • Taylor's University

    Investigators

    • Principal Investigator: Tilakavati Karupaiah, PhD, Taylor's University
    • Study Chair: Teong Lee Fang, BSc, Taylor's University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Tilakavati Karupaiah, SRI Professor, Taylor's University
    ClinicalTrials.gov Identifier:
    NCT04789876
    Other Study ID Numbers:
    • HEC 2019/011
    • NMRR-19-3825-45381
    First Posted:
    Mar 10, 2021
    Last Update Posted:
    Mar 10, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Tilakavati Karupaiah, SRI Professor, Taylor's University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 10, 2021