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

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ClinicalTrials.gov Identifier: NCT04789876
Recruitment Status : Completed
First Posted : March 10, 2021
Last Update Posted : March 10, 2021
Sponsor:
Information provided by (Responsible Party):
Tilakavati Karupaiah, Taylor's University

Tracking Information
First Submitted Date  ICMJE March 2, 2021
First Posted Date  ICMJE March 10, 2021
Last Update Posted Date March 10, 2021
Actual Study Start Date  ICMJE November 1, 2019
Actual Primary Completion Date February 29, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2021)
Changes in serum phosphorus [ Time Frame: Baseline, 12 weeks ]
Effect of intervention on serum phosphorus
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2021)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of The Phosphate Mobile App on Serum Phosphorus in Adult Hemodialysis Patients With Hyperphosphatemia
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hyperphosphatemia
  • End Stage Renal Disease on Dialysis
Intervention  ICMJE
  • 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 Name: MyKidneyDiet - Phosphate Tracker
  • 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.
Study Arms  ICMJE
  • Experimental: App Intervention Group (AIG)
    Phosphate mobile app for 12 weeks.
    Intervention: Other: Phosphate mobile app
  • Active Comparator: Dietitian Intervention Group (DIG)
    One-off 45-minute dietary counselling delivered by a dietitian at the baseline of the study.
    Intervention: Behavioral: One-off dietary counselling with a phosphate booklet
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 8, 2021)
74
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 29, 2020
Actual Primary Completion Date February 29, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Malaysia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04789876
Other Study ID Numbers  ICMJE HEC 2019/011
NMRR-19-3825-45381 ( Registry Identifier: National Medical Research Register )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Tilakavati Karupaiah, Taylor's University
Study Sponsor  ICMJE Taylor's University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tilakavati Karupaiah, PhD Taylor's University
Study Chair: Teong Lee Fang, BSc Taylor's University
PRS Account Taylor's University
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP