Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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
Hyperphosphatemia End Stage Renal Disease on Dialysis Other: Phosphate mobile app Behavioral: One-off dietary counselling with a phosphate booklet Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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.
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 : November 1, 2019
Actual Primary Completion Date : February 29, 2020
Actual Study Completion Date : February 29, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

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 Name: 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.




Primary Outcome Measures :
  1. Changes in serum phosphorus [ Time Frame: Baseline, 12 weeks ]
    Effect of intervention on serum phosphorus


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04789876


Locations
Layout table for location information
Malaysia
Pusat Rawatan Dialisis Islah
Batu Caves, Selangor, Malaysia, 68100
National Kidney Foundation Malaysia
Petaling Jaya, Selangor, Malaysia, 46100
Hospital Kuala Lumpur
Kuala Lumpur, Malaysia, 50586
Sponsors and Collaborators
Taylor's University
Investigators
Layout table for investigator information
Principal Investigator: Tilakavati Karupaiah, PhD Taylor's University
Study Chair: Teong Lee Fang, BSc Taylor's University
Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: Tilakavati Karupaiah, SRI Professor, Taylor's University
ClinicalTrials.gov Identifier: NCT04789876    
Other Study ID Numbers: HEC 2019/011
NMRR-19-3825-45381 ( Registry Identifier: National Medical Research Register )
First Posted: March 10, 2021    Key Record Dates
Last Update Posted: March 10, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tilakavati Karupaiah, Taylor's University:
Hemodialysis
Hyperphosphatemia
Mobile app
Dietary counseling
Serum phosphorus
Phosphate knowledge
Dietary intake
Phosphate binder adherence
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Failure, Chronic
Hyperphosphatemia
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Phosphorus Metabolism Disorders
Metabolic Diseases