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

Primary Purpose

Hyperphosphatemia, End Stage Renal Disease on Dialysis

Status

Completed

Phase

Not Applicable

Locations

Malaysia

Study Type

Interventional

Intervention

Phosphate mobile app

One-off dietary counselling with a phosphate booklet

About this trial

This is an interventional treatment trial for Hyperphosphatemia focused on measuring Hemodialysis, Hyperphosphatemia, Mobile app, Dietary counseling, Serum phosphorus, Phosphate knowledge, Dietary intake, Phosphate binder adherence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Pusat Rawatan Dialisis Islah
National Kidney Foundation Malaysia
Hospital Kuala Lumpur

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

App Intervention Group (AIG)

Dietitian Intervention Group (DIG)

Arm Description

Phosphate mobile app for 12 weeks.

One-off 45-minute dietary counselling delivered by a dietitian at the baseline of the study.

Outcomes

Primary Outcome Measures

Changes in serum phosphorus

Effect of intervention on serum phosphorus

Secondary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT04789876

First Posted

March 2, 2021

Last Updated

March 8, 2021

Sponsor

Taylor's University

1. Study Identification

Unique Protocol Identification Number

NCT04789876

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

November 1, 2019 (Actual)

Primary Completion Date

February 29, 2020 (Actual)

Study Completion Date

February 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Taylor's University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperphosphatemia, End Stage Renal Disease on Dialysis

Keywords

Hemodialysis, Hyperphosphatemia, Mobile app, Dietary counseling, Serum phosphorus, Phosphate knowledge, Dietary intake, Phosphate binder adherence

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Randomized

Enrollment

74 (Actual)

8. Arms, Groups, and Interventions

Arm Title

App Intervention Group (AIG)

Arm Type

Experimental

Arm Description

Phosphate mobile app for 12 weeks.

Arm Title

Dietitian Intervention Group (DIG)

Arm Type

Active Comparator

Arm Description

One-off 45-minute dietary counselling delivered by a dietitian at the baseline of the study.

Intervention Type

Other

Intervention Name(s)

Phosphate mobile app

Other Intervention Name(s)

MyKidneyDiet - Phosphate Tracker

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

One-off dietary counselling with a phosphate booklet

Intervention Description

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 Measure Information:

Title

Changes in serum phosphorus

Description

Effect of intervention on serum phosphorus

Time Frame

Baseline, 12 weeks

Secondary Outcome Measure Information:

Title

Changes in phosphate knowledge

Description

Time Frame

Baseline, 12 weeks

Title

Changes in dietary intake

Description

Time Frame

Baseline, 12 weeks

Title

Changes in phosphate binder adherence

Description

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

Time Frame

Baseline, 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tilakavati Karupaiah, PhD

Organizational Affiliation

Taylor's University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Teong Lee Fang, BSc

Organizational Affiliation

Taylor's University

Official's Role

Study Chair

Facility Information:

Facility Name

Pusat Rawatan Dialisis Islah

City

Batu Caves

State/Province

Selangor

ZIP/Postal Code

68100

Country

Malaysia

Facility Name

National Kidney Foundation Malaysia

City

Petaling Jaya

State/Province

Selangor

ZIP/Postal Code

46100

Country

Malaysia

Facility Name

Hospital Kuala Lumpur

City

Kuala Lumpur

ZIP/Postal Code

50586

Country

Malaysia

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29459980

Citation

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.

Results Reference

background

PubMed Identifier

30013329

Citation

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.

Results Reference

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PubMed Identifier

31302884

Citation

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.

Results Reference

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PubMed Identifier

28398983

Citation

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Results Reference

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PubMed Identifier

32706698

Citation

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.

Results Reference

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PubMed Identifier

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Citation

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.

Results Reference

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PubMed Identifier

19539185

Citation

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.

Results Reference

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Citation

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Results Reference

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

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