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
|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|
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 (Clinical Trial)|
|Actual Enrollment :||74 participants|
|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)|
|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|
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.
- Changes in serum phosphorus [ Time Frame: Baseline, 12 weeks ]Effect of intervention on serum phosphorus
- 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.
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
|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|
|Principal Investigator:||Tilakavati Karupaiah, PhD||Taylor's University|
|Study Chair:||Teong Lee Fang, BSc||Taylor's University|