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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 6
- 主要终点
- Changes in serum phosphorus
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Changes in serum phosphorus
时间窗: Baseline, 12 weeks
Effect of intervention on serum phosphorus
次要结局
- Changes in phosphate knowledge(Baseline, 12 weeks)
- Changes in dietary intake(Baseline, 12 weeks)
- Changes in phosphate binder adherence(Baseline, 12 weeks)
研究者
Tilakavati Karupaiah
SRI Professor
Taylor's University