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临床试验/NCT06065501
NCT06065501已完成不适用

Frailty Trajectories and Effects of Personalized Actionable Connected Extensible (PACE) Interventions Among Patients With Chronic Kidney Disease: A Longitudinal Study

National Cheng Kung University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年10月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Tilburg Frailty Indicator (TFI)

研究概览

简要总结

This is a randomized controlled trial study conducted on frail patients with chronic kidney disease(CKD).

详细描述

The study will be conducted on 120 frail patients with CKD, who will be divided into 2 groups: Group 1, consisting of 60 frail patients, will receive PACE intervention (based on mobile social network support) for 6 months. Group 2, comprising 60 frail patients, will receive usual CKD education and consultation for 6 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with CKD stage 1 to 5
  • Participants with pre-frail and frail conditions.
  • Having access to a mobile phone and is capable of using mobile social network application (Line)

排除标准

  • Received renal replacement therapy
  • Participants achieved TTM stage 5

研究组 & 干预措施

Control group

Active Comparator

The control group receives usual care, which involves standard CKD education and consultation.

干预措施: Usual care (Behavioral)

PACE intervention

Experimental

The intervention group (PACE intervention) utilizes mobile social network support, employing a LINE group to implement a personalized plan based on the TTM model for establishing a care program.

干预措施: PACE intervention (Behavioral)

结局指标

主要结局

Tilburg Frailty Indicator (TFI)

时间窗: Baseline, 3 months, and 6 months post-intervention

Frailty was measured using the Tilburg Frailty Indicator (TFI), a 15-item self-reported questionnaire assessing physical, psychological, and social domains. Total score ranges from 0 to 15, with higher scores indicating greater frailty.

次要结局

  • Physical Activity Level Measured by IPAQ-Taiwan(Baseline, 3 months, and 6 months post-intervention)
  • Health-promoting Lifestyle Behaviors (HPLP-II, Taiwan Version)(Baseline, 3 months, and 6 months post-intervention)
  • Nutritional Status Measured by MNA-SF(Baseline, 3 months, and 6 months post-intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Miaofen Yen

Professor, Department of Nursing College of Medicine, National Cheng Kung University

National Cheng Kung University

研究点 (1)

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