A pilot study to investigate the effectiveness of Digital health interventions on physical activity and quality of life among hemodialysis patients at AIIMS, New Delhi.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Daily step count and monthly step count.
研究概览
简要总结
Primary objective
1. To evaluate the effectiveness of digital health interventions (DHIs) on step count among MHD patients.
Secondary objectives
2. To evaluate the effectiveness of digital health interventions (DHIs) on the other measures of physical activity (STS-10, STS-60, 6 MWT and HGS) among MHD patients.
3. To evaluate the effectiveness of digital health interventions (DHIs) on quality of life among MHD patients.
4. To seek a relationship between physical activity, and quality of life among MHD patients.
Research Hypothesis:
H1: MHD patients will have improved step count after 12 months of DHI intervention than those getting standard care.
H2: MHD patients will have improved physical activity as measured by STS-6, STS-60 and hand grip after 12 months of digital health interventions than those getting standard care.
H3: MHD patients will have improved quality of life as measured by KDQOL after 12 months of digital health interventions than those getting standard care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •patients aged 18 years and above with a diagnosis of CKD on maintenance HD for more than 3 months.
- •willing to participate in the study.
排除标准
- •Patient: having inability to use a smartphone having functional impairment or have pain or discomfort while walking having any psychiatric disorder had any hospitalization during the previous 3 months.
- •change dialysis modality or undergo renal transplantation during the study period.
结局指标
主要结局
Daily step count and monthly step count.
时间窗: Baseline, and at 3, 6, 9, 12 months after initiation of the study.
次要结局
- Quality of life and other objective measures of physical activity (STS-10, STS-60, 6MWT and HGS).(baseline, and at 3, 6, 9, 12 months after initiation of the study.)
研究者
Dr Manju Amit Kumar Rajora
AIIMS New Delhi