A Randomized Controlled Feasibility Trial Evaluating the Implementation of Digital Dyadic Empowerment Program (DDEP) on Lifestyle Modification for Chronic Kidney Disease Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change From Baseline in eGFR at 3 Months (Patient-specific)
研究概览
简要总结
This is a randomized controlled feasibility trial conducted on patients with Chronic Kidney Disease (CKD) and their significant other
详细描述
The trial will be conducted on 60 dyads, each comprising a CKD patient and a significant other, who will be randomly assigned into two groups. The intervention group will receive the Digital Dyadic Empowerment Program (DDEP) while the control group will receive routine education and care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has a diagnosis of Chronic Kidney Disease for at least six months;
- •The patient can identify a helpful significant other and both parties are willing to participate;
- •The patient can communicate in Mandarin or Taiwanese.
排除标准
- •The significant other is a healthcare provider;
- •The patient or the significant other has a mental illness diagnosis;
- •The patient is currently receiving renal replacement therapies.
结局指标
主要结局
Change From Baseline in eGFR at 3 Months (Patient-specific)
时间窗: Before initial intervention and 3 months after initial intervention
For each patient, change from Baseline (Followup score - Baseline score) in the estimated Glomerular Filtration Rate (eGFR) by the IDMS-MDRD Equation at 3 months was obtained through the patient's biochemical test reports. Higher eGFR numbers generally indicate better kidney functions.
Change From Baseline in CKD Stage at 3 Months (Patient-specific)
时间窗: Before initial intervention and 3 months after initial intervention
For each patient, the change from Baseline in CKD stage at 3 months was obtained by comparing the CKD stage at baseline and at follow-up, converted into the following three categories: (1) recover (e.g., from Stage 3a \[at baseline\] to Stage 2 \[at follow-up\]); (2) stable (e.g., remaining Stage 3a at both baseline and follow-up); and (3) progress (e.g., from Stage 3a \[at baseline\] to Stage 3b \[at follow-up\]).
Change From Baseline in TTM Stage at 3 Months
时间窗: Before initial intervention and 3 months after initial intervention
For each dyad, change from Baseline in TTM stage at 3 months was obtained by comparing the TTM stage of change at baseline and at follow-up, converted into the following three categories: (1) regress (e.g., from Preparation \[at baseline\] to Contemplation \[at follow-up\]); (2) maintain (e.g., remaining Action at both baseline and follow-up); and (3) advance (e.g., from Action \[at baseline\] to Maintanece \[at follow-up\]).
Change From Baseline in Health Promoting Lifestyle at 3 Months (Patient-specific)
时间窗: Before initial intervention and 3 months after initial intervention
For each patient, change from Baseline (Followup score - Baseline score) in patient's Health Promoting Lifestyle at 3 months was assessed using the Chinese version of the Health Promoting Lifestyle Profile-II (HPLP-II), a validated scale with 52 items rated on a 4-point Likert scale. The total scores range from 52 to 208, with higher scores indicate better health-promoting behavior.
Change From Baseline in Quality of Life at 3 Months
时间窗: Before initial intervention and 3 months after initial intervention
For each participant, change from Baseline (Followup score - Baseline score) in Quality of Life at 3 months was assessed using the first item of the Taiwanese version of the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF). The item was rated on a 5-point Likert scale, ranging from 1 to 5. Higher scores indicate better quality of life.
次要结局
- Change From Baseline in Adherence to Health Behaviors at 3 Months (Patient-specific)(Before initial intervention and 3 months after initial intervention)
- Change From Baseline in Helping Relationships From Significant Others at 3 Months (Patient-specific)(Before initial intervention and 3 months after initial intervention)
- Change From Baseline in Dyadic Adjustment at 3 Months(Before initial intervention and 3 months after initial intervention)
研究者
Miaofen Yen
Professor, Department of Nursing, College of Medicine
National Cheng Kung University