Digital Dyadic Empowerment Program (DDEP) on Lifestyle Modification for Chronic Kidney Disease Management: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Change From Baseline in eGFR at 6 Months (Patient-specific)
研究概览
简要总结
The goal of this clinical trial is to find out if the Digital Dyadic Empowerment Program (DDEP) can help people with chronic kidney disease (CKD) and their care partners make healthy lifestyle changes. The main questions this study will answer are:
- Does DDEP help protect kidney function?
- Does DDEP support healthier daily habits?
Researchers will compare two groups:
- One group will receive the DDEP and get usual medical care.
- The other group will get usual medical care only.
Participants will:
- Receive usual care with or without DDEP for six months.
- Visit the clinic at the start and end of the study for health checks and tests.
- Practice healthy habits at home with or without help from DDEP.
This study aims to show if adding DDEP to regular care can make it easier for people with CKD and their care partners to live healthier lives.
详细描述
This randomized controlled trial (RCT) aims to evaluate the long-term effects of the Digital Dyadic Empowerment Program (DDEP) in comparison to routine care for people with chronic kidney disease (CKD) and their significant others. The study will assess whether the DDEP can improve health outcomes such as kidney function, health-promoting lifestyle behaviors, and the quality of relationships between significant others over a six-month period. The trial will follow the Consolidated Standards of Reporting Trials (CONSORT) 2010 and CONSORT-EHEALTH guidelines to ensure rigorous reporting and transparency.
Baseline assessments will occur in a private clinic room and will include demographic information, disease-related characteristics, and self-reported measures. Participants in both groups will also complete the Trans-Theoretical Model (TTM) staging inventory to evaluate their readiness for lifestyle changes. Dyads assigned to the intervention group will receive DDEP setup instructions and training on platform use during the baseline visit. Throughout the study, dyads will be encouraged to utilize the platform for self-management tasks at home, including diet tracking, exercise planning, and monitoring blood pressure.
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;
- •Neither the patient nor the significant other uses a smartphone or the LINE messaging app.
研究组 & 干预措施
Digital Dyadic Empowerment + Usual Care
The intervention group (Digital Dyadic Empowerment + Usual Care) will receive usual care and utilize LINE, a prominent instant messaging App in Taiwan, to assist in lifestyle modification at home along with support from the significant other.
干预措施: Digital Dyadic Empowerment (Behavioral)
Digital Dyadic Empowerment + Usual Care
The intervention group (Digital Dyadic Empowerment + Usual Care) will receive usual care and utilize LINE, a prominent instant messaging App in Taiwan, to assist in lifestyle modification at home along with support from the significant other.
干预措施: Usual Care (Behavioral)
Usual Care
The control group will receive usual care only.
干预措施: Usual Care (Behavioral)
结局指标
主要结局
Change From Baseline in eGFR at 6 Months (Patient-specific)
时间窗: Before initial intervention and 6 months after initial intervention
For each patient, change from Baseline (Followup score - Baseline score) in the estimated Glomerular Filtration Rate (eGFR) by the Isotope Dilution Mass Spectrometry - Modification of Diet in Renal Disease (IDMS-MDRD) Equation at 6 months was obtained through the patient's biochemical test reports. Higher eGFR numbers generally indicate better kidney functions.
次要结局
- Change From Baseline in CKD Stage at 6 Months (Patient-specific)(Before initial intervention and 6 months after initial intervention)
- Change From Baseline in TTM Stage at 6 Months (Patient-specific)(Before initial intervention and 6 months after initial intervention)
- Change From Baseline in Health Promoting Lifestyle at 6 Months (Patient-specific)(Before initial intervention and 6 months after initial intervention)
- Change From Baseline in Dyadic Adjustment at 6 Months(Before initial intervention and 6 months after initial intervention)
研究者
Miaofen Yen
Professor, Department of Nursing, College of Medicine
National Cheng Kung University