Clinical trial NCT06756113: Digital Dyadic Empowerment Program on Lifestyle Modification for Chronic Kidney Disease Management
Official title: Digital Dyadic Empowerment Program (DDEP) on Lifestyle Modification for Chronic Kidney Disease Management: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Kidney Diseases
Keywords: digital health
dyadic empowerment
healthy lifestyle
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
Collaborators: name: National Health Research Institutes, Taiwan
First posted: 2025-01-01
Enrollment: 208
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. The patient has a diagnosis of Chronic Kidney Disease for at least six months;
2. The patient can identify a helpful significant other, and both parties are willing to participate;
3. The patient can communicate in Mandarin or Taiwanese.

Exclusion Criteria:

1. The significant other is a healthcare provider;
2. The patient or the significant other has a mental illness diagnosis;
3. The patient is currently receiving renal replacement therapies;
4. Neither the patient nor the significant other uses a smartphone or the LINE messaging app.

Primary outcomes:
measure: Change from Baseline in eGFR at 6 Months (Patient-specific)
timeFrame: Before initial intervention and 6 months after initial intervention
Secondary outcomes:
measure: Change from Baseline in CKD Stage at 6 Months (Patient-specific)
timeFrame: Before initial intervention and 6 months after initial intervention
measure: Change from Baseline in TTM Stage at 6 Months (Patient-specific)
timeFrame: Before initial intervention and 6 months after initial intervention
measure: Change from Baseline in Health Promoting Lifestyle at 6 Months (Patient-specific)
timeFrame: Before initial intervention and 6 months after initial intervention
measure: Change from Baseline in Dyadic Adjustment at 6 Months
timeFrame: Before initial intervention and 6 months after initial intervention
Other outcomes:
Locations:
city: Tainan City
country: Taiwan
facility: National Cheng Kung University
Study officials:
affiliation: National Cheng Kung University
name: Miaofen Yen, PhD
role: PRINCIPAL_INVESTIGATOR
References: