Digital Dyadic Empowerment Program on Lifestyle Modification for Chronic Kidney Disease Management

NCT ID: NCT06756113

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-13
• Study Completion Date: 2025-12-31

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.

Conditions

Chronic Kidney Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Digital Dyadic Empowerment

Intervention Type: BEHAVIORAL

The Digital Dyadic Empowerment Intervention utilizes LINE, a prominent instant messaging App in Taiwan, integrated with an extended application to deliver comprehensive lifestyle modification support to Chronic Kidney Disease (CKD) dyads. Key features of this intervention include:

1. Access to CKD Health Education Information;

2. Supportive Information for Significant Others;

3. Physiological Values Logging for Self-Monitoring;

4. Reminders for Clinical Appointments and Daily Self-Management Tasks;

5. Kidney Health Diary for Lifestyle Modification Progress Tracking;

6. Frequently Asked Questions (FAQs) and Consultation with Healthcare Providers.

This intervention aims to enhance the overall well-being of CKD dyads by promoting education, self-monitoring, adherence to appointments, and efficient communication with healthcare providers.

Usual Care

Intervention Type: BEHAVIORAL

All patients in this study received regular nephrology care at National Cheng Kung University Hospital. Nephrologists conducted routine examinations and provided diagnoses based on test results. The patient's condition (e.g., changes in kidney function), treatment plan, prognosis, and risks were explained to both the patient and family members. The treatment plan included medication, monitoring blood pressure, dietary and exercise at home, and consultations with the Health Education Center for kidney care or nutrition advice.

Usual Care

The control group will receive usual care only.

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: BEHAVIORAL

All patients in this study received regular nephrology care at National Cheng Kung University Hospital. Nephrologists conducted routine examinations and provided diagnoses based on test results. The patient's condition (e.g., changes in kidney function), treatment plan, prognosis, and risks were explained to both the patient and family members. The treatment plan included medication, monitoring blood pressure, dietary and exercise at home, and consultations with the Health Education Center for kidney care or nutrition advice.

Interventions

Digital Dyadic Empowerment

The Digital Dyadic Empowerment Intervention utilizes LINE, a prominent instant messaging App in Taiwan, integrated with an extended application to deliver comprehensive lifestyle modification support to Chronic Kidney Disease (CKD) dyads. Key features of this intervention include:

1. Access to CKD Health Education Information;

2. Supportive Information for Significant Others;

3. Physiological Values Logging for Self-Monitoring;

4. Reminders for Clinical Appointments and Daily Self-Management Tasks;

5. Kidney Health Diary for Lifestyle Modification Progress Tracking;

6. Frequently Asked Questions (FAQs) and Consultation with Healthcare Providers.

This intervention aims to enhance the overall well-being of CKD dyads by promoting education, self-monitoring, adherence to appointments, and efficient communication with healthcare providers.

Intervention Type: BEHAVIORAL

Usual Care

All patients in this study received regular nephrology care at National Cheng Kung University Hospital. Nephrologists conducted routine examinations and provided diagnoses based on test results. The patient's condition (e.g., changes in kidney function), treatment plan, prognosis, and risks were explained to both the patient and family members. The treatment plan included medication, monitoring blood pressure, dietary and exercise at home, and consultations with the Health Education Center for kidney care or nutrition advice.

Intervention Type: BEHAVIORAL

Other Intervention Names

LINE Official Account - Kidney Lifestyle

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Health Research Institutes, Taiwan

OTHER

Sponsor Role: collaborator

National Cheng Kung University

OTHER

Sponsor Role: lead

Responsible Party

Miaofen Yen

Professor, Department of Nursing, College of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Miaofen Yen, PhD

Role: PRINCIPAL_INVESTIGATOR

National Cheng Kung University

Locations

National Cheng Kung University

Tainan City, , Taiwan

Countries

Taiwan

Other Identifiers

NHRI-EX114-11106PI

Identifier Type: -

Identifier Source: org_study_id