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

NCT06756113 | Completed Results

• 1 other identifier: NHRI-EX114-11106PI
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases

Keywords

digital health; dyadic empowerment; healthy lifestyle

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in eGFR at 6 Months (Patient-specific)

  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.

  Before initial intervention and 6 months after initial intervention

Secondary Outcomes (4)

• 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

Study Arms (2)

Digital Dyadic Empowerment + Usual Care

EXPERIMENTAL

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.

Behavioral: Digital Dyadic Empowerment; Behavioral: Usual Care

Usual Care

ACTIVE COMPARATOR

The control group will receive usual care only.

Behavioral: Usual Care

Interventions

Digital Dyadic Empowerment 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.

Also known as: LINE Official Account - Kidney Lifestyle

Digital Dyadic Empowerment + Usual Care

Usual Care 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.

Digital Dyadic Empowerment + Usual Care; Usual Care

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cheng Kung University: lead
• National Health Research Institutes, Taiwan: collaborator

Study Sites (1)

National Cheng Kung University

Tainan, 70101, Taiwan

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

1. Follow-up (6 months) may be too short to detect eGFR changes. 2. As a single-center trial, enrolling only dyads with smartphone/LINE access and an available significant other, generalizability is limited. 3. Usage (any log-in) may not capture behavior-change quality, and some questionnaires may be insensitive/misaligned. 4. Models did not adjust key prognostic factors (e.g., age, baseline CKD stage). 5. Platform issues and RA support needs warrant cautious interpretation of use-outcome links.

Results Point of Contact

• Title: Chun-Yi Ho, Research Assistant
• Organization: Department of Nursing, College of Medicine, National Cheng Kung University

eggman0011@gmail.com

886-6-2353535

Study Officials

• Miaofen Yen, PhD

  National Cheng Kung University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Nursing, College of Medicine

Study Record Dates

• First Submitted: December 24, 2024
• First Posted: January 1, 2025
• Study Start: January 13, 2025
• Primary Completion: October 8, 2025
• Study Completion: October 15, 2025
• Last Updated: February 12, 2026
• Results First Posted: February 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)