DDEP for Lifestyle Modification in Chronic Kidney Disease

NCT06226649 | Completed Results

• 1 other identifier: NHRI-EX113-11106PI
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized controlled feasibility trial conducted on patients with Chronic Kidney Disease (CKD) and their significant other

Conditions

Chronic Kidney Diseases

Keywords

feasibility studies; digital health; healthy lifestyle

Outcome Measures

Primary Outcomes (5)

• Change From Baseline in eGFR at 3 Months (Patient-specific)

  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.

  Before initial intervention and 3 months after initial intervention

• Change From Baseline in CKD Stage at 3 Months (Patient-specific)

  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 \[at follow-up\]).

  Before initial intervention and 3 months after initial intervention

• Change From Baseline in TTM Stage at 3 Months

  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 \[at follow-up\]).

  Before initial intervention and 3 months after initial intervention

• Change From Baseline in Health Promoting Lifestyle at 3 Months (Patient-specific)

  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.

  Before initial intervention and 3 months after initial intervention

• Change From Baseline in Quality of Life at 3 Months

  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.

  Before initial intervention and 3 months after initial intervention

Secondary Outcomes (3)

• 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

Study Arms (2)

Digital Dyadic Empowerment

EXPERIMENTAL

The intervention group (Digital Dyadic Empowerment) will utilize LINE, a prominent instant messaging App in Taiwan, to assist in lifestyle modification, along with support from the significant other.

Behavioral: Digital Dyadic Empowerment

Control group

NO INTERVENTION

The control group receives routine education and 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

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.

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

Since this is a feasibility trial, the change from baseline estimates for all outcomes were underpowered, and therefore 95% confidence intervals (CIs) were reported instead.

Results Point of Contact

• Title: Mr. Chun-Yi Ho
• Organization: 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: January 18, 2024
• First Posted: January 26, 2024
• Study Start: January 29, 2024
• Primary Completion: November 8, 2024
• Study Completion: December 2, 2024
• Last Updated: May 2, 2025
• Results First Posted: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)