DDEP for Lifestyle Modification in Chronic Kidney Disease

A Randomized Controlled Feasibility Trial Evaluating the Implementation of Digital Dyadic Empowerment Program (DDEP) on Lifestyle Modification for Chronic Kidney Disease Management

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

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Diseases
• Intervention / Treatment: Behavioral: Digital Dyadic Empowerment

Detailed Description

The trial will be conducted on 60 dyads, each comprising a CKD patient and a significant other, who will be randomly assigned into two groups. The intervention group will receive the Digital Dyadic Empowerment Program (DDEP) while the control group will receive routine education and care.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Tainan City, Taiwan, 70101
    • National Cheng Kung University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digital Dyadic Empowerment; 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; 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: Access to CKD Health Education Information;; Supportive Information for Significant Others;; Physiological Values Logging for Self-Monitoring;; Reminders for Clinical Appointments and Daily Self-Management Tasks;; Kidney Health Diary for Lifestyle Modification Progress Tracking;; 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.; Other Names: LINE Official Account - Kidney Lifestyle
No Intervention: Control group; The control group receives routine education and care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Adherence to Health Behaviors at 3 Months (Patient-specific)	For each patient, change from Baseline (Followup score - Baseline score) in patient's adherence to healthy behaviors was measured using the Adherence to Healthy Behaviors Scale (AHBS). The scale includes 13 items rated on a 5-point Likert scale, with total scores ranging from 0 to 52. Higher scores indicate better adherence.	Before initial intervention and 3 months after initial intervention
Change From Baseline in Helping Relationships From Significant Others at 3 Months (Patient-specific)	For each patient, change from Baseline (Followup score - Baseline score) in patient's Helping Relationships from Significant Others at 3 months was assessed using the Chinese version of the Helping Relationships from Significant Others Scale (HRSO).The scale consists of 15 items rated on a 7-point Likert scale, with total scores ranging from 15 to 105. Higher scores indicate better support from the significant other.	Before initial intervention and 3 months after initial intervention
Change From Baseline in Dyadic Adjustment at 3 Months	For each participant, change from Baseline (Followup score - Baseline score) in Dyadic Adjustment at 3 months was assessed using the 7-item Dyadic Adjustment Scale (DAS-7). The first six items are rated on a 6-point scale, while the seventh item is rated on a 7-point scale. The total scores range from 0 to 36, with higher scores indicating better relationship quality.	Before initial intervention and 3 months after initial intervention

Collaborators and Investigators

• Sponsor: National Cheng Kung University
• Collaborators: National Health Research Institutes, Taiwan
• Investigators: Principal Investigator: Miaofen Yen, PhD, National Cheng Kung University

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2024
• Primary Completion (Actual): November 8, 2024
• Study Completion (Actual): December 2, 2024

Study Registration Dates

• First Submitted: January 18, 2024
• First Submitted That Met QC Criteria: January 18, 2024
• First Posted (Actual): January 26, 2024

Study Record Updates

• Last Update Posted (Actual): May 2, 2025
• Last Update Submitted That Met QC Criteria: April 25, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: healthy lifestyle; digital health; feasibility studies
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: NHRI-EX113-11106PI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No