Skip to main content
OpenTrials
Completed

NCT Number: NCT06226649

DDEP for Lifestyle Modification in Chronic Kidney Disease

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

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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:

  • 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

Primary outcomes

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

    Time frame: Before initial intervention and 3 months after initial intervention

    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.

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

    Time frame: Before initial intervention and 3 months after initial intervention

    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]).

  3. Change From Baseline in TTM Stage at 3 Months

    Time frame: Before initial intervention and 3 months after initial intervention

    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]).

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

    Time frame: Before initial intervention and 3 months after initial intervention

    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.

  5. Change From Baseline in Quality of Life at 3 Months

    Time frame: Before initial intervention and 3 months after initial intervention

    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.

Secondary outcomes

  1. Change From Baseline in Adherence to Health Behaviors at 3 Months (Patient-specific)

    Time frame: Before initial intervention and 3 months after initial intervention

    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.

  2. Change From Baseline in Helping Relationships From Significant Others at 3 Months (Patient-specific)

    Time frame: Before initial intervention and 3 months after initial intervention

    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.

  3. Change From Baseline in Dyadic Adjustment at 3 Months

    Time frame: Before initial intervention and 3 months after initial intervention

    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.

Sponsors and collaborators

Lead sponsor

National Cheng Kung University

Other

Collaborators

  • National Health Research Institutes, Taiwan

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 26, 2024
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.