A Randomized Controlled Feasibility Trial Evaluating the Implementation of Digital Dyadic Empowerment Program (DDEP) on Lifestyle Modification for Chronic Kidney Disease Management
Phase: NA
Conditions: Chronic Kidney Diseases
Sponsor: National Cheng Kung University

Digital Dyadic Empowerment Program on Lifestyle 
Modification for Chronic Kidney Disease Management
Study Protocol
Official Title for Year 3 Feasibility Study:
A randomized controlled feasibility trial evaluating the 
Implementation of Digital Dyadic Empowerment Program 
(DDEP) on Lifestyle Modification for Chronic Kidney Disease 
Management
ID: NHRI-EX113-11106PI
NCT06226649
Responsible Party: 
Principal Investigator: Miaofen Yen [MYen]
Official Title: Professor, Department of Nursing, 
College of Medicine
Affiliation: National Cheng Kung University
Collaborators: 
National Health Research Institutes, Taiwan
Document Date: December 4th, 2023

DDEP RANDOMIZED FEASIBILITY TRIAL 
 
1 
A Randomized Controlled Feasibility Trial Evaluating the Implementation of Digital 
Dyadic Empowerment Program (DDEP) on Lifestyle Modification for Chronic Kidney 
Disease Management 
Objective 
This study aims to conduct a feasibility trial to explore the experiences and engagement of 
patient-significant other dyads in the implementation of the Digital Dyadic Empowerment 
Program (DDEP) for chronic kidney disease (CKD) management. 
Design 
A feasibility study will employ a randomized controlled trial (RCT) design, adhering to the 
Clinical Practice and Consolidated Standards of Reporting Trials (CONSORT) guidelines 
(Eldridge et al., 2016). 
Participants 
Participants will include CKD patients aged 20 years and older (stage 1–5 CKD, minimum 
six months) and their identified significant others. Inclusion criteria are: 
1. Patients can identify a supportive significant other, and both are willing to participate. 
2. Patients can communicate in Mandarin or Taiwanese. 
Exclusion criteria: 
1. Significant other is a healthcare provider. 
2. Either participant has a known mental illness. 
3. Patients are receiving renal replacement therapies. 

DDEP RANDOMIZED FEASIBILITY TRIAL                  
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Setting 
The study will be conducted in nephrology outpatient clinics at a medical center in Southern 
Taiwan. 
Sample Size 
Sixty dyads will be recruited. This number, in line with feasibility study guidelines (Hertzog, 
2008; Leon et al., 2011), will allow determination of feasibility and provide effect size 
estimates for a future definitive trial. 
Measurements 
Data will be collected using validated instruments, including: 
• 
Demographics and Disease-Related Characteristics. 
• 
Transtheoretical Model (TTM) Staging Inventory. 
• 
Dyadic Adjustment Scale (DAS). 
• 
Adherence to Health Behaviors Scale (AHBS). 
• 
Helping Relationships with Significant Others (HRSO). 
• 
Health Promotion Lifestyle Profile-II (Chinese version, short form). 
• 
WHO Quality of Life Questionnaire (WHOQOL-BREF). 
Procedure 
Eligible patients will be referred by case managers during routine clinic visits. Dyads who 
provide informed consent will be randomly assigned (via a paper-ballot method) to the 
experimental group (DDEP) or control group (routine care). Baseline data will be collected, 
including relationship quality (DAS), quality of life (WHOQOL-BREF), and patient-specific 
measures (AHBS, HRSO, Health Promotion Lifestyle Profile-II). Data collection will occur 
in private rooms and require approximately 50 minutes. 

DDEP RANDOMIZED FEASIBILITY TRIAL                  
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The intervention group will receive the DDEP, while the control group will receive routine 
education and care. Baseline and post-intervention stages of change and outcomes will be 
evaluated. Participants will receive a small gift after each data collection period. 
Data Analysis 
Feasibility metrics will include recruitment rates, attrition, and acceptability of interventions. 
These will be reported using CONSORT guidelines. An intention-to-treat analysis will 
address attrition to ensure unbiased group comparisons. Baseline characteristics will be 
statistically analyzed for group differences, and descriptive results will be presented as 
summary statistics. 
This feasibility study will provide valuable insights into the acceptability of trial design, 
interventions, and measurement tools, supporting the development of a definitive RCT in the 
future. 
 
 
 
 

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References 
Eldridge, S. M., Chan, C. L., Campbell, M. J., Bond, C. M., Hopewell, S., Thabane, L., 
 
Lancaster, G. A., & PAFS consensus group (2016). CONSORT 2010 statement: 
 
extension to randomised pilot and feasibility trials. BMJ (Clinical Research Ed.), 355, 
 
i5239. https://doi.org/10.1136/bmj.i5239 
Hertzog, M. A. (2008). Considerations in determining sample size for pilot studies. Research 
 
in Nursing & Health, 31(2), 180–191. https://doi.org/10.1002/nur.20247 
Leon, A. C., Davis, L. L., & Kraemer, H. C. (2011). The role and interpretation of pilot 
 
studies in clinical research. Journal of Psychiatric Research, 45(5), 626–629. 
 
https://doi.org/10.1016/j.jpsychires.2010.10.008