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

 
Study Protocol 
Digital Dyadic Empowerment Program on Lifestyle 
Modification for Chronic Kidney Disease Management 
 
 
Official Title for Year 4 Study: 
Digital Dyadic Empowerment Program (DDEP) on Lifestyle Modification 
for Chronic Kidney Disease Management: A Randomized Controlled Trial 
 
 
ID: NHRI-EX114-11106PI 
NCT06756113 
 
 
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 13th, 2024 

DDEP RANDOMIZED CONTROLLED TRIAL                  
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Digital Dyadic Empowerment Program (DDEP) on Lifestyle Modification for Chronic 
Kidney Disease Management: A Randomized Controlled Trial 
Objective 
The purpose of this randomized controlled trial is to examine the synergistic long-term 
effects of the Digital Dyadic Empowerment Program (DDEP) compared to routine care 
among patients with chronic kidney disease (CKD). Specifically, the study aims to evaluate 
the program’s impact on patients’ kidney function, health-promoting lifestyle behaviors, and 
the dyads’ relationship quality over time. 
Design 
A randomized controlled trial (RCT) will be conducted to test the effect of the Digital Dyadic 
Empowerment Program (DDEP) compared to routine care, with a single follow-up 
assessment at 6 months post-baseline. This RCT will adhere to the Consolidated Standards of 
Reporting Trials (CONSORT) 2010 statement (Moher et al., 2010) and the CONSORT-
EHEALTH guidelines for digital health intervention evaluation (Eysenbach & CONSORT-
EHEALTH Group, 2011) to ensure rigorous reporting and transparency in the study design 
and outcomes. 
Participants 
Patients aged over 20 years and diagnosed with CKD at stage 1 to 5 for at least six months 
will be recruited with the following inclusion criteria: (1) patients can identify a helpful 
significant other, and both parties are willing to participate; (2) patients are able to 
communicate in Mandarin or Taiwanese. Patients will be excluded if (1) the significant other 
is a health care provider, (2) either the patient or significant other has a known mental illness 
diagnosis, (3) the patient is currently receiving renal replacement therapies, or (4) neither the 
patient nor the significant other uses a smartphone or the LINE messaging app. Patients who 

DDEP RANDOMIZED CONTROLLED TRIAL                  
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do not meet the smartphone or LINE app requirement will be excluded, as they would be 
unable to receive the intervention in the experimental group, ensuring rigorous 
randomization. 
Setting 
Subject will be recruited from outpatient clinics from a medical center in Southern Taiwan. 
Sample Size 
The estimated number of dyads will be based on the results of the Year 3 feasibility study, as 
a reference for calculating the effect and the rate of sample lost to follow-up. In the feasibility 
study, 60 dyads were recruited, and 55 completed the 3-month follow-up, resulting in a 
retention rate of 91.67%, which exceeds the 12-month retention rate of 64% reported by Teng 
and colleagues (2013) in a lifestyle modification program. For the formal RCT, the follow-up 
period has been shortened to 6 months. Efforts will be made to minimize attrition, targeting a 
dropout rate below 10%. Power analysis calculations, using G*Power software, indicate that 
for an effect size of 0.25 and a power of 0.8, a sample size of 76 dyads would be required. 
Adjusting for a 10% dropout rate, 84 dyads would be needed. To further safeguard against 
potential attrition and maintain robust subgroup analyses, the target recruitment will be 104 
dyads. Considering the recruitment efficiency demonstrated in the feasibility study, the plan 
to recruit 104 dyads remains feasible and appropriate to ensure sufficient power for detecting 
intervention effects. 
Measurements 
Data collection will consist of the following instruments: Demographics (e.g., age, gender, 
education level) and Disease Related Characteristics (e.g., estimated glomerular filtration rate 
[eGFR], CKD stage), TTM staging Inventory, Dyadic Adjustment Scale-7 (DAS-7), and 
Health Promoting Lifestyle Profile-II Chinese version revised (HPLP-IICR). 

DDEP RANDOMIZED CONTROLLED TRIAL                  
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Procedure 
Patients who meet the inclusion criteria will be referred to the study by nephrology outpatient 
clinic physicians at the study site. Patients attending their routine clinic visit to the 
nephrology clinic will be identified as potential subject if they meet the inclusion criteria. 
Dyads will be randomly assigned to either the experimental group or the control group using 
a pre-generated randomization list prepared via R programming’s sample function and by a 
research assistant. 
After assignment, the dyads will proceed to baseline assessment, which will include 
collecting demographic information, TTM stage of change, and other selected measures such 
as DAS-7 and HPLP-IICR. The dyads will complete the instruments in a private room, 
requiring approximately 15 minutes. Dyads assigned to the intervention group will receive 
the DDEP revised based on findings from year 3. This intervention will include the 
installation and usage of a digital platform to facilitate health-promoting behaviors and 
monitor outcomes. Control group participants will receive routine care without access to the 
DDEP platform during the study period but may join the platform after the study concludes. 
Outcome measures will be evaluated at baseline (T0) and six months post-baseline (T1). 
Participants will be compensated with a small gift after completing each data collection 
session. 
Data Analysis 
Descriptive statistics will be conducted to summarize demographic and clinical 
characteristics. For ordinal outcome variables, such as CKD stage and TTM stage of change, 
Fisher’s exact test will be used to examine the association between group assignment and pre-
to-post change categories (e.g., reverse, maintain, or progress for CKD; advance, maintain, or 
regress for TTM). 

DDEP RANDOMIZED CONTROLLED TRIAL                  
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Generalized Linear Mixed Models (GLMM) will be used to analyze differences between 
groups on continuous outcome indicators, considering the repeated-measures design of the 
study (Sharpe & Cribbie, 2023). The fixed effects in the models will include measurement 
time point (baseline and 6 months) and the interaction of group assignment (experimental vs. 
control) with time point, while random effects will include intercepts and time points to 
account for individual variability. Missing data will not be imputed. Analyses will be 
performed using IBM SPSS Statistics software (version 25.0). Statistical significance will be 
determined using a two-tailed p-value of < 0.05. 
A sensitivity analysis will be conducted to assess the robustness of findings under different 
analytic assumptions (Thabane et al., 2013). Specifically, per-protocol (PP) analysis will 
compare results for intention-to-treat (ITT) or modified intention-to-treat (mITT) groups 
(Ahn & Kang, 2023; McCoy, 2017). For experimental group participants, a sub-group 
analysis will classify participants as high or low platform users (based on a platform usage 
rate threshold of 50%) to explore the potential moderating effects of intervention adherence. 
 
 
 
 

DDEP RANDOMIZED CONTROLLED TRIAL                  
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References 
Ahn, E., & Kang, H. (2023). Intention-to-treat versus as-treated versus per-protocol 
 
approaches to analysis. Korean Journal of Anesthesiology, 76(6), 531–539. 
 
https://doi.org/10.4097/kja.23278 
Eysenbach, G., & CONSORT-EHEALTH Group (2011). CONSORT-EHEALTH: Improving 
 
and standardizing evaluation reports of Web-based and mobile health interventions. 
 
Journal of Medical Internet Research, 13(4), e126. https://doi.org/10.2196/jmir.1923 
McCoy, C. E. (2017). Understanding the intention-to-treat principle in randomized controlled 
 
trials. The Western Journal of Emergency Medicine, 18(6), 1075–1078. 
 
https://doi.org/10.5811/westjem.2017.8.35985 
Moher, D., Hopewell, S., Schulz, K. F., Montori, V., Gøtzsche, P. C., Devereaux, P. J., 
 
Elbourne, D., Egger, M., Altman, D. G., & Consolidated Standards of Reporting Trials 
 
Group (2010). CONSORT 2010 Explanation and Elaboration: Updated guidelines for 
 
reporting parallel group randomised trials. Journal of Clinical Epidemiology, 63(8), e1–
 
e37. https://doi.org/10.1016/j.jclinepi.2010.03.004 
Sharpe, D., & Cribbie, R. A. (2023). Analysis of treatment-control pre-post-follow-up design 
 
data. The Quantitative Methods for Psychology, 19(1), 25–46. 
 
https://doi.org/10.20982/tqmp.19.1.p025 
Teng, H.-L., Yen, M., Fetzer, S., Sung, J.-M., & Hung, S.-Y. (2013). Effects of targeted 
 
interventions on lifestyle modifications of chronic kidney disease patients: randomized 
 
controlled trial. Western Journal of Nursing Research, 35(9), 1107–1127. 
 
https://doi.org/10.1177/0193945913486202 
Thabane, L., Mbuagbaw, L., Zhang, S., Samaan, Z., Marcucci, M., Ye, C., Thabane, M., 
 
Giangregorio, L., Dennis, B., Kosa, D., Borg Debono, V., Dillenburg, R., Fruci, V., 
 
Bawor, M., Lee, J., Wells, G., & Goldsmith, C. H. (2013). A tutorial on sensitivity 

DDEP RANDOMIZED CONTROLLED TRIAL                  
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analyses in clinical trials: The what, why, when and how. BMC Medical Research 
 
Methodology, 13, 92. https://doi.org/10.1186/1471-2288-13-92 

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Institutional Review Board
National Cheng Kung University Hospital
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Ting-Tsung Chang M.D.
Chairman
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