Frailty Trajectories and Effects of Personalized Actionable Connected Extensible (PACE) Interventions Among Patients With Chronic Kidney Disease: A Longitudinal Study
Phase: NA
Conditions: CKD - Chronic Kidney Disease
Sponsor: National Cheng Kung University

Document Type: 
Study Protocol with Statistical Analysis Plan (SAP) 
 
Official Title of Study: 
Effects of Personalized Actionable Connected Extensible (PACE) Interventions 
Among Patients With Chronic Kidney Disease 
 
NCT Number: 
NCT06065501 
 
Document Date: 
05/20/2025 
 
Subtitle: 
Main Protocol – Taiwan Implementation Site 
 
Sponsor: 
National Cheng Kung University Hospital 
 
Principal Investigator: 
Miaofen Yen, PhD(c), RN 
 

 
Study Objectives: To examine the effectiveness Personalized Actionable Connected Extensible 
(PACE) Interventions for frailty among patients with CKD. 
 
Study Design: A randomized controlled trial with a single-blinded experimental design.  
 
Eligibility Criteria:  
1. The eligibility criteria included: (1) age 20 years or older; (2) diagnosis of CKD stage 1 to 5 
for at least 6 months; (3) identified as frail; (4) the ability to communicate in Mandarin 
Chinese or Taiwanese; and (5) willingness to participate in the study.  
2. The exclusion criteria were: (1) receiving renal replacement therapy, (2) a history of mental 
illness, and (3) having reached TTM stage 5. 
 
Intervention/Comparator Descriptions: 
1. The PACE intervention involves using Line (technological devices) to establish a 
collaborative group with patients. The researchers will regularly provide reminders to 
chronic kidney disease patients regarding the importance of nutrition and exercise. They 
will also provide information on how to adhere to nutritional and exercise regimens, 
offering praise for consistent performance. 
2. Nurses provide routine education and consultation. 
 
Outcome Measures: 
1. Primary Outcome Measure: Tilburg Frailty Indicator (TFI) 
2. Secondary Outcome Measures: International Physical Activity Questionnaires (IPAQ, 
Taiwan Version); Health-promoting Lifestyle Behaviors (HPLP-II, Taiwan Version); Mini 
Nutritional Assessment Short-Form (MNA-SF, Taiwan Version) 
 
Statistical Analysis Plan:  
1. Descriptive Statistics: Mean ± SD for continuous variables, Frequency (%) for categorical 
variables 
2. Comparative Analysis: Generalized estimating equations (GEE) are used to account for the 
non-independence of repeated measures over time within individuals and to control for 
potential confounding factors. The GEE models included main effects for group 
(intervention vs. control), time, and group-by-time interaction terms to examine whether 
there were statistically significant differences in outcome trajectories between the two 
groups over time. Covariates controlled in the models included age and gender. A 
significance level of 0.05 was used for hypothesis testing. All analyses were conducted 
using SPSS 25 version software.