Trial Outcomes & Findings for Effects of Personalized Actionable Connected Extensible (PACE) Interventions Among Patients With Chronic Kidney Disease (NCT NCT06065501)
NCT ID: NCT06065501
Last Updated: 2025-06-26
Results Overview
Frailty was measured using the Tilburg Frailty Indicator (TFI), a 15-item self-reported questionnaire assessing physical, psychological, and social domains. Total score ranges from 0 to 15, with higher scores indicating greater frailty.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
Baseline, 3 months, and 6 months post-intervention
Results posted on
2025-06-26
Participant Flow
Patients with CKD were recruited from outpatient clinics in hospitals located in southern Taiwan. The eligibility criteria included: (i) age 20 years or older; (ii) diagnosis of CKD stage 1 to 5 for at least 6 months; (iii) identified as frail; (iv) the ability to communicate in Mandarin Chinese or Taiwanese; and (v) willingness to participate in the study. The exclusion criteria were: (i) receiving renal replacement therapy, (ii) a history of mental illness, and (iii) having reached TTM stage 5
A total of 120 participants were enrolled and assigned to study arms.
Participant milestones
| Measure |
PACE Intervention
The intervention group (PACE intervention) utilizes mobile social network support, employing a LINE group to implement a personalized plan based on the TTM model for establishing a care program.
|
Control Group
The control group receives usual care, which involves standard CKD education and consultation.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
|
Overall Study
COMPLETED
|
38
|
58
|
|
Overall Study
NOT COMPLETED
|
22
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
PACE Intervention
n=60 Participants
The intervention group (PACE intervention) utilizes mobile social network support, employing a LINE group to implement a personalized plan based on the TTM model for establishing a care program.
|
Control Group
n=60 Participants
The control group receives usual care, which involves standard CKD education and consultation.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.70 Years
STANDARD_DEVIATION 13.25 • n=60 Participants
|
69.10 Years
STANDARD_DEVIATION 11.65 • n=60 Participants
|
67.90 Years
STANDARD_DEVIATION 12.48 • n=120 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=60 Participants
|
30 Participants
n=60 Participants
|
57 Participants
n=120 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=60 Participants
|
30 Participants
n=60 Participants
|
63 Participants
n=120 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Education Level
Middle school or below
|
22 Participants
n=60 Participants
|
30 Participants
n=60 Participants
|
52 Participants
n=120 Participants
|
|
Education Level
High school or college
|
27 Participants
n=60 Participants
|
23 Participants
n=60 Participants
|
50 Participants
n=120 Participants
|
|
Education Level
University or above
|
11 Participants
n=60 Participants
|
7 Participants
n=60 Participants
|
18 Participants
n=120 Participants
|
|
Marital Status
married
|
40 Participants
n=60 Participants
|
35 Participants
n=60 Participants
|
75 Participants
n=120 Participants
|
|
Marital Status
single
|
10 Participants
n=60 Participants
|
9 Participants
n=60 Participants
|
19 Participants
n=120 Participants
|
|
Marital Status
widowed
|
10 Participants
n=60 Participants
|
16 Participants
n=60 Participants
|
26 Participants
n=120 Participants
|
|
Living Status
lived alone
|
11 Participants
n=60 Participants
|
9 Participants
n=60 Participants
|
20 Participants
n=120 Participants
|
|
Living Status
living with family
|
49 Participants
n=60 Participants
|
51 Participants
n=60 Participants
|
100 Participants
n=120 Participants
|
|
Estimated Glomerular Filtration Rate (eGFR)
|
36.00 mL/min/1.73m²
STANDARD_DEVIATION 23.63 • n=60 Participants
|
39.92 mL/min/1.73m²
STANDARD_DEVIATION 20.34 • n=60 Participants
|
37.96 mL/min/1.73m²
STANDARD_DEVIATION 22.94 • n=120 Participants
|
|
Serum Albumin
|
4.30 g/dL
STANDARD_DEVIATION 0.53 • n=52 Participants • Some participants were excluded from albumin analysis due to missing blood test results at baseline.
|
4.28 g/dL
STANDARD_DEVIATION 0.38 • n=56 Participants • Some participants were excluded from albumin analysis due to missing blood test results at baseline.
|
4.29 g/dL
STANDARD_DEVIATION 0.46 • n=108 Participants • Some participants were excluded from albumin analysis due to missing blood test results at baseline.
|
|
Body Mass Index (BMI)
|
25.73 kg/m²
STANDARD_DEVIATION 5.85 • n=60 Participants • BMI data were missing for one participant in the control group due to incomplete height or weight records at baseline.
|
26.14 kg/m²
STANDARD_DEVIATION 4.74 • n=59 Participants • BMI data were missing for one participant in the control group due to incomplete height or weight records at baseline.
|
25.93 kg/m²
STANDARD_DEVIATION 5.31 • n=119 Participants • BMI data were missing for one participant in the control group due to incomplete height or weight records at baseline.
|
|
Hand Grip Strength
|
23.93 kg
STANDARD_DEVIATION 9.76 • n=58 Participants • Hand grip strength data were missing for three participants due to inability to complete the test or device-related issues at baseline.
|
23.31 kg
STANDARD_DEVIATION 10.82 • n=59 Participants • Hand grip strength data were missing for three participants due to inability to complete the test or device-related issues at baseline.
|
23.62 kg
STANDARD_DEVIATION 10.27 • n=117 Participants • Hand grip strength data were missing for three participants due to inability to complete the test or device-related issues at baseline.
|
PRIMARY outcome
Timeframe: Baseline, 3 months, and 6 months post-interventionFrailty was measured using the Tilburg Frailty Indicator (TFI), a 15-item self-reported questionnaire assessing physical, psychological, and social domains. Total score ranges from 0 to 15, with higher scores indicating greater frailty.
Outcome measures
| Measure |
PACE Intervention
n=60 Participants
The intervention group (PACE intervention) utilizes mobile social network support, employing a LINE group to implement a personalized plan based on the TTM model for establishing a care program.
PACE intervention: "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."
|
Control Group
n=60 Participants
The control group receives usual care, which involves standard CKD education and consultation.
Usual care: Nurses provide routine education and consultation
|
|---|---|---|
|
Tilburg Frailty Indicator (TFI)
Baseline
|
5.38 score on a scale
Standard Deviation 2.62
|
4.97 score on a scale
Standard Deviation 2.96
|
|
Tilburg Frailty Indicator (TFI)
3 months post-intervention
|
4.16 score on a scale
Standard Deviation 2.69
|
4.16 score on a scale
Standard Deviation 2.37
|
|
Tilburg Frailty Indicator (TFI)
6 months post-intervention
|
4.43 score on a scale
Standard Deviation 2.81
|
4.74 score on a scale
Standard Deviation 2.56
|
SECONDARY outcome
Timeframe: Baseline, 3 months, and 6 months post-interventionPhysical activity was assessed using the International Physical Activity Questionnaire - Taiwan version (IPAQ-Taiwan). Total physical activity score was calculated in MET-minutes/week, including walking, moderate, and vigorous intensity activities.
Outcome measures
| Measure |
PACE Intervention
n=60 Participants
The intervention group (PACE intervention) utilizes mobile social network support, employing a LINE group to implement a personalized plan based on the TTM model for establishing a care program.
PACE intervention: "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."
|
Control Group
n=60 Participants
The control group receives usual care, which involves standard CKD education and consultation.
Usual care: Nurses provide routine education and consultation
|
|---|---|---|
|
Physical Activity Level Measured by IPAQ-Taiwan
Baseline
|
3650.88 MET-minutes/week
Standard Deviation 2057.09
|
3971.91 MET-minutes/week
Standard Deviation 3647.70
|
|
Physical Activity Level Measured by IPAQ-Taiwan
3 months post-intervention
|
3248.18 MET-minutes/week
Standard Deviation 1950.36
|
3891.37 MET-minutes/week
Standard Deviation 2747.92
|
|
Physical Activity Level Measured by IPAQ-Taiwan
6 months post-intervention
|
3588.53 MET-minutes/week
Standard Deviation 2117.56
|
3259.35 MET-minutes/week
Standard Deviation 2140.04
|
SECONDARY outcome
Timeframe: Baseline, 3 months, and 6 months post-interventionLifestyle behaviors were assessed using the HPLP-II, Taiwan version, including six subscales. Scores range from 52 to 208, with higher scores indicating more frequent health-promoting behaviors.
Outcome measures
| Measure |
PACE Intervention
n=60 Participants
The intervention group (PACE intervention) utilizes mobile social network support, employing a LINE group to implement a personalized plan based on the TTM model for establishing a care program.
PACE intervention: "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."
|
Control Group
n=60 Participants
The control group receives usual care, which involves standard CKD education and consultation.
Usual care: Nurses provide routine education and consultation
|
|---|---|---|
|
Health-promoting Lifestyle Behaviors (HPLP-II, Taiwan Version)
Baseline
|
149 scores on a scale
Standard Deviation 19.93
|
144.6 scores on a scale
Standard Deviation 21.23
|
|
Health-promoting Lifestyle Behaviors (HPLP-II, Taiwan Version)
3 months post-intervention
|
152.93 scores on a scale
Standard Deviation 19.71
|
149.60 scores on a scale
Standard Deviation 20.21
|
|
Health-promoting Lifestyle Behaviors (HPLP-II, Taiwan Version)
6 months post-intervention
|
149.81 scores on a scale
Standard Deviation 24.35
|
142.46 scores on a scale
Standard Deviation 25.72
|
SECONDARY outcome
Timeframe: Baseline, 3 months, and 6 months post-interventionNutritional status was assessed using the Mini Nutritional Assessment - Short Form (MNA-SF), a 6-item tool scored 0-14. Higher scores indicate better nutritional status. A score ≥12 is considered normal. The Taiwan version was used.
Outcome measures
| Measure |
PACE Intervention
n=60 Participants
The intervention group (PACE intervention) utilizes mobile social network support, employing a LINE group to implement a personalized plan based on the TTM model for establishing a care program.
PACE intervention: "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."
|
Control Group
n=60 Participants
The control group receives usual care, which involves standard CKD education and consultation.
Usual care: Nurses provide routine education and consultation
|
|---|---|---|
|
Nutritional Status Measured by MNA-SF
Baseline
|
12.25 score on a scale
Standard Deviation 1.76
|
12.55 score on a scale
Standard Deviation 1.60
|
|
Nutritional Status Measured by MNA-SF
3 months post-intervention
|
12.49 score on a scale
Standard Deviation 1.30
|
12.59 score on a scale
Standard Deviation 1.61
|
|
Nutritional Status Measured by MNA-SF
6 months post-intervention
|
12.42 score on a scale
Standard Deviation 1.58
|
12.35 score on a scale
Standard Deviation 1.86
|
Adverse Events
PACE Intervention
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PACE Intervention
n=60 participants at risk
The intervention group (PACE intervention) utilizes mobile social network support, employing a LINE group to implement a personalized plan based on the TTM model for establishing a care program.
|
Control Group
n=60 participants at risk
The control group receives usual care, which involves standard CKD education and consultation.
|
|---|---|---|
|
General disorders
Death, cause unknown
|
1.7%
1/60 • Number of events 1 • From baseline to the final follow-up at 6 months post-intervention.
Adverse event data were collected systematically at baseline, 3 months, and 6 months via participant interviews. Definitions aligned with ClinicalTrials.gov.
|
0.00%
0/60 • From baseline to the final follow-up at 6 months post-intervention.
Adverse event data were collected systematically at baseline, 3 months, and 6 months via participant interviews. Definitions aligned with ClinicalTrials.gov.
|
Other adverse events
| Measure |
PACE Intervention
n=60 participants at risk
The intervention group (PACE intervention) utilizes mobile social network support, employing a LINE group to implement a personalized plan based on the TTM model for establishing a care program.
|
Control Group
n=60 participants at risk
The control group receives usual care, which involves standard CKD education and consultation.
|
|---|---|---|
|
General disorders
No other adverse events reported
|
0.00%
0/60 • From baseline to the final follow-up at 6 months post-intervention.
Adverse event data were collected systematically at baseline, 3 months, and 6 months via participant interviews. Definitions aligned with ClinicalTrials.gov.
|
0.00%
0/60 • From baseline to the final follow-up at 6 months post-intervention.
Adverse event data were collected systematically at baseline, 3 months, and 6 months via participant interviews. Definitions aligned with ClinicalTrials.gov.
|
Additional Information
Professor Miaofen Yen / Professor of Nursing department
National Cheng Kung University
Phone: 886-6-2353535
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place