Trial Outcomes & Findings for Digital Dyadic Empowerment Program on Lifestyle Modification for Chronic Kidney Disease Management (NCT NCT06756113)
NCT ID: NCT06756113
Last Updated: 2026-02-12
Results Overview
For each patient, change from Baseline (Followup score - Baseline score) in the estimated Glomerular Filtration Rate (eGFR) by the Isotope Dilution Mass Spectrometry - Modification of Diet in Renal Disease (IDMS-MDRD) Equation at 6 months was obtained through the patient's biochemical test reports. Higher eGFR numbers generally indicate better kidney functions.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
208 participants
Primary outcome timeframe
Before initial intervention and 6 months after initial intervention
Results posted on
2026-02-12
Participant Flow
The "Enrollment" number (i.e., 208) in the Study Design Section reflects the total number of \*participants\* enrolled. After enrollment, 52 dyads (i.e., 52 patients and their 52 significant others) were randomly allocated to each group.
Participant milestones
| Measure |
Intervention Group (Digital Dyadic Empowerment + Usual Care)
The intervention group (Digital Dyadic Empowerment + Usual Care) will use a platform based on LINE, a prominent instant messaging App in Taiwan. The platform is named "Kidney Lifestyle," consisted of a LINE Official Account (OA) and an extended App.
The primary objective of Digital Dyadic Empowerment is to encourage CKD dyads (patients and their significant others \[SOs\]) in modifying health-related lifestyles through the platform and instant messaging support. The main features include:
1. Health Education Information: Providing basic CKD management knowledge via interactive messages.
2. Kidney Support Teammate: Offering supportive resources for caregivers (significant others).
3. Record Values: Allowing users to track physiological measurements at home through the extended App.
4. Reminders Settings: Automatically sending messages to remind users of outpatient visits and daily self-management tasks.
5. Kidney Health Mission: Facilitating daily recording of diet, medication intake, and physical activity through the extended App.
6. Inquiry \& Consultation: Providing common CKD-related Q\&A and consultation channels through interactive messages.
The use of the platform is not restricted by time or location, allowing CKD dyads to engage flexibly based on their needs or healthcare providers' instructions. Specifically, users are encouraged to engage daily with two main features, "Record Values" and "Kidney Health Mission," to document their lifestyle modification progress.
|
Control Group (Usual Care Only)
All study participants received regular checkups and treatments at the nephrology clinics of National Cheng Kung University Hospital. Nephrologists diagnosed and explained disease progression, treatment plans, prognosis, and risks based on clinical assessments. Care plans included medication adherence, home blood pressure monitoring, dietary adjustments, and regular physical activity. Participants also received nephrology nursing or nutritional counseling through the hospital's Health Education Center.
|
|---|---|---|
|
Overall Study
STARTED
|
104
|
104
|
|
Overall Study
COMPLETED
|
101
|
87
|
|
Overall Study
NOT COMPLETED
|
3
|
17
|
Reasons for withdrawal
| Measure |
Intervention Group (Digital Dyadic Empowerment + Usual Care)
The intervention group (Digital Dyadic Empowerment + Usual Care) will use a platform based on LINE, a prominent instant messaging App in Taiwan. The platform is named "Kidney Lifestyle," consisted of a LINE Official Account (OA) and an extended App.
The primary objective of Digital Dyadic Empowerment is to encourage CKD dyads (patients and their significant others \[SOs\]) in modifying health-related lifestyles through the platform and instant messaging support. The main features include:
1. Health Education Information: Providing basic CKD management knowledge via interactive messages.
2. Kidney Support Teammate: Offering supportive resources for caregivers (significant others).
3. Record Values: Allowing users to track physiological measurements at home through the extended App.
4. Reminders Settings: Automatically sending messages to remind users of outpatient visits and daily self-management tasks.
5. Kidney Health Mission: Facilitating daily recording of diet, medication intake, and physical activity through the extended App.
6. Inquiry \& Consultation: Providing common CKD-related Q\&A and consultation channels through interactive messages.
The use of the platform is not restricted by time or location, allowing CKD dyads to engage flexibly based on their needs or healthcare providers' instructions. Specifically, users are encouraged to engage daily with two main features, "Record Values" and "Kidney Health Mission," to document their lifestyle modification progress.
|
Control Group (Usual Care Only)
All study participants received regular checkups and treatments at the nephrology clinics of National Cheng Kung University Hospital. Nephrologists diagnosed and explained disease progression, treatment plans, prognosis, and risks based on clinical assessments. Care plans included medication adherence, home blood pressure monitoring, dietary adjustments, and regular physical activity. Participants also received nephrology nursing or nutritional counseling through the hospital's Health Education Center.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
17
|
Baseline Characteristics
All 208 participants completed the baseline measure of Age. However, averaging the age of each dyad is not of great interest to our study and could be misleading as the role of the significant other (e.g., the patient's spouse, child, or grandchild) is not taken into account. Therefore, we report the distribution of age for patient and significant other separately.
Baseline characteristics by cohort
| Measure |
Intervention Group (Digital Dyadic Empowerment + Usual Care)
n=104 Participants
The intervention group (Digital Dyadic Empowerment + Usual Care) will use a platform based on LINE, a prominent instant messaging App in Taiwan. The platform is named "Kidney Lifestyle," consisted of a LINE Official Account (OA) and an extended App.
The primary objective of Digital Dyadic Empowerment is to encourage CKD dyads (patients and their significant others \[SOs\]) in modifying health-related lifestyles through the platform and instant messaging support. The main features include:
1. Health Education Information: Providing basic CKD management knowledge via interactive messages.
2. Kidney Support Teammate: Offering supportive resources for caregivers (significant others).
3. Record Values: Allowing users to track physiological measurements at home through the extended App.
4. Reminders Settings: Automatically sending messages to remind users of outpatient visits and daily self-management tasks.
5. Kidney Health Mission: Facilitating daily recording of diet, medication intake, and physical activity through the extended App.
6. Inquiry \& Consultation: Providing common CKD-related Q\&A and consultation channels through interactive messages.
The use of the platform is not restricted by time or location, allowing CKD dyads to engage flexibly based on their needs or healthcare providers' instructions. Specifically, users are encouraged to engage daily with two main features, "Record Values" and "Kidney Health Mission," to document their lifestyle modification progress.
|
Control Group (Usual Care Only)
n=104 Participants
All study participants received regular checkups and treatments at the nephrology clinics of National Cheng Kung University Hospital. Nephrologists diagnosed and explained disease progression, treatment plans, prognosis, and risks based on clinical assessments. Care plans included medication adherence, home blood pressure monitoring, dietary adjustments, and regular physical activity. Participants also received nephrology nursing or nutritional counseling through the hospital's Health Education Center.
|
Total
n=208 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Patient
|
66.23 years
STANDARD_DEVIATION 15.19 • n=52 Participants • All 208 participants completed the baseline measure of Age. However, averaging the age of each dyad is not of great interest to our study and could be misleading as the role of the significant other (e.g., the patient's spouse, child, or grandchild) is not taken into account. Therefore, we report the distribution of age for patient and significant other separately.
|
69.81 years
STANDARD_DEVIATION 12.40 • n=52 Participants • All 208 participants completed the baseline measure of Age. However, averaging the age of each dyad is not of great interest to our study and could be misleading as the role of the significant other (e.g., the patient's spouse, child, or grandchild) is not taken into account. Therefore, we report the distribution of age for patient and significant other separately.
|
68.02 years
STANDARD_DEVIATION 13.92 • n=104 Participants • All 208 participants completed the baseline measure of Age. However, averaging the age of each dyad is not of great interest to our study and could be misleading as the role of the significant other (e.g., the patient's spouse, child, or grandchild) is not taken into account. Therefore, we report the distribution of age for patient and significant other separately.
|
|
Age, Continuous
Significant other
|
57.63 years
STANDARD_DEVIATION 12.05 • n=52 Participants • All 208 participants completed the baseline measure of Age. However, averaging the age of each dyad is not of great interest to our study and could be misleading as the role of the significant other (e.g., the patient's spouse, child, or grandchild) is not taken into account. Therefore, we report the distribution of age for patient and significant other separately.
|
59.35 years
STANDARD_DEVIATION 13.22 • n=52 Participants • All 208 participants completed the baseline measure of Age. However, averaging the age of each dyad is not of great interest to our study and could be misleading as the role of the significant other (e.g., the patient's spouse, child, or grandchild) is not taken into account. Therefore, we report the distribution of age for patient and significant other separately.
|
58.49 years
STANDARD_DEVIATION 12.62 • n=104 Participants • All 208 participants completed the baseline measure of Age. However, averaging the age of each dyad is not of great interest to our study and could be misleading as the role of the significant other (e.g., the patient's spouse, child, or grandchild) is not taken into account. Therefore, we report the distribution of age for patient and significant other separately.
|
|
eGFR
|
50.69 mL/min/1.73m^2
STANDARD_DEVIATION 23.39 • n=51 Participants • This measure includes patient only. All 104 patients had baseline eGFR data available. One physiologically implausible value (195.82) from a patient in the intervention group was excluded, leaving 103 datapoints for this measure.
|
46.99 mL/min/1.73m^2
STANDARD_DEVIATION 27.24 • n=52 Participants • This measure includes patient only. All 104 patients had baseline eGFR data available. One physiologically implausible value (195.82) from a patient in the intervention group was excluded, leaving 103 datapoints for this measure.
|
48.82 mL/min/1.73m^2
STANDARD_DEVIATION 25.35 • n=103 Participants • This measure includes patient only. All 104 patients had baseline eGFR data available. One physiologically implausible value (195.82) from a patient in the intervention group was excluded, leaving 103 datapoints for this measure.
|
|
Sex: Female, Male
Patient · Female
|
25 Participants
n=52 Participants • All 208 participants completed the baseline measure of Sex. However, the count of sex for all participants together is not of great interest to our study and could be misleading as the role of the significant other (e.g., the patient's spouse, child, or grandchild) is not taken into account. Therefore, we report the count of sex for patient and significant other separately.
|
26 Participants
n=52 Participants • All 208 participants completed the baseline measure of Sex. However, the count of sex for all participants together is not of great interest to our study and could be misleading as the role of the significant other (e.g., the patient's spouse, child, or grandchild) is not taken into account. Therefore, we report the count of sex for patient and significant other separately.
|
51 Participants
n=104 Participants • All 208 participants completed the baseline measure of Sex. However, the count of sex for all participants together is not of great interest to our study and could be misleading as the role of the significant other (e.g., the patient's spouse, child, or grandchild) is not taken into account. Therefore, we report the count of sex for patient and significant other separately.
|
|
Sex: Female, Male
Patient · Male
|
27 Participants
n=52 Participants • All 208 participants completed the baseline measure of Sex. However, the count of sex for all participants together is not of great interest to our study and could be misleading as the role of the significant other (e.g., the patient's spouse, child, or grandchild) is not taken into account. Therefore, we report the count of sex for patient and significant other separately.
|
26 Participants
n=52 Participants • All 208 participants completed the baseline measure of Sex. However, the count of sex for all participants together is not of great interest to our study and could be misleading as the role of the significant other (e.g., the patient's spouse, child, or grandchild) is not taken into account. Therefore, we report the count of sex for patient and significant other separately.
|
53 Participants
n=104 Participants • All 208 participants completed the baseline measure of Sex. However, the count of sex for all participants together is not of great interest to our study and could be misleading as the role of the significant other (e.g., the patient's spouse, child, or grandchild) is not taken into account. Therefore, we report the count of sex for patient and significant other separately.
|
|
Sex: Female, Male
Significant other · Female
|
36 Participants
n=52 Participants • All 208 participants completed the baseline measure of Sex. However, the count of sex for all participants together is not of great interest to our study and could be misleading as the role of the significant other (e.g., the patient's spouse, child, or grandchild) is not taken into account. Therefore, we report the count of sex for patient and significant other separately.
|
31 Participants
n=52 Participants • All 208 participants completed the baseline measure of Sex. However, the count of sex for all participants together is not of great interest to our study and could be misleading as the role of the significant other (e.g., the patient's spouse, child, or grandchild) is not taken into account. Therefore, we report the count of sex for patient and significant other separately.
|
67 Participants
n=104 Participants • All 208 participants completed the baseline measure of Sex. However, the count of sex for all participants together is not of great interest to our study and could be misleading as the role of the significant other (e.g., the patient's spouse, child, or grandchild) is not taken into account. Therefore, we report the count of sex for patient and significant other separately.
|
|
Sex: Female, Male
Significant other · Male
|
16 Participants
n=52 Participants • All 208 participants completed the baseline measure of Sex. However, the count of sex for all participants together is not of great interest to our study and could be misleading as the role of the significant other (e.g., the patient's spouse, child, or grandchild) is not taken into account. Therefore, we report the count of sex for patient and significant other separately.
|
21 Participants
n=52 Participants • All 208 participants completed the baseline measure of Sex. However, the count of sex for all participants together is not of great interest to our study and could be misleading as the role of the significant other (e.g., the patient's spouse, child, or grandchild) is not taken into account. Therefore, we report the count of sex for patient and significant other separately.
|
37 Participants
n=104 Participants • All 208 participants completed the baseline measure of Sex. However, the count of sex for all participants together is not of great interest to our study and could be misleading as the role of the significant other (e.g., the patient's spouse, child, or grandchild) is not taken into account. Therefore, we report the count of sex for patient and significant other separately.
|
|
CKD Stage
Stage 1
|
5 Participants
n=52 Participants • This measure includes patient only. All 104 patients had baseline CKD Stage data available.
|
5 Participants
n=52 Participants • This measure includes patient only. All 104 patients had baseline CKD Stage data available.
|
10 Participants
n=104 Participants • This measure includes patient only. All 104 patients had baseline CKD Stage data available.
|
|
CKD Stage
Stage 2
|
11 Participants
n=52 Participants • This measure includes patient only. All 104 patients had baseline CKD Stage data available.
|
8 Participants
n=52 Participants • This measure includes patient only. All 104 patients had baseline CKD Stage data available.
|
19 Participants
n=104 Participants • This measure includes patient only. All 104 patients had baseline CKD Stage data available.
|
|
CKD Stage
Stage 3a
|
11 Participants
n=52 Participants • This measure includes patient only. All 104 patients had baseline CKD Stage data available.
|
14 Participants
n=52 Participants • This measure includes patient only. All 104 patients had baseline CKD Stage data available.
|
25 Participants
n=104 Participants • This measure includes patient only. All 104 patients had baseline CKD Stage data available.
|
|
CKD Stage
Stage 3b
|
16 Participants
n=52 Participants • This measure includes patient only. All 104 patients had baseline CKD Stage data available.
|
10 Participants
n=52 Participants • This measure includes patient only. All 104 patients had baseline CKD Stage data available.
|
26 Participants
n=104 Participants • This measure includes patient only. All 104 patients had baseline CKD Stage data available.
|
|
TTM Stage
Preparation
|
7 Participants
n=52 Participants • This measure includes patient only. All 104 patients had baseline TTM Stage data available.
|
1 Participants
n=52 Participants • This measure includes patient only. All 104 patients had baseline TTM Stage data available.
|
8 Participants
n=104 Participants • This measure includes patient only. All 104 patients had baseline TTM Stage data available.
|
|
CKD Stage
Stage 4
|
6 Participants
n=52 Participants • This measure includes patient only. All 104 patients had baseline CKD Stage data available.
|
8 Participants
n=52 Participants • This measure includes patient only. All 104 patients had baseline CKD Stage data available.
|
14 Participants
n=104 Participants • This measure includes patient only. All 104 patients had baseline CKD Stage data available.
|
|
CKD Stage
Stage 5
|
3 Participants
n=52 Participants • This measure includes patient only. All 104 patients had baseline CKD Stage data available.
|
7 Participants
n=52 Participants • This measure includes patient only. All 104 patients had baseline CKD Stage data available.
|
10 Participants
n=104 Participants • This measure includes patient only. All 104 patients had baseline CKD Stage data available.
|
|
TTM Stage
Precontemplation
|
1 Participants
n=52 Participants • This measure includes patient only. All 104 patients had baseline TTM Stage data available.
|
2 Participants
n=52 Participants • This measure includes patient only. All 104 patients had baseline TTM Stage data available.
|
3 Participants
n=104 Participants • This measure includes patient only. All 104 patients had baseline TTM Stage data available.
|
|
TTM Stage
Contemplation
|
2 Participants
n=52 Participants • This measure includes patient only. All 104 patients had baseline TTM Stage data available.
|
1 Participants
n=52 Participants • This measure includes patient only. All 104 patients had baseline TTM Stage data available.
|
3 Participants
n=104 Participants • This measure includes patient only. All 104 patients had baseline TTM Stage data available.
|
|
TTM Stage
Action
|
7 Participants
n=52 Participants • This measure includes patient only. All 104 patients had baseline TTM Stage data available.
|
13 Participants
n=52 Participants • This measure includes patient only. All 104 patients had baseline TTM Stage data available.
|
20 Participants
n=104 Participants • This measure includes patient only. All 104 patients had baseline TTM Stage data available.
|
|
TTM Stage
Maintenance
|
35 Participants
n=52 Participants • This measure includes patient only. All 104 patients had baseline TTM Stage data available.
|
35 Participants
n=52 Participants • This measure includes patient only. All 104 patients had baseline TTM Stage data available.
|
70 Participants
n=104 Participants • This measure includes patient only. All 104 patients had baseline TTM Stage data available.
|
|
Health Promoting Lifestyle
|
84.58 units on a scale
STANDARD_DEVIATION 16.74 • n=52 Participants • This measure includes patient only. All 104 patients had baseline HPLP-IICR data available.
|
87.23 units on a scale
STANDARD_DEVIATION 15.27 • n=52 Participants • This measure includes patient only. All 104 patients had baseline HPLP-IICR data available.
|
85.90 units on a scale
STANDARD_DEVIATION 16.00 • n=104 Participants • This measure includes patient only. All 104 patients had baseline HPLP-IICR data available.
|
|
Dyadic Adjustment
Patient
|
23.40 units on a scale
STANDARD_DEVIATION 7.08 • n=52 Participants • All 208 participants completed the baseline measure of DAS-7. We report the score distribution for patient and significant other separately.
|
25.71 units on a scale
STANDARD_DEVIATION 7.30 • n=52 Participants • All 208 participants completed the baseline measure of DAS-7. We report the score distribution for patient and significant other separately.
|
24.56 units on a scale
STANDARD_DEVIATION 7.25 • n=104 Participants • All 208 participants completed the baseline measure of DAS-7. We report the score distribution for patient and significant other separately.
|
|
Dyadic Adjustment
Significant other
|
21.96 units on a scale
STANDARD_DEVIATION 6.64 • n=52 Participants • All 208 participants completed the baseline measure of DAS-7. We report the score distribution for patient and significant other separately.
|
23.83 units on a scale
STANDARD_DEVIATION 7.46 • n=52 Participants • All 208 participants completed the baseline measure of DAS-7. We report the score distribution for patient and significant other separately.
|
22.89 units on a scale
STANDARD_DEVIATION 7.09 • n=104 Participants • All 208 participants completed the baseline measure of DAS-7. We report the score distribution for patient and significant other separately.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Before initial intervention and 6 months after initial interventionPopulation: The test of eGFR was conducted only on patient participants. For follow-up, 50 patients from the intervention and 43 patients from the control group completed the eGFR measure.
For each patient, change from Baseline (Followup score - Baseline score) in the estimated Glomerular Filtration Rate (eGFR) by the Isotope Dilution Mass Spectrometry - Modification of Diet in Renal Disease (IDMS-MDRD) Equation at 6 months was obtained through the patient's biochemical test reports. Higher eGFR numbers generally indicate better kidney functions.
Outcome measures
| Measure |
Intervention Group (Digital Dyadic Empowerment + Usual Care)
n=50 Participants
The intervention group (Digital Dyadic Empowerment + Usual Care) will use a platform based on LINE, a prominent instant messaging App in Taiwan. The platform is named "Kidney Lifestyle," consisted of a LINE Official Account (OA) and an extended App.
The primary objective of Digital Dyadic Empowerment is to encourage CKD dyads (patients and their significant others \[SOs\]) in modifying health-related lifestyles through the platform and instant messaging support. The main features include:
1. Health Education Information: Providing basic CKD management knowledge via interactive messages.
2. Kidney Support Teammate: Offering supportive resources for caregivers (significant others).
3. Record Values: Allowing users to track physiological measurements at home through the extended App.
4. Reminders Settings: Automatically sending messages to remind users of outpatient visits and daily self-management tasks.
5. Kidney Health Mission: Facilitating daily recording of diet, medication intake, and physical activity through the extended App.
6. Inquiry \& Consultation: Providing common CKD-related Q\&A and consultation channels through interactive messages.
The use of the platform is not restricted by time or location, allowing CKD dyads to engage flexibly based on their needs or healthcare providers' instructions. Specifically, users are encouraged to engage daily with two main features, "Record Values" and "Kidney Health Mission," to document their lifestyle modification progress.
|
Control Group (Usual Care Only)
n=43 Participants
All study participants received regular checkups and treatments at the nephrology clinics of National Cheng Kung University Hospital. Nephrologists diagnosed and explained disease progression, treatment plans, prognosis, and risks based on clinical assessments. Care plans included medication adherence, home blood pressure monitoring, dietary adjustments, and regular physical activity. Participants also received nephrology nursing or nutritional counseling through the hospital's Health Education Center.
|
|---|---|---|
|
Change From Baseline in eGFR at 6 Months (Patient-specific)
|
-2.35 mL/min/1.73m^2
Standard Error 1.31
|
-4.24 mL/min/1.73m^2
Standard Error 1.17
|
SECONDARY outcome
Timeframe: Before initial intervention and 6 months after initial interventionPopulation: The test of CKD Stage was conducted only on patient participants. For follow-up, 50 patients from the intervention and 43 patients from the control group completed the CKD Stage measure.
For each patient, change from Baseline in CKD stage at 6 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 \[at follow-up\]).
Outcome measures
| Measure |
Intervention Group (Digital Dyadic Empowerment + Usual Care)
n=50 Participants
The intervention group (Digital Dyadic Empowerment + Usual Care) will use a platform based on LINE, a prominent instant messaging App in Taiwan. The platform is named "Kidney Lifestyle," consisted of a LINE Official Account (OA) and an extended App.
The primary objective of Digital Dyadic Empowerment is to encourage CKD dyads (patients and their significant others \[SOs\]) in modifying health-related lifestyles through the platform and instant messaging support. The main features include:
1. Health Education Information: Providing basic CKD management knowledge via interactive messages.
2. Kidney Support Teammate: Offering supportive resources for caregivers (significant others).
3. Record Values: Allowing users to track physiological measurements at home through the extended App.
4. Reminders Settings: Automatically sending messages to remind users of outpatient visits and daily self-management tasks.
5. Kidney Health Mission: Facilitating daily recording of diet, medication intake, and physical activity through the extended App.
6. Inquiry \& Consultation: Providing common CKD-related Q\&A and consultation channels through interactive messages.
The use of the platform is not restricted by time or location, allowing CKD dyads to engage flexibly based on their needs or healthcare providers' instructions. Specifically, users are encouraged to engage daily with two main features, "Record Values" and "Kidney Health Mission," to document their lifestyle modification progress.
|
Control Group (Usual Care Only)
n=43 Participants
All study participants received regular checkups and treatments at the nephrology clinics of National Cheng Kung University Hospital. Nephrologists diagnosed and explained disease progression, treatment plans, prognosis, and risks based on clinical assessments. Care plans included medication adherence, home blood pressure monitoring, dietary adjustments, and regular physical activity. Participants also received nephrology nursing or nutritional counseling through the hospital's Health Education Center.
|
|---|---|---|
|
Change From Baseline in CKD Stage at 6 Months (Patient-specific)
Recover
|
6 Participants
|
1 Participants
|
|
Change From Baseline in CKD Stage at 6 Months (Patient-specific)
Stable
|
37 Participants
|
31 Participants
|
|
Change From Baseline in CKD Stage at 6 Months (Patient-specific)
Progress
|
7 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Before initial intervention and 6 months after initial interventionPopulation: The test of TTM Stage was conducted only on patient participants. For follow-up, 51 patients from the intervention and 44 patients from the control group completed the TTM Stage measure.
For each patient, change from Baseline in TTM stage at 6 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 Maintenance \[at follow-up\]).
Outcome measures
| Measure |
Intervention Group (Digital Dyadic Empowerment + Usual Care)
n=51 Participants
The intervention group (Digital Dyadic Empowerment + Usual Care) will use a platform based on LINE, a prominent instant messaging App in Taiwan. The platform is named "Kidney Lifestyle," consisted of a LINE Official Account (OA) and an extended App.
The primary objective of Digital Dyadic Empowerment is to encourage CKD dyads (patients and their significant others \[SOs\]) in modifying health-related lifestyles through the platform and instant messaging support. The main features include:
1. Health Education Information: Providing basic CKD management knowledge via interactive messages.
2. Kidney Support Teammate: Offering supportive resources for caregivers (significant others).
3. Record Values: Allowing users to track physiological measurements at home through the extended App.
4. Reminders Settings: Automatically sending messages to remind users of outpatient visits and daily self-management tasks.
5. Kidney Health Mission: Facilitating daily recording of diet, medication intake, and physical activity through the extended App.
6. Inquiry \& Consultation: Providing common CKD-related Q\&A and consultation channels through interactive messages.
The use of the platform is not restricted by time or location, allowing CKD dyads to engage flexibly based on their needs or healthcare providers' instructions. Specifically, users are encouraged to engage daily with two main features, "Record Values" and "Kidney Health Mission," to document their lifestyle modification progress.
|
Control Group (Usual Care Only)
n=44 Participants
All study participants received regular checkups and treatments at the nephrology clinics of National Cheng Kung University Hospital. Nephrologists diagnosed and explained disease progression, treatment plans, prognosis, and risks based on clinical assessments. Care plans included medication adherence, home blood pressure monitoring, dietary adjustments, and regular physical activity. Participants also received nephrology nursing or nutritional counseling through the hospital's Health Education Center.
|
|---|---|---|
|
Change From Baseline in TTM Stage at 6 Months (Patient-specific)
Regress
|
8 Participants
|
5 Participants
|
|
Change From Baseline in TTM Stage at 6 Months (Patient-specific)
Maintain
|
33 Participants
|
33 Participants
|
|
Change From Baseline in TTM Stage at 6 Months (Patient-specific)
Advance
|
10 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Before initial intervention and 6 months after initial interventionPopulation: This measure was conducted only on patient participants. For follow-up, 51 patients from the intervention and 44 patients from the control group completed the HPLP-IICR measure.
For each patient, change from Baseline (Followup score - Baseline score) in patient's Health Promoting Lifestyle at 6 months was assessed using the Health Promoting Lifestyle Profile-II Chinese version Revised (HPLP-IICR), a validated scale with 30 items rated on a 4-point Likert scale. The total scores range from 30 to 120, with higher scores indicate better health-promoting lifestyle.
Outcome measures
| Measure |
Intervention Group (Digital Dyadic Empowerment + Usual Care)
n=51 Participants
The intervention group (Digital Dyadic Empowerment + Usual Care) will use a platform based on LINE, a prominent instant messaging App in Taiwan. The platform is named "Kidney Lifestyle," consisted of a LINE Official Account (OA) and an extended App.
The primary objective of Digital Dyadic Empowerment is to encourage CKD dyads (patients and their significant others \[SOs\]) in modifying health-related lifestyles through the platform and instant messaging support. The main features include:
1. Health Education Information: Providing basic CKD management knowledge via interactive messages.
2. Kidney Support Teammate: Offering supportive resources for caregivers (significant others).
3. Record Values: Allowing users to track physiological measurements at home through the extended App.
4. Reminders Settings: Automatically sending messages to remind users of outpatient visits and daily self-management tasks.
5. Kidney Health Mission: Facilitating daily recording of diet, medication intake, and physical activity through the extended App.
6. Inquiry \& Consultation: Providing common CKD-related Q\&A and consultation channels through interactive messages.
The use of the platform is not restricted by time or location, allowing CKD dyads to engage flexibly based on their needs or healthcare providers' instructions. Specifically, users are encouraged to engage daily with two main features, "Record Values" and "Kidney Health Mission," to document their lifestyle modification progress.
|
Control Group (Usual Care Only)
n=44 Participants
All study participants received regular checkups and treatments at the nephrology clinics of National Cheng Kung University Hospital. Nephrologists diagnosed and explained disease progression, treatment plans, prognosis, and risks based on clinical assessments. Care plans included medication adherence, home blood pressure monitoring, dietary adjustments, and regular physical activity. Participants also received nephrology nursing or nutritional counseling through the hospital's Health Education Center.
|
|---|---|---|
|
Change From Baseline in Health Promoting Lifestyle at 6 Months (Patient-specific)
|
-1.59 units on a scale
Standard Error 1.26
|
1.87 units on a scale
Standard Error 2.17
|
SECONDARY outcome
Timeframe: Before initial intervention and 6 months after initial interventionPopulation: For follow-up, 102 participants (51 patients + 51 significant others) from the intervention and 88 participants (44 patients and 44 significant others) from the control group completed the DAS-7 measure.
For each participant, change from Baseline (Followup score - Baseline score) in Dyadic Adjustment at 6 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.
Outcome measures
| Measure |
Intervention Group (Digital Dyadic Empowerment + Usual Care)
n=102 Participants
The intervention group (Digital Dyadic Empowerment + Usual Care) will use a platform based on LINE, a prominent instant messaging App in Taiwan. The platform is named "Kidney Lifestyle," consisted of a LINE Official Account (OA) and an extended App.
The primary objective of Digital Dyadic Empowerment is to encourage CKD dyads (patients and their significant others \[SOs\]) in modifying health-related lifestyles through the platform and instant messaging support. The main features include:
1. Health Education Information: Providing basic CKD management knowledge via interactive messages.
2. Kidney Support Teammate: Offering supportive resources for caregivers (significant others).
3. Record Values: Allowing users to track physiological measurements at home through the extended App.
4. Reminders Settings: Automatically sending messages to remind users of outpatient visits and daily self-management tasks.
5. Kidney Health Mission: Facilitating daily recording of diet, medication intake, and physical activity through the extended App.
6. Inquiry \& Consultation: Providing common CKD-related Q\&A and consultation channels through interactive messages.
The use of the platform is not restricted by time or location, allowing CKD dyads to engage flexibly based on their needs or healthcare providers' instructions. Specifically, users are encouraged to engage daily with two main features, "Record Values" and "Kidney Health Mission," to document their lifestyle modification progress.
|
Control Group (Usual Care Only)
n=88 Participants
All study participants received regular checkups and treatments at the nephrology clinics of National Cheng Kung University Hospital. Nephrologists diagnosed and explained disease progression, treatment plans, prognosis, and risks based on clinical assessments. Care plans included medication adherence, home blood pressure monitoring, dietary adjustments, and regular physical activity. Participants also received nephrology nursing or nutritional counseling through the hospital's Health Education Center.
|
|---|---|---|
|
Change From Baseline in Dyadic Adjustment at 6 Months
|
-0.43 units on a scale
Standard Error 0.62
|
-1.22 units on a scale
Standard Error 0.64
|
Adverse Events
Intervention Group (Digital Dyadic Empowerment + Usual Care)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Control Group (Usual Care Only)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intervention Group (Digital Dyadic Empowerment + Usual Care)
n=104 participants at risk
The intervention group (Digital Dyadic Empowerment + Usual Care) will use a platform based on LINE, a prominent instant messaging App in Taiwan. The platform is named "Kidney Lifestyle," consisted of a LINE Official Account (OA) and an extended App.
The primary objective of Digital Dyadic Empowerment is to encourage CKD dyads (patients and their significant others \[SOs\]) in modifying health-related lifestyles through the platform and instant messaging support. The main features include:
1. Health Education Information: Providing basic CKD management knowledge via interactive messages.
2. Kidney Support Teammate: Offering supportive resources for caregivers (significant others).
3. Record Values: Allowing users to track physiological measurements at home through the extended App.
4. Reminders Settings: Automatically sending messages to remind users of outpatient visits and daily self-management tasks.
5. Kidney Health Mission: Facilitating daily recording of diet, medication intake, and physical activity through the extended App.
6. Inquiry \& Consultation: Providing common CKD-related Q\&A and consultation channels through interactive messages.
The use of the platform is not restricted by time or location, allowing CKD dyads to engage flexibly based on their needs or healthcare providers' instructions. Specifically, users are encouraged to engage daily with two main features, "Record Values" and "Kidney Health Mission," to document their lifestyle modification progress.
|
Control Group (Usual Care Only)
n=104 participants at risk
All study participants received regular checkups and treatments at the nephrology clinics of National Cheng Kung University Hospital. Nephrologists diagnosed and explained disease progression, treatment plans, prognosis, and risks based on clinical assessments. Care plans included medication adherence, home blood pressure monitoring, dietary adjustments, and regular physical activity. Participants also received nephrology nursing or nutritional counseling through the hospital's Health Education Center.
|
|---|---|---|
|
General disorders
Self-reported medical visit (unrelated)
|
4.8%
5/104 • from enrollment until end of follow-up, ranging from 151 to 263 days (mean = 179 days, SD = 19.5).
Adverse events were captured by self-report from patients and significant others during in-person or remote (telephone/LINE) contacts throughout follow-up and recorded by research staff. Analyses include all randomized participants. Self-reported medical visits unrelated to the trial's \[digital\] intervention were documented during follow-up and were reported as general disorders under the 'other adverse events' category.
|
0.96%
1/104 • from enrollment until end of follow-up, ranging from 151 to 263 days (mean = 179 days, SD = 19.5).
Adverse events were captured by self-report from patients and significant others during in-person or remote (telephone/LINE) contacts throughout follow-up and recorded by research staff. Analyses include all randomized participants. Self-reported medical visits unrelated to the trial's \[digital\] intervention were documented during follow-up and were reported as general disorders under the 'other adverse events' category.
|
Additional Information
Chun-Yi Ho, Research Assistant
Department of Nursing, College of Medicine, 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