Trial Outcomes & Findings for DDEP for Lifestyle Modification in Chronic Kidney Disease (NCT NCT06226649)
NCT ID: NCT06226649
Last Updated: 2025-05-02
Results Overview
For each patient, change from Baseline (Followup score - Baseline score) in the estimated Glomerular Filtration Rate (eGFR) by the IDMS-MDRD Equation at 3 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
120 participants
Primary outcome timeframe
Before initial intervention and 3 months after initial intervention
Results posted on
2025-05-02
Participant Flow
The "Enrollment" number (i.e., 120) in the Study Design Section reflects the total number of \*participants\* enrolled, and the number "Started" (i.e., 60) in the Participant Flow reflects the number of \*dyads\* assigned to Arms/Groups.
Participant milestones
| Measure |
Digital Dyadic Empowerment
The intervention group (Digital Dyadic Empowerment) will utilize LINE, a prominent instant messaging App in Taiwan, to assist in lifestyle modification, along with support from the significant other.
Digital Dyadic Empowerment: The Digital Dyadic Empowerment Intervention utilizes LINE, a prominent instant messaging App in Taiwan, integrated with an extended application to deliver comprehensive lifestyle modification support to Chronic Kidney Disease (CKD) dyads. Key features of this intervention include:
1. Access to CKD Health Education Information;
2. Supportive Information for Significant Others;
3. Physiological Values Logging for Self-Monitoring;
4. Reminders for Clinical Appointments and Daily Self-Management Tasks;
5. Kidney Health Diary for Lifestyle Modification Progress Tracking;
6. Frequently Asked Questions (FAQs) and Consultation with Healthcare Providers.
This intervention aims to enhance the overall well-being of CKD dyads by promoting education, self-monitoring, adherence to appointments, and efficient communication with healthcare providers.
|
Control Group
The control group receives routine education and care.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
26
|
29
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
Digital Dyadic Empowerment
The intervention group (Digital Dyadic Empowerment) will utilize LINE, a prominent instant messaging App in Taiwan, to assist in lifestyle modification, along with support from the significant other.
Digital Dyadic Empowerment: The Digital Dyadic Empowerment Intervention utilizes LINE, a prominent instant messaging App in Taiwan, integrated with an extended application to deliver comprehensive lifestyle modification support to Chronic Kidney Disease (CKD) dyads. Key features of this intervention include:
1. Access to CKD Health Education Information;
2. Supportive Information for Significant Others;
3. Physiological Values Logging for Self-Monitoring;
4. Reminders for Clinical Appointments and Daily Self-Management Tasks;
5. Kidney Health Diary for Lifestyle Modification Progress Tracking;
6. Frequently Asked Questions (FAQs) and Consultation with Healthcare Providers.
This intervention aims to enhance the overall well-being of CKD dyads by promoting education, self-monitoring, adherence to appointments, and efficient communication with healthcare providers.
|
Control Group
The control group receives routine education and care.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
Baseline Characteristics
All 109 participants completed the baseline measure of Age. However, the age of the significant other or 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, this measure reported here includes patient only to reflect the distribution of patient's age.
Baseline characteristics by cohort
| Measure |
Digital Dyadic Empowerment
n=51 Participants
The intervention group (Digital Dyadic Empowerment) will utilize LINE, a prominent instant messaging App in Taiwan, to assist in lifestyle modification, along with support from the significant other.
Digital Dyadic Empowerment: The Digital Dyadic Empowerment Intervention utilizes LINE, a prominent instant messaging App in Taiwan, integrated with an extended application to deliver comprehensive lifestyle modification support to Chronic Kidney Disease (CKD) dyads. Key features of this intervention include:
1. Access to CKD Health Education Information;
2. Supportive Information for Significant Others;
3. Physiological Values Logging for Self-Monitoring;
4. Reminders for Clinical Appointments and Daily Self-Management Tasks;
5. Kidney Health Diary for Lifestyle Modification Progress Tracking;
6. Frequently Asked Questions (FAQs) and Consultation with Healthcare Providers.
This intervention aims to enhance the overall well-being of CKD dyads by promoting education, self-monitoring, adherence to appointments, and efficient communication with healthcare providers.
|
Control Group
n=58 Participants
The control group receives routine education and care.
|
Total
n=109 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Patient
|
68.69 years
STANDARD_DEVIATION 10.45 • n=26 Participants • All 109 participants completed the baseline measure of Age. However, the age of the significant other or 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, this measure reported here includes patient only to reflect the distribution of patient's age.
|
68.76 years
STANDARD_DEVIATION 14.26 • n=29 Participants • All 109 participants completed the baseline measure of Age. However, the age of the significant other or 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, this measure reported here includes patient only to reflect the distribution of patient's age.
|
68.73 years
STANDARD_DEVIATION 12.49 • n=55 Participants • All 109 participants completed the baseline measure of Age. However, the age of the significant other or 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, this measure reported here includes patient only to reflect the distribution of patient's age.
|
|
Age, Continuous
Significant other
|
51.56 years
STANDARD_DEVIATION 14.51 • n=25 Participants • All 109 participants completed the baseline measure of Age. However, the age of the significant other or 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, this measure reported here includes patient only to reflect the distribution of patient's age.
|
55.83 years
STANDARD_DEVIATION 15.82 • n=29 Participants • All 109 participants completed the baseline measure of Age. However, the age of the significant other or 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, this measure reported here includes patient only to reflect the distribution of patient's age.
|
53.85 years
STANDARD_DEVIATION 15.24 • n=54 Participants • All 109 participants completed the baseline measure of Age. However, the age of the significant other or 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, this measure reported here includes patient only to reflect the distribution of patient's age.
|
|
Sex: Female, Male
Patient · Female
|
13 Participants
n=26 Participants • All 109 participants completed the baseline measure of Sex. However, the count of sex for significant others or 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, this measure reported here includes patient only.
|
9 Participants
n=29 Participants • All 109 participants completed the baseline measure of Sex. However, the count of sex for significant others or 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, this measure reported here includes patient only.
|
22 Participants
n=55 Participants • All 109 participants completed the baseline measure of Sex. However, the count of sex for significant others or 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, this measure reported here includes patient only.
|
|
Sex: Female, Male
Patient · Male
|
13 Participants
n=26 Participants • All 109 participants completed the baseline measure of Sex. However, the count of sex for significant others or 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, this measure reported here includes patient only.
|
20 Participants
n=29 Participants • All 109 participants completed the baseline measure of Sex. However, the count of sex for significant others or 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, this measure reported here includes patient only.
|
33 Participants
n=55 Participants • All 109 participants completed the baseline measure of Sex. However, the count of sex for significant others or 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, this measure reported here includes patient only.
|
|
Sex: Female, Male
Significant other · Female
|
16 Participants
n=25 Participants • All 109 participants completed the baseline measure of Sex. However, the count of sex for significant others or 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, this measure reported here includes patient only.
|
22 Participants
n=29 Participants • All 109 participants completed the baseline measure of Sex. However, the count of sex for significant others or 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, this measure reported here includes patient only.
|
38 Participants
n=54 Participants • All 109 participants completed the baseline measure of Sex. However, the count of sex for significant others or 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, this measure reported here includes patient only.
|
|
Sex: Female, Male
Significant other · Male
|
9 Participants
n=25 Participants • All 109 participants completed the baseline measure of Sex. However, the count of sex for significant others or 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, this measure reported here includes patient only.
|
7 Participants
n=29 Participants • All 109 participants completed the baseline measure of Sex. However, the count of sex for significant others or 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, this measure reported here includes patient only.
|
16 Participants
n=54 Participants • All 109 participants completed the baseline measure of Sex. However, the count of sex for significant others or 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, this measure reported here includes patient only.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Taiwan
|
51 Participants
n=51 Participants
|
58 Participants
n=58 Participants
|
109 Participants
n=109 Participants
|
|
eGFR
|
46.29 ml/min/1.73m^2
STANDARD_DEVIATION 21.65 • n=26 Participants • This measure includes patient only.
|
45.43 ml/min/1.73m^2
STANDARD_DEVIATION 29.79 • n=29 Participants • This measure includes patient only.
|
45.84 ml/min/1.73m^2
STANDARD_DEVIATION 26.03 • n=55 Participants • This measure includes patient only.
|
|
CKD Stage
Stage 1
|
2 Participants
n=26 Participants • This measure includes patient only.
|
1 Participants
n=29 Participants • This measure includes patient only.
|
3 Participants
n=55 Participants • This measure includes patient only.
|
|
CKD Stage
Stage 2
|
4 Participants
n=26 Participants • This measure includes patient only.
|
7 Participants
n=29 Participants • This measure includes patient only.
|
11 Participants
n=55 Participants • This measure includes patient only.
|
|
CKD Stage
Stage 3a
|
8 Participants
n=26 Participants • This measure includes patient only.
|
6 Participants
n=29 Participants • This measure includes patient only.
|
14 Participants
n=55 Participants • This measure includes patient only.
|
|
CKD Stage
Stage 3b
|
5 Participants
n=26 Participants • This measure includes patient only.
|
4 Participants
n=29 Participants • This measure includes patient only.
|
9 Participants
n=55 Participants • This measure includes patient only.
|
|
CKD Stage
Stage 4
|
5 Participants
n=26 Participants • This measure includes patient only.
|
6 Participants
n=29 Participants • This measure includes patient only.
|
11 Participants
n=55 Participants • This measure includes patient only.
|
|
CKD Stage
Stage 5
|
2 Participants
n=26 Participants • This measure includes patient only.
|
5 Participants
n=29 Participants • This measure includes patient only.
|
7 Participants
n=55 Participants • This measure includes patient only.
|
|
TTM Stage
Precontemplation
|
2 dyad
n=51 Participants • This measure was reported jointly by the patient and the significant other within each dyad.
|
1 dyad
n=58 Participants • This measure was reported jointly by the patient and the significant other within each dyad.
|
3 dyad
n=109 Participants • This measure was reported jointly by the patient and the significant other within each dyad.
|
|
TTM Stage
Contemplation
|
0 dyad
n=51 Participants • This measure was reported jointly by the patient and the significant other within each dyad.
|
1 dyad
n=58 Participants • This measure was reported jointly by the patient and the significant other within each dyad.
|
1 dyad
n=109 Participants • This measure was reported jointly by the patient and the significant other within each dyad.
|
|
TTM Stage
Preparation
|
5 dyad
n=51 Participants • This measure was reported jointly by the patient and the significant other within each dyad.
|
1 dyad
n=58 Participants • This measure was reported jointly by the patient and the significant other within each dyad.
|
6 dyad
n=109 Participants • This measure was reported jointly by the patient and the significant other within each dyad.
|
|
TTM Stage
Action
|
7 dyad
n=51 Participants • This measure was reported jointly by the patient and the significant other within each dyad.
|
7 dyad
n=58 Participants • This measure was reported jointly by the patient and the significant other within each dyad.
|
14 dyad
n=109 Participants • This measure was reported jointly by the patient and the significant other within each dyad.
|
|
TTM Stage
Maintenance
|
12 dyad
n=51 Participants • This measure was reported jointly by the patient and the significant other within each dyad.
|
19 dyad
n=58 Participants • This measure was reported jointly by the patient and the significant other within each dyad.
|
31 dyad
n=109 Participants • This measure was reported jointly by the patient and the significant other within each dyad.
|
|
Health Promoting Lifestyle
|
142.19 units on a scale
STANDARD_DEVIATION 24.8 • n=26 Participants • This measure includes patients only.
|
140.69 units on a scale
STANDARD_DEVIATION 21.7 • n=29 Participants • This measure includes patients only.
|
141.40 units on a scale
STANDARD_DEVIATION 23.04 • n=55 Participants • This measure includes patients only.
|
|
Adherence to Healthy Behaviors
|
45.23 units on a scale
STANDARD_DEVIATION 6.0 • n=26 Participants • This measure includes patient only.
|
44.97 units on a scale
STANDARD_DEVIATION 5.5 • n=29 Participants • This measure includes patient only.
|
45.09 units on a scale
STANDARD_DEVIATION 5.7 • n=55 Participants • This measure includes patient only.
|
|
Helping Relationships from Significant Others
|
88.58 units on a scale
STANDARD_DEVIATION 18.2 • n=26 Participants • This measure includes patient only.
|
90.45 units on a scale
STANDARD_DEVIATION 12.0 • n=29 Participants • This measure includes patient only.
|
89.56 units on a scale
STANDARD_DEVIATION 15.1 • n=55 Participants • This measure includes patient only.
|
|
Dyadic Adjustment
|
20.67 units on a scale
STANDARD_DEVIATION 6.13 • n=51 Participants • This scale was measured for both patients and their significant others. Specifically, 26 dyads from the intervention group and 29 dyads from the control group completed the baseline assessment for this scale. However, one significant other from the intervention did not complete the baseline assessment for this scale. As a result, 51 (26\*2-1) participants from the intervention group and 58 (29\*2) participants from the control group were included for the analysis population of this scale.
|
21.60 units on a scale
STANDARD_DEVIATION 6.00 • n=58 Participants • This scale was measured for both patients and their significant others. Specifically, 26 dyads from the intervention group and 29 dyads from the control group completed the baseline assessment for this scale. However, one significant other from the intervention did not complete the baseline assessment for this scale. As a result, 51 (26\*2-1) participants from the intervention group and 58 (29\*2) participants from the control group were included for the analysis population of this scale.
|
21.17 units on a scale
STANDARD_DEVIATION 6.05 • n=109 Participants • This scale was measured for both patients and their significant others. Specifically, 26 dyads from the intervention group and 29 dyads from the control group completed the baseline assessment for this scale. However, one significant other from the intervention did not complete the baseline assessment for this scale. As a result, 51 (26\*2-1) participants from the intervention group and 58 (29\*2) participants from the control group were included for the analysis population of this scale.
|
|
Quality of Life
|
3.61 units on a scale
STANDARD_DEVIATION 0.70 • n=51 Participants
|
3.60 units on a scale
STANDARD_DEVIATION 0.70 • n=58 Participants
|
3.61 units on a scale
STANDARD_DEVIATION 0.69 • n=109 Participants
|
PRIMARY outcome
Timeframe: Before initial intervention and 3 months after initial interventionPopulation: The test of eGFR was conducted only on patient participants.
For each patient, change from Baseline (Followup score - Baseline score) in the estimated Glomerular Filtration Rate (eGFR) by the IDMS-MDRD Equation at 3 months was obtained through the patient's biochemical test reports. Higher eGFR numbers generally indicate better kidney functions.
Outcome measures
| Measure |
Digital Dyadic Empowerment
n=26 Participants
The intervention group (Digital Dyadic Empowerment) will utilize LINE, a prominent instant messaging App in Taiwan, to assist in lifestyle modification, along with support from the significant other.
Digital Dyadic Empowerment: The Digital Dyadic Empowerment Intervention utilizes LINE, a prominent instant messaging App in Taiwan, integrated with an extended application to deliver comprehensive lifestyle modification support to Chronic Kidney Disease (CKD) dyads. Key features of this intervention include:
1. Access to CKD Health Education Information;
2. Supportive Information for Significant Others;
3. Physiological Values Logging for Self-Monitoring;
4. Reminders for Clinical Appointments and Daily Self-Management Tasks;
5. Kidney Health Diary for Lifestyle Modification Progress Tracking;
6. Frequently Asked Questions (FAQs) and Consultation with Healthcare Providers.
This intervention aims to enhance the overall well-being of CKD dyads by promoting education, self-monitoring, adherence to appointments, and efficient communication with healthcare providers.
|
Control Group
n=29 Participants
The control group receives routine education and care.
|
|---|---|---|
|
Change From Baseline in eGFR at 3 Months (Patient-specific)
|
-1.71 ml/min/1.73m^2
Interval -3.58 to 0.17
|
-4.12 ml/min/1.73m^2
Interval -9.11 to 0.86
|
PRIMARY outcome
Timeframe: Before initial intervention and 3 months after initial interventionPopulation: This measure was conducted only on the patient participants.
For each patient, the change from Baseline in CKD stage at 3 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 |
Digital Dyadic Empowerment
n=26 Participants
The intervention group (Digital Dyadic Empowerment) will utilize LINE, a prominent instant messaging App in Taiwan, to assist in lifestyle modification, along with support from the significant other.
Digital Dyadic Empowerment: The Digital Dyadic Empowerment Intervention utilizes LINE, a prominent instant messaging App in Taiwan, integrated with an extended application to deliver comprehensive lifestyle modification support to Chronic Kidney Disease (CKD) dyads. Key features of this intervention include:
1. Access to CKD Health Education Information;
2. Supportive Information for Significant Others;
3. Physiological Values Logging for Self-Monitoring;
4. Reminders for Clinical Appointments and Daily Self-Management Tasks;
5. Kidney Health Diary for Lifestyle Modification Progress Tracking;
6. Frequently Asked Questions (FAQs) and Consultation with Healthcare Providers.
This intervention aims to enhance the overall well-being of CKD dyads by promoting education, self-monitoring, adherence to appointments, and efficient communication with healthcare providers.
|
Control Group
n=29 Participants
The control group receives routine education and care.
|
|---|---|---|
|
Change From Baseline in CKD Stage at 3 Months (Patient-specific)
Recover
|
2 Participants
|
4 Participants
|
|
Change From Baseline in CKD Stage at 3 Months (Patient-specific)
Stable
|
18 Participants
|
20 Participants
|
|
Change From Baseline in CKD Stage at 3 Months (Patient-specific)
Progress
|
6 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Before initial intervention and 3 months after initial interventionPopulation: This measure was reported jointly by the patient and the significant other within each dyad.
For each dyad, change from Baseline in TTM stage at 3 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 Maintanece \[at follow-up\]).
Outcome measures
| Measure |
Digital Dyadic Empowerment
n=51 Participants
The intervention group (Digital Dyadic Empowerment) will utilize LINE, a prominent instant messaging App in Taiwan, to assist in lifestyle modification, along with support from the significant other.
Digital Dyadic Empowerment: The Digital Dyadic Empowerment Intervention utilizes LINE, a prominent instant messaging App in Taiwan, integrated with an extended application to deliver comprehensive lifestyle modification support to Chronic Kidney Disease (CKD) dyads. Key features of this intervention include:
1. Access to CKD Health Education Information;
2. Supportive Information for Significant Others;
3. Physiological Values Logging for Self-Monitoring;
4. Reminders for Clinical Appointments and Daily Self-Management Tasks;
5. Kidney Health Diary for Lifestyle Modification Progress Tracking;
6. Frequently Asked Questions (FAQs) and Consultation with Healthcare Providers.
This intervention aims to enhance the overall well-being of CKD dyads by promoting education, self-monitoring, adherence to appointments, and efficient communication with healthcare providers.
|
Control Group
n=58 Participants
The control group receives routine education and care.
|
|---|---|---|
|
Change From Baseline in TTM Stage at 3 Months
Regress
|
4 dyad
|
5 dyad
|
|
Change From Baseline in TTM Stage at 3 Months
Maintain
|
14 dyad
|
19 dyad
|
|
Change From Baseline in TTM Stage at 3 Months
Advance
|
8 dyad
|
5 dyad
|
PRIMARY outcome
Timeframe: Before initial intervention and 3 months after initial interventionPopulation: This questionnaire was only administrated to the patient participants.
For each patient, change from Baseline (Followup score - Baseline score) in patient's Health Promoting Lifestyle at 3 months was assessed using the Chinese version of the Health Promoting Lifestyle Profile-II (HPLP-II), a validated scale with 52 items rated on a 4-point Likert scale. The total scores range from 52 to 208, with higher scores indicate better health-promoting behavior.
Outcome measures
| Measure |
Digital Dyadic Empowerment
n=26 Participants
The intervention group (Digital Dyadic Empowerment) will utilize LINE, a prominent instant messaging App in Taiwan, to assist in lifestyle modification, along with support from the significant other.
Digital Dyadic Empowerment: The Digital Dyadic Empowerment Intervention utilizes LINE, a prominent instant messaging App in Taiwan, integrated with an extended application to deliver comprehensive lifestyle modification support to Chronic Kidney Disease (CKD) dyads. Key features of this intervention include:
1. Access to CKD Health Education Information;
2. Supportive Information for Significant Others;
3. Physiological Values Logging for Self-Monitoring;
4. Reminders for Clinical Appointments and Daily Self-Management Tasks;
5. Kidney Health Diary for Lifestyle Modification Progress Tracking;
6. Frequently Asked Questions (FAQs) and Consultation with Healthcare Providers.
This intervention aims to enhance the overall well-being of CKD dyads by promoting education, self-monitoring, adherence to appointments, and efficient communication with healthcare providers.
|
Control Group
n=29 Participants
The control group receives routine education and care.
|
|---|---|---|
|
Change From Baseline in Health Promoting Lifestyle at 3 Months (Patient-specific)
|
5.96 score on a scale
Interval -0.77 to 12.7
|
-8.17 score on a scale
Interval -18.52 to 2.18
|
PRIMARY outcome
Timeframe: Before initial intervention and 3 months after initial interventionPopulation: This scale was measured for both patients and their significant others. Specifically, 26 dyads from the intervention group and 29 dyads from the control group completed the baseline assessment for this scale. However, one significant other from the intervention did not complete the baseline assessment for this scale. As a result, 51 (26\*2-1) participants from the intervention group and 58 (29\*2) participants from the control group were included for the analysis population of this scale.
For each participant, change from Baseline (Followup score - Baseline score) in Quality of Life at 3 months was assessed using the first item of the Taiwanese version of the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF). The item was rated on a 5-point Likert scale, ranging from 1 to 5. Higher scores indicate better quality of life.
Outcome measures
| Measure |
Digital Dyadic Empowerment
n=51 Participants
The intervention group (Digital Dyadic Empowerment) will utilize LINE, a prominent instant messaging App in Taiwan, to assist in lifestyle modification, along with support from the significant other.
Digital Dyadic Empowerment: The Digital Dyadic Empowerment Intervention utilizes LINE, a prominent instant messaging App in Taiwan, integrated with an extended application to deliver comprehensive lifestyle modification support to Chronic Kidney Disease (CKD) dyads. Key features of this intervention include:
1. Access to CKD Health Education Information;
2. Supportive Information for Significant Others;
3. Physiological Values Logging for Self-Monitoring;
4. Reminders for Clinical Appointments and Daily Self-Management Tasks;
5. Kidney Health Diary for Lifestyle Modification Progress Tracking;
6. Frequently Asked Questions (FAQs) and Consultation with Healthcare Providers.
This intervention aims to enhance the overall well-being of CKD dyads by promoting education, self-monitoring, adherence to appointments, and efficient communication with healthcare providers.
|
Control Group
n=58 Participants
The control group receives routine education and care.
|
|---|---|---|
|
Change From Baseline in Quality of Life at 3 Months
|
-0.02 units on a scale
Interval -0.21 to 0.17
|
-0.16 units on a scale
Interval -0.4 to 0.09
|
SECONDARY outcome
Timeframe: Before initial intervention and 3 months after initial interventionPopulation: This questionnaire was only administrated to the patient participants.
For each patient, change from Baseline (Followup score - Baseline score) in patient's adherence to healthy behaviors was measured using the Adherence to Healthy Behaviors Scale (AHBS). The scale includes 13 items rated on a 5-point Likert scale, with total scores ranging from 0 to 52. Higher scores indicate better adherence.
Outcome measures
| Measure |
Digital Dyadic Empowerment
n=26 Participants
The intervention group (Digital Dyadic Empowerment) will utilize LINE, a prominent instant messaging App in Taiwan, to assist in lifestyle modification, along with support from the significant other.
Digital Dyadic Empowerment: The Digital Dyadic Empowerment Intervention utilizes LINE, a prominent instant messaging App in Taiwan, integrated with an extended application to deliver comprehensive lifestyle modification support to Chronic Kidney Disease (CKD) dyads. Key features of this intervention include:
1. Access to CKD Health Education Information;
2. Supportive Information for Significant Others;
3. Physiological Values Logging for Self-Monitoring;
4. Reminders for Clinical Appointments and Daily Self-Management Tasks;
5. Kidney Health Diary for Lifestyle Modification Progress Tracking;
6. Frequently Asked Questions (FAQs) and Consultation with Healthcare Providers.
This intervention aims to enhance the overall well-being of CKD dyads by promoting education, self-monitoring, adherence to appointments, and efficient communication with healthcare providers.
|
Control Group
n=29 Participants
The control group receives routine education and care.
|
|---|---|---|
|
Change From Baseline in Adherence to Health Behaviors at 3 Months (Patient-specific)
|
1.81 score on a scale
Interval 0.17 to 3.45
|
0.10 score on a scale
Interval -2.33 to 2.54
|
SECONDARY outcome
Timeframe: Before initial intervention and 3 months after initial interventionPopulation: This questionnaire was only administrated to the patient participants.
For each patient, change from Baseline (Followup score - Baseline score) in patient's Helping Relationships from Significant Others at 3 months was assessed using the Chinese version of the Helping Relationships from Significant Others Scale (HRSO).The scale consists of 15 items rated on a 7-point Likert scale, with total scores ranging from 15 to 105. Higher scores indicate better support from the significant other.
Outcome measures
| Measure |
Digital Dyadic Empowerment
n=26 Participants
The intervention group (Digital Dyadic Empowerment) will utilize LINE, a prominent instant messaging App in Taiwan, to assist in lifestyle modification, along with support from the significant other.
Digital Dyadic Empowerment: The Digital Dyadic Empowerment Intervention utilizes LINE, a prominent instant messaging App in Taiwan, integrated with an extended application to deliver comprehensive lifestyle modification support to Chronic Kidney Disease (CKD) dyads. Key features of this intervention include:
1. Access to CKD Health Education Information;
2. Supportive Information for Significant Others;
3. Physiological Values Logging for Self-Monitoring;
4. Reminders for Clinical Appointments and Daily Self-Management Tasks;
5. Kidney Health Diary for Lifestyle Modification Progress Tracking;
6. Frequently Asked Questions (FAQs) and Consultation with Healthcare Providers.
This intervention aims to enhance the overall well-being of CKD dyads by promoting education, self-monitoring, adherence to appointments, and efficient communication with healthcare providers.
|
Control Group
n=29 Participants
The control group receives routine education and care.
|
|---|---|---|
|
Change From Baseline in Helping Relationships From Significant Others at 3 Months (Patient-specific)
|
4.42 score on a scale
Interval -0.9 to 9.75
|
-8.86 score on a scale
Interval -15.34 to -2.39
|
SECONDARY outcome
Timeframe: Before initial intervention and 3 months after initial interventionPopulation: This scale was measured for both patients and their significant others. Specifically, 26 dyads from the intervention group and 29 dyads from the control group completed the baseline assessment for this scale. However, one significant other from the intervention did not complete the baseline assessment for this scale. As a result, 51 (26\*2-1) participants from the intervention group and 58 (29\*2) participants from the control group were included for the analysis population of this scale.
For each participant, change from Baseline (Followup score - Baseline score) in Dyadic Adjustment at 3 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 |
Digital Dyadic Empowerment
n=51 Participants
The intervention group (Digital Dyadic Empowerment) will utilize LINE, a prominent instant messaging App in Taiwan, to assist in lifestyle modification, along with support from the significant other.
Digital Dyadic Empowerment: The Digital Dyadic Empowerment Intervention utilizes LINE, a prominent instant messaging App in Taiwan, integrated with an extended application to deliver comprehensive lifestyle modification support to Chronic Kidney Disease (CKD) dyads. Key features of this intervention include:
1. Access to CKD Health Education Information;
2. Supportive Information for Significant Others;
3. Physiological Values Logging for Self-Monitoring;
4. Reminders for Clinical Appointments and Daily Self-Management Tasks;
5. Kidney Health Diary for Lifestyle Modification Progress Tracking;
6. Frequently Asked Questions (FAQs) and Consultation with Healthcare Providers.
This intervention aims to enhance the overall well-being of CKD dyads by promoting education, self-monitoring, adherence to appointments, and efficient communication with healthcare providers.
|
Control Group
n=58 Participants
The control group receives routine education and care.
|
|---|---|---|
|
Change From Baseline in Dyadic Adjustment at 3 Months
|
2.49 score on a scale
Interval 0.15 to 4.83
|
-1.47 score on a scale
Interval -3.12 to 0.19
|
Adverse Events
Digital Dyadic Empowerment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place