Chronic Kidney Diseases
Conditions
Keywords
feasibility studies, digital health, healthy lifestyle
Brief summary
This is a randomized controlled feasibility trial conducted on patients with Chronic Kidney Disease (CKD) and their significant other
Detailed description
The trial will be conducted on 60 dyads, each comprising a CKD patient and a significant other, who will be randomly assigned into two groups. The intervention group will receive the Digital Dyadic Empowerment Program (DDEP) while the control group will receive routine education and care.
Interventions
BEHAVIORALDigital 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.
Sponsors
National Health Research Institutes, Taiwan
National Cheng Kung University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The patient has a diagnosis of Chronic Kidney Disease for at least six months; 2. The patient can identify a helpful significant other and both parties are willing to participate; 3. The patient can communicate in Mandarin or Taiwanese.
Exclusion criteria
1. The significant other is a healthcare provider; 2. The patient or the significant other has a mental illness diagnosis; 3. The patient is currently receiving renal replacement therapies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Quality of Life at 3 Months | Before initial intervention and 3 months after initial intervention | 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. |
| Change From Baseline in CKD Stage at 3 Months (Patient-specific) | Before initial intervention and 3 months after initial intervention | 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 \[at follow-up\]). |
| Change From Baseline in TTM Stage at 3 Months | Before initial intervention and 3 months after initial intervention | 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 \[at follow-up\]). |
| Change From Baseline in Health Promoting Lifestyle at 3 Months (Patient-specific) | Before initial intervention and 3 months after initial intervention | 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. |
| Change From Baseline in eGFR at 3 Months (Patient-specific) | Before initial intervention and 3 months after initial intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Helping Relationships From Significant Others at 3 Months (Patient-specific) | Before initial intervention and 3 months after initial intervention | 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. |
| Change From Baseline in Dyadic Adjustment at 3 Months | Before initial intervention and 3 months after initial intervention | 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. |
| Change From Baseline in Adherence to Health Behaviors at 3 Months (Patient-specific) | Before initial intervention and 3 months after initial intervention | 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. |
Countries
Taiwan
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 51 |
| Control Group The control group receives routine education and care. | 58 |
| Total | 109 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 4 | 1 |
Baseline characteristics
| Characteristic | Total | Digital Dyadic Empowerment | Control Group |
|---|---|---|---|
| Adherence to Healthy Behaviors | 45.09 units on a scale STANDARD_DEVIATION 5.7 | 45.23 units on a scale STANDARD_DEVIATION 6 | 44.97 units on a scale STANDARD_DEVIATION 5.5 |
| Age, Continuous Patient | 68.73 years STANDARD_DEVIATION 12.49 | 68.69 years STANDARD_DEVIATION 10.45 | 68.76 years STANDARD_DEVIATION 14.26 |
| Age, Continuous Significant other | 53.85 years STANDARD_DEVIATION 15.24 | 51.56 years STANDARD_DEVIATION 14.51 | 55.83 years STANDARD_DEVIATION 15.82 |
| CKD Stage Stage 1 | 3 Participants | 2 Participants | 1 Participants |
| CKD Stage Stage 2 | 11 Participants | 4 Participants | 7 Participants |
| CKD Stage Stage 3a | 14 Participants | 8 Participants | 6 Participants |
| CKD Stage Stage 3b | 9 Participants | 5 Participants | 4 Participants |
| CKD Stage Stage 4 | 11 Participants | 5 Participants | 6 Participants |
| CKD Stage Stage 5 | 7 Participants | 2 Participants | 5 Participants |
| Dyadic Adjustment | 21.17 units on a scale STANDARD_DEVIATION 6.05 | 20.67 units on a scale STANDARD_DEVIATION 6.13 | 21.60 units on a scale STANDARD_DEVIATION 6 |
| eGFR | 45.84 ml/min/1.73m^2 STANDARD_DEVIATION 26.03 | 46.29 ml/min/1.73m^2 STANDARD_DEVIATION 21.65 | 45.43 ml/min/1.73m^2 STANDARD_DEVIATION 29.79 |
| Health Promoting Lifestyle | 141.40 units on a scale STANDARD_DEVIATION 23.04 | 142.19 units on a scale STANDARD_DEVIATION 24.8 | 140.69 units on a scale STANDARD_DEVIATION 21.7 |
| Helping Relationships from Significant Others | 89.56 units on a scale STANDARD_DEVIATION 15.1 | 88.58 units on a scale STANDARD_DEVIATION 18.2 | 90.45 units on a scale STANDARD_DEVIATION 12 |
| Quality of Life | 3.61 units on a scale STANDARD_DEVIATION 0.69 | 3.61 units on a scale STANDARD_DEVIATION 0.7 | 3.60 units on a scale STANDARD_DEVIATION 0.7 |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Region of Enrollment Taiwan | 109 Participants | 51 Participants | 58 Participants |
| Sex: Female, Male Patient Female | 22 Participants | 13 Participants | 9 Participants |
| Sex: Female, Male Patient Male | 33 Participants | 13 Participants | 20 Participants |
| Sex: Female, Male Significant other Female | 38 Participants | 16 Participants | 22 Participants |
| Sex: Female, Male Significant other Male | 16 Participants | 9 Participants | 7 Participants |
| TTM Stage Action | 14 dyad | 7 dyad | 7 dyad |
| TTM Stage Contemplation | 1 dyad | 0 dyad | 1 dyad |
| TTM Stage Maintenance | 31 dyad | 12 dyad | 19 dyad |
| TTM Stage Precontemplation | 3 dyad | 2 dyad | 1 dyad |
| TTM Stage Preparation | 6 dyad | 5 dyad | 1 dyad |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 60 |
| other Total, other adverse events | 0 / 60 | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
Primary
Change From Baseline in CKD Stage at 3 Months (Patient-specific)
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 \[at follow-up\]).
Time frame: Before initial intervention and 3 months after initial intervention
Population: This measure was conducted only on the patient participants.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Digital Dyadic Empowerment | Change From Baseline in CKD Stage at 3 Months (Patient-specific) | Recover | 2 Participants |
| Digital Dyadic Empowerment | Change From Baseline in CKD Stage at 3 Months (Patient-specific) | Stable | 18 Participants |
| Digital Dyadic Empowerment | Change From Baseline in CKD Stage at 3 Months (Patient-specific) | Progress | 6 Participants |
| Control Group | Change From Baseline in CKD Stage at 3 Months (Patient-specific) | Recover | 4 Participants |
| Control Group | Change From Baseline in CKD Stage at 3 Months (Patient-specific) | Stable | 20 Participants |
| Control Group | Change From Baseline in CKD Stage at 3 Months (Patient-specific) | Progress | 5 Participants |
Primary
Change From Baseline in eGFR at 3 Months (Patient-specific)
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.
Time frame: Before initial intervention and 3 months after initial intervention
Population: The test of eGFR was conducted only on patient participants.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Digital Dyadic Empowerment | Change From Baseline in eGFR at 3 Months (Patient-specific) | -1.71 ml/min/1.73m^2 |
| Control Group | Change From Baseline in eGFR at 3 Months (Patient-specific) | -4.12 ml/min/1.73m^2 |
Primary
Change From Baseline in Health Promoting Lifestyle at 3 Months (Patient-specific)
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.
Time frame: Before initial intervention and 3 months after initial intervention
Population: This questionnaire was only administrated to the patient participants.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Digital Dyadic Empowerment | Change From Baseline in Health Promoting Lifestyle at 3 Months (Patient-specific) | 5.96 score on a scale |
| Control Group | Change From Baseline in Health Promoting Lifestyle at 3 Months (Patient-specific) | -8.17 score on a scale |
Primary
Change From Baseline in Quality of Life at 3 Months
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.
Time frame: Before initial intervention and 3 months after initial intervention
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Digital Dyadic Empowerment | Change From Baseline in Quality of Life at 3 Months | -0.02 units on a scale |
| Control Group | Change From Baseline in Quality of Life at 3 Months | -0.16 units on a scale |
Primary
Change From Baseline in TTM Stage at 3 Months
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 \[at follow-up\]).
Time frame: Before initial intervention and 3 months after initial intervention
Population: This measure was reported jointly by the patient and the significant other within each dyad.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Digital Dyadic Empowerment | Change From Baseline in TTM Stage at 3 Months | Maintain | 14 dyad |
| Digital Dyadic Empowerment | Change From Baseline in TTM Stage at 3 Months | Regress | 4 dyad |
| Digital Dyadic Empowerment | Change From Baseline in TTM Stage at 3 Months | Advance | 8 dyad |
| Control Group | Change From Baseline in TTM Stage at 3 Months | Regress | 5 dyad |
| Control Group | Change From Baseline in TTM Stage at 3 Months | Maintain | 19 dyad |
| Control Group | Change From Baseline in TTM Stage at 3 Months | Advance | 5 dyad |
Secondary
Change From Baseline in Adherence to Health Behaviors at 3 Months (Patient-specific)
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.
Time frame: Before initial intervention and 3 months after initial intervention
Population: This questionnaire was only administrated to the patient participants.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Digital Dyadic Empowerment | Change From Baseline in Adherence to Health Behaviors at 3 Months (Patient-specific) | 1.81 score on a scale |
| Control Group | Change From Baseline in Adherence to Health Behaviors at 3 Months (Patient-specific) | 0.10 score on a scale |
Secondary
Change From Baseline in Dyadic Adjustment at 3 Months
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.
Time frame: Before initial intervention and 3 months after initial intervention
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Digital Dyadic Empowerment | Change From Baseline in Dyadic Adjustment at 3 Months | 2.49 score on a scale |
| Control Group | Change From Baseline in Dyadic Adjustment at 3 Months | -1.47 score on a scale |
Secondary
Change From Baseline in Helping Relationships From Significant Others at 3 Months (Patient-specific)
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.
Time frame: Before initial intervention and 3 months after initial intervention
Population: This questionnaire was only administrated to the patient participants.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Digital Dyadic Empowerment | Change From Baseline in Helping Relationships From Significant Others at 3 Months (Patient-specific) | 4.42 score on a scale |
| Control Group | Change From Baseline in Helping Relationships From Significant Others at 3 Months (Patient-specific) | -8.86 score on a scale |