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| Name | Class |
|---|---|
| National Health Research Institutes, Taiwan | OTHER |
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This is a randomized controlled feasibility trial conducted on patients with Chronic Kidney Disease (CKD) and their significant other
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital Dyadic Empowerment | Experimental | 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. |
|
| Control group | No Intervention | The control group receives routine education and care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Dyadic Empowerment | Behavioral | 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:
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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Before initial intervention and 3 months after initial intervention |
| 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]). | Before initial intervention and 3 months after initial intervention |
| 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]). | Before initial intervention and 3 months after initial intervention |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Miaofen Yen, PhD | National Cheng Kung University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cheng Kung University | Tainan | 70101 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42205542 | Derived | Ho CY, Siregar D, Lin WH, Sung JM, Wang MC, Yen M. Dyadic mobile intervention empowering lifestyle modification in chronic kidney disease management: A feasibility randomized controlled trial. Int J Nurs Stud Adv. 2026 May 14;10:100549. doi: 10.1016/j.ijnsa.2026.100549. eCollection 2026 Jun. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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:
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. |
| FG001 | Control Group | The control group receives routine education and care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
Baseline data were not collected for those participants who dropped out of the study. Specifically, 4 dyads + 1 significant other in the intervention group and 1 dyad in the control group dropped out. As a result, there are 51 ([30-4]*2-1) participants from the intervention group and 58 ([30-1]*2) participants from the control group for baseline assessment. The overall number of baseline participants is therefore 109.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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:
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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 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. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The test of eGFR was conducted only on patient participants. | Posted | Mean | 95% Confidence Interval | ml/min/1.73m^2 | Before initial intervention and 3 months after initial intervention |
|
9 months
For this study, adverse events are defined as any discomfort reported by all participants from using the DDEP platform for the intervention group, or from completing questionnaires for all participants for both the intervention or the control groups.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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:
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. |
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Since this is a feasibility trial, the change from baseline estimates for all outcomes were underpowered, and therefore 95% confidence intervals (CIs) were reported instead.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mr. Chun-Yi Ho | National Cheng Kung University | 886-6-2353535 | 5852 | eggman0011@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 4, 2023 | Feb 5, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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|
| Before initial intervention and 3 months after initial intervention |
| 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. | Before initial intervention and 3 months after initial intervention |
| Before initial intervention and 3 months after initial intervention |
| 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. | Before initial intervention and 3 months after initial intervention |
| 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. | Before initial intervention and 3 months after initial intervention |
| BG001 | Control Group | The control group receives routine education and care. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | 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. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| eGFR | Estimated Glomerular Filtration Rate (eGFR) by the IDMS-MDRD Equation | This measure includes patient only. | Mean | Standard Deviation | ml/min/1.73m^2 |
|
| CKD Stage | A patient's stage of chronic kidney disease (CKD) based on eGFR. Criteria: Stage 1 (eGFR 90 or above), Stage 2 (eGFR 60-89), Stage 3a (eGFR 45-59), Stage 3b (eGFR 30-44), Stage 4 (eGFR 15-29), Stage 5 (eGFR less than 15). Higher stages (Stage 3b, Stage 4, and Stage 5) represent more advanced and severe progression of chronic kidney disease, with Stage 5 being the most advanced stage. | This measure includes patient only. | Count of Participants | Participants |
|
| TTM Stage | The TTM stages of change in lifestyle modification were assessed using five statements based on the Transtheoretical Model (TTM). Patients and their significant others self-assessed their motivation for lifestyle modification, identifying as being in the "precontemplation," "contemplation," "preparation," "action," or "maintenance" stage. | This measure was reported jointly by the patient and the significant other within each dyad. | Number | dyad |
|
| Health Promoting Lifestyle | Patients' lifestyles were 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 score ranges from 52 to 208, with higher scores indicating better health-promoting behavior. | This measure includes patients only. | Mean | Standard Deviation | units on a scale |
|
| Adherence to Healthy Behaviors | Patients' adherence to healthy behaviors over the past month 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. | This measure includes patient only. | Mean | Standard Deviation | units on a scale |
|
| Helping Relationships from Significant Others | Patients' perceived support from their significant others over the past month 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, with higher scores indicating better support. | This measure includes patient only. | Mean | Standard Deviation | units on a scale |
|
| Dyadic Adjustment | The quality of the relationship between the patient and their significant other 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, with total scores ranging from 0 to 36. Higher scores indicate better relationship quality. | 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. | Mean | Standard Deviation | units on a scale |
|
| Quality of Life | The Taiwanese version of the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF) was used to assess the quality of life of patients and their significant others over the past two weeks. The first item assessing general quality of life, rated on a 5-point Likert scale (score range: 1 to 5), was reported for this measure. Higher scores indicate better quality of life. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Control Group | The control group receives routine education and care. |
|
|
| 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]). | This measure was conducted only on the patient participants. | Posted | Count of Participants | Participants | Before initial intervention and 3 months after initial intervention |
|
|
|
| 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]). | This measure was reported jointly by the patient and the significant other within each dyad. | Posted | Number | dyad | Before initial intervention and 3 months after initial intervention |
|
|
|
| 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. | This questionnaire was only administrated to the patient participants. | Posted | Mean | 95% Confidence Interval | score on a scale | Before initial intervention and 3 months after initial intervention |
|
|
|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Before initial intervention and 3 months after initial intervention |
|
|
|
| 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. | This questionnaire was only administrated to the patient participants. | Posted | Mean | 95% Confidence Interval | score on a scale | Before initial intervention and 3 months after initial intervention |
|
|
|
| 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. | This questionnaire was only administrated to the patient participants. | Posted | Mean | 95% Confidence Interval | score on a scale | Before initial intervention and 3 months after initial intervention |
|
|
|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Before initial intervention and 3 months after initial intervention |
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | Control Group | The control group receives routine education and care. | 0 | 60 | 0 | 60 | 0 | 60 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Male |
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| Stage 3a |
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| Stage 3b |
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| Stage 4 |
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| Stage 5 |
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| Progress |
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| Advance |
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