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| Name | Class |
|---|---|
| National Health Research Institutes, Taiwan | OTHER |
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The goal of this clinical trial is to find out if the Digital Dyadic Empowerment Program (DDEP) can help people with chronic kidney disease (CKD) and their care partners make healthy lifestyle changes. The main questions this study will answer are:
Researchers will compare two groups:
Participants will:
This study aims to show if adding DDEP to regular care can make it easier for people with CKD and their care partners to live healthier lives.
This randomized controlled trial (RCT) aims to evaluate the long-term effects of the Digital Dyadic Empowerment Program (DDEP) in comparison to routine care for people with chronic kidney disease (CKD) and their significant others. The study will assess whether the DDEP can improve health outcomes such as kidney function, health-promoting lifestyle behaviors, and the quality of relationships between significant others over a six-month period. The trial will follow the Consolidated Standards of Reporting Trials (CONSORT) 2010 and CONSORT-EHEALTH guidelines to ensure rigorous reporting and transparency.
Baseline assessments will occur in a private clinic room and will include demographic information, disease-related characteristics, and self-reported measures. Participants in both groups will also complete the Trans-Theoretical Model (TTM) staging inventory to evaluate their readiness for lifestyle changes. Dyads assigned to the intervention group will receive DDEP setup instructions and training on platform use during the baseline visit. Throughout the study, dyads will be encouraged to utilize the platform for self-management tasks at home, including diet tracking, exercise planning, and monitoring blood pressure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital Dyadic Empowerment + Usual Care | Experimental | The intervention group (Digital Dyadic Empowerment + Usual Care) will receive usual care and utilize LINE, a prominent instant messaging App in Taiwan, to assist in lifestyle modification at home along with support from the significant other. |
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| Usual Care | Active Comparator | The control group will receive usual care only. |
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| 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 6 Months (Patient-specific) | 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. | Before initial intervention and 6 months after initial intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in CKD Stage at 6 Months (Patient-specific) | 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]). |
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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 |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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:
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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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For each group, there are 52 dyads (i.e., 52 patients and their 52 significant others, totalling 104 participants) for baseline assessment. The overall number of baseline participants is therefore 208 (104*2).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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:
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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 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. |
| 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 6 Months (Patient-specific) | 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. | 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. | Posted | Mean | Standard Error | mL/min/1.73m^2 | Before initial intervention and 6 months after initial intervention |
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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.
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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 | 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:
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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Self-reported medical visit (unrelated) | General disorders | Non-systematic Assessment | Participant-initiated reports of physical discomfort requiring medical evaluation/treatment during follow-up; events were judged not related to the digital intervention. Examples: hyponatremia, renal cyst, fracture, syncope, dialysis initiation. |
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chun-Yi Ho, Research Assistant | Department of Nursing, College of Medicine, 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 13, 2024 | Jan 8, 2026 | 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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| Usual Care | Behavioral | All patients in this study received regular nephrology care at National Cheng Kung University Hospital. Nephrologists conducted routine examinations and provided diagnoses based on test results. The patient's condition (e.g., changes in kidney function), treatment plan, prognosis, and risks were explained to both the patient and family members. The treatment plan included medication, monitoring blood pressure, dietary and exercise at home, and consultations with the Health Education Center for kidney care or nutrition advice. |
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| Before initial intervention and 6 months after initial intervention |
| Change From Baseline in TTM Stage at 6 Months (Patient-specific) | 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]). | Before initial intervention and 6 months after initial intervention |
| Change From Baseline in Health Promoting Lifestyle at 6 Months (Patient-specific) | 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. | Before initial intervention and 6 months after initial intervention |
| Change From Baseline in Dyadic Adjustment at 6 Months | 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. | Before initial intervention and 6 months after initial intervention |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | 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. | Count of Participants | Participants |
|
| eGFR | Estimated Glomerular Filtration Rate (eGFR) by the IDMS-MDRD Equation | 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. | Mean | Standard Deviation | mL/min/1.73m^2 |
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| 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. All 104 patients had baseline CKD Stage data available. | 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 self-assessed their motivation for lifestyle modification, identifying as being in the "precontemplation," "contemplation," "preparation," "action," or "maintenance" stage. | This measure includes patient only. All 104 patients had baseline TTM Stage data available. | Count of Participants | Participants |
|
| Health Promoting Lifestyle | Patients' lifestyles were assessed using the Health Promoting Lifestyle Profile-II Chinese Revised (HPLP-IICR), a validated scale with 30 items rated on a 4-point Likert scale. The total score ranges from 30 to 120, with higher scores indicating better health-promoting lifestyle. | This measure includes patient only. All 104 patients had baseline HPLP-IICR data available. | 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. | All 208 participants completed the baseline measure of DAS-7. We report the score distribution for patient and significant other separately. | Mean | Standard Deviation | units on a scale |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 | 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. |
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| Secondary | Change From Baseline in CKD Stage at 6 Months (Patient-specific) | 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]). | 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. | Posted | Count of Participants | Participants | Before initial intervention and 6 months after initial intervention |
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| Secondary | Change From Baseline in TTM Stage at 6 Months (Patient-specific) | 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]). | 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. | Posted | Count of Participants | Participants | Before initial intervention and 6 months after initial intervention |
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| Secondary | Change From Baseline in Health Promoting Lifestyle at 6 Months (Patient-specific) | 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. | 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. | Posted | Mean | Standard Error | units on a scale | Before initial intervention and 6 months after initial intervention |
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| Secondary | Change From Baseline in Dyadic Adjustment at 6 Months | 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. | 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. | Posted | Mean | Standard Error | units on a scale | Before initial intervention and 6 months after initial intervention |
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|
| 0 |
| 104 |
| 0 |
| 104 |
| 5 |
| 104 |
| EG001 | 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. | 0 | 104 | 0 | 104 | 1 | 104 |
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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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| Preparation |
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| Action |
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| Maintenance |
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| Progress |
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| Advance |
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