Chronic Kidney Diseases
Conditions
Keywords
digital health, dyadic empowerment, healthy lifestyle
Brief summary
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: * Does DDEP help protect kidney function? * Does DDEP support healthier daily habits? Researchers will compare two groups: * One group will receive the DDEP and get usual medical care. * The other group will get usual medical care only. Participants will: * Receive usual care with or without DDEP for six months. * Visit the clinic at the start and end of the study for health checks and tests. * Practice healthy habits at home with or without help from DDEP. 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.
Detailed description
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.
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.
BEHAVIORALUsual Care
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.
Sponsors
National Cheng Kung University
National Health Research Institutes, Taiwan
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; 4. Neither the patient nor the significant other uses a smartphone or the LINE messaging app.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in eGFR at 6 Months (Patient-specific) | Before initial intervention and 6 months after initial intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in CKD Stage at 6 Months (Patient-specific) | Before initial intervention and 6 months after initial intervention | 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 \[at follow-up\]). |
| Change From Baseline in TTM Stage at 6 Months (Patient-specific) | Before initial intervention and 6 months after initial intervention | 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 \[at follow-up\]). |
| Change From Baseline in Health Promoting Lifestyle at 6 Months (Patient-specific) | Before initial intervention and 6 months after initial intervention | 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. |
| Change From Baseline in Dyadic Adjustment at 6 Months | Before initial intervention and 6 months after initial intervention | 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. |
Countries
Taiwan
Contacts
PRINCIPAL_INVESTIGATORMiaofen Yen, PhD
National Cheng Kung University
Participant flow
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous Patient | 68.02 years STANDARD_DEVIATION 13.92 |
| Age, Continuous Significant other | 58.49 years STANDARD_DEVIATION 12.62 |
| CKD Stage Stage 1 | 10 Participants |
| CKD Stage Stage 2 | 8 Participants |
| CKD Stage Stage 3a | 14 Participants |
| CKD Stage Stage 3b | 10 Participants |
| CKD Stage Stage 4 | 8 Participants |
| CKD Stage Stage 5 | 7 Participants |
| Dyadic Adjustment Patient | 25.71 units on a scale STANDARD_DEVIATION 7.3 |
| Dyadic Adjustment Significant other | 23.83 units on a scale STANDARD_DEVIATION 7.46 |
| eGFR | 48.82 mL/min/1.73m^2 STANDARD_DEVIATION 25.35 |
| Health Promoting Lifestyle | 85.90 units on a scale STANDARD_DEVIATION 16 |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Patient Female | 51 Participants |
| Sex: Female, Male Patient Male | 27 Participants |
| Sex: Female, Male Significant other Female | 31 Participants |
| Sex: Female, Male Significant other Male | 16 Participants |
| TTM Stage Action | 7 Participants |
| TTM Stage Contemplation | 2 Participants |
| TTM Stage Maintenance | 35 Participants |
| TTM Stage Precontemplation | 2 Participants |
| TTM Stage Preparation | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 104 | 0 / 104 |
| other Total, other adverse events | 5 / 104 | 1 / 104 |
| serious Total, serious adverse events | 0 / 104 | 0 / 104 |
Outcome results
None listed