DDEP for Lifestyle Modification in Chronic Kidney Disease
- Conditions
- Chronic Kidney Diseases
- Interventions
- Behavioral: Digital Dyadic Empowerment
- Registration Number
- NCT06226649
- Lead Sponsor
- National Cheng Kung University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- The patient has a diagnosis of Chronic Kidney Disease for at least six months;
- The patient can identify a helpful significant other and both parties are willing to participate;
- The patient can communicate in Mandarin or Taiwanese.
- The significant other is a healthcare provider;
- The patient or the significant other has a mental illness diagnosis;
- The patient is currently receiving renal replacement therapies.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Digital Dyadic Empowerment 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.
- Primary Outcome Measures
Name Time Method 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.
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 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.
- Secondary Outcome Measures
Name Time Method 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.
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.
Trial Locations
- Locations (1)
National Cheng Kung University
🇨🇳Tainan City, Taiwan