Clinical trial NCT06226649: DDEP for Lifestyle Modification in Chronic Kidney Disease
Official title: A Randomized Controlled Feasibility Trial Evaluating the Implementation of Digital Dyadic Empowerment Program (DDEP) on Lifestyle Modification for Chronic Kidney Disease Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Diseases
Keywords: feasibility studies
digital health
healthy lifestyle
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
Collaborators: name: National Health Research Institutes, Taiwan
First posted: 2024-01-26
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in eGFR at 3 Months (Patient-specific)
timeFrame: Before initial intervention and 3 months after initial intervention
measure: Change From Baseline in CKD Stage at 3 Months (Patient-specific)
timeFrame: Before initial intervention and 3 months after initial intervention
measure: Change From Baseline in TTM Stage at 3 Months
timeFrame: Before initial intervention and 3 months after initial intervention
measure: Change From Baseline in Health Promoting Lifestyle at 3 Months (Patient-specific)
timeFrame: Before initial intervention and 3 months after initial intervention
measure: Change From Baseline in Quality of Life at 3 Months
timeFrame: Before initial intervention and 3 months after initial intervention
Secondary outcomes:
measure: Change From Baseline in Adherence to Health Behaviors at 3 Months (Patient-specific)
timeFrame: Before initial intervention and 3 months after initial intervention
measure: Change From Baseline in Helping Relationships From Significant Others at 3 Months (Patient-specific)
timeFrame: Before initial intervention and 3 months after initial intervention
measure: Change From Baseline in Dyadic Adjustment at 3 Months
timeFrame: Before initial intervention and 3 months after initial intervention
Other outcomes:
Locations:
city: Tainan City
country: Taiwan
facility: National Cheng Kung University
Study officials:
affiliation: National Cheng Kung University
name: Miaofen Yen, PhD
role: PRINCIPAL_INVESTIGATOR
References: