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N/A N=60 Randomized Triple-blind Supportive Care

DDEP for Lifestyle Modification in Chronic Kidney Disease

Chronic Kidney Diseases

Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Change From Baseline in eGFR at 3 Months (Patient-specific) — -1.71; -4.12 ml/min/1.73m^2

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Digital Dyadic Empowerment (Behavioral)
Age
Adult, Older Adult · 20+ yrs
Sex
All
Sponsor
National Cheng Kung University
Primary completion
Nov 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline in eGFR at 3 Months (Patient-specific)
-1.71; -4.12
PRIMARY
Change From Baseline in CKD Stage at 3 Months (Patient-specific)
2; 4; 18; 20; 6; 5
PRIMARY
Change From Baseline in TTM Stage at 3 Months
4; 5; 14; 19; 8; 5
PRIMARY
Change From Baseline in Health Promoting Lifestyle at 3 Months (Patient-specific)
5.96; -8.17
PRIMARY
Change From Baseline in Quality of Life at 3 Months
-0.02; -0.16
SECONDARY
Change From Baseline in Adherence to Health Behaviors at 3 Months (Patient-specific)
1.81; 0.10
SECONDARY
Change From Baseline in Helping Relationships From Significant Others at 3 Months (Patient-specific)
4.42; -8.86
SECONDARY
Change From Baseline in Dyadic Adjustment at 3 Months
2.49; -1.47

Summary

This is a randomized controlled feasibility trial conducted on patients with Chronic Kidney Disease (CKD) and their significant other

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06226649). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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