Dyadic mobile intervention empowering lifestyle modification in chronic kidney disease management: A feasibility randomized controlled trial.

BACKGROUND

Sustaining lifestyle modification is essential for managing chronic kidney disease. Dyadic mobile interventions engaging patients and their significant others (a spouse or adult child) may offer potential support, yet their feasibility in clinical nursing practice requires evaluation.

OBJECTIVE

To evaluate the feasibility, acceptability, and safety of a clinic-integrated Digital Dyadic Empowerment Program to inform a full-scale trial.

DESIGN

A two-arm, parallel-group randomized controlled trial.

SETTINGS: Nephrology outpatient clinics at a medical center in Taiwan.

PARTICIPANTS

Sixty patient-caregiver dyads (120 individuals).

METHODS

Dyads were randomized 1:1 to receive a staff-assisted mobile intervention providing lifestyle support plus usual care (intervention group), or usual care alone (control group) for 3 months. Feasibility criteria included: recruitment of ≥ 30 dyads monthly, study completion rate ≥ 80%, average 90-day platform usage rate (use days/90) ≥ 50%, and adverse event rate < 5%.

RESULTS

The recruitment target was met in 46 days (60 dyads from 2214 screened), the efficiency was ∼39 dyads per month. The retention rate was high at 91.7% (55[26+29]/60, 95% CI [81.9, 96.4]), with attrition primarily linked to older age and caregiver burden. Platform uptake was 100%, but the 90-day platform usage rates averaged 48.93% (1145/2340[26 × 90], 95% CI [46.91, 50.96]) among completers. A bimodal pattern emerged: 14 high-usage dyads averaged 87.06% (1097/1260[14 × 90], 95% CI [85.10, 88.80]) while 12 low-usage dyads averaged 4.44% (48/1080[12 × 90], 95% CI [3.37, 5.84]). No adverse events occurred (0%, 0/60, 95% CI [0.0, 6.0]), but 1 intervention dyad withdrew due to psychological burden of daily self-monitoring.

CONCLUSIONS

Digital Dyadic Empowerment Program is safe and feasible to integrate into routine care, demonstrating efficient recruitment and high retention. However, variable engagement and potential burden highlight the need for tailored nursing support and refined onboarding procedures. A full-scale trial will proceed using our proposed protocol adaptations.

REGISTRATION: ClinicalTrials.gov, NCT06226649. Registered January 18, 2024; first recruitment January 29, 2024.