The iADJUST Study Protocol: A Randomised Waitlist-Controlled Feasibility Trial of iADJUST, a Digital Psychological Intervention for People Living with Chronic Kidney Disease
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Background
Psychological distress is common among people living with chronic kidney disease (CKD), yet access to structured psychological support within routine kidney care remains limited and varied. iADJUST is a primarily self-guided digital psychological intervention designed to support adjustment and emotional well-being in people living with CKD. Delivered over 12 weeks, iADJUST is hosted on the Kidney BEAM platform and supported by brief therapist contact to facilitate engagement. Before a definitive evaluation can be undertaken, it is necessary to establish the feasibility and acceptability of intervention delivery and study procedures.
Aim
To assess the feasibility and acceptability of delivering iADJUST to people living with CKD.
Methods
This study is a parallel-group, randomised, waitlist-controlled feasibility trial. Approximately 40-50 adults with CKD who are not receiving renal replacement therapy and have not received a kidney transplant will be randomised 1:1 to receive either iADJUST plus usual care or usual care alone. iADJUST is a six-session digital psychological intervention delivered over 12 weeks and supported by brief therapist contact. Feasibility outcomes include recruitment, retention, intervention uptake, engagement, completion of outcome measures, and acceptability of study procedures. Exploratory outcome measures include psychological distress, fatigue, functional impairment and quality of life collected to estimate variability, assess data completeness, and inform outcome selection for a future definitive trial. Following the primary endpoint assessment at 12 weeks, participants in both groups will receive access to the exercise-based Kidney BEAM programme. Kidney BEAM engagement and completion will be assessed at 24 weeks. The study is not powered to detect statistically significant between-group differences in clinical outcomes.
Conclusion
This study will provide evidence regarding the feasibility and acceptability of delivering iADJUST within UK kidney care pathways and inform the design of a future definitive trial.
Trial Registration
ISRCTN91507822
