A phase II pilot randomized controlled trial of an integrated stepped collaborative care intervention for patients awaiting kidney transplantation (CARES-transplant).
Kallem, C. J., et al.J Behav Med. 2025 Oct;48(5):731-744.
Aims
This study aimed to compare the feasibility and efficacy of an integrated stepped collaborative care intervention (CARES‑transplant) with that of standard of care for patients in the waiting list for kidney transplantation.
Interventions
Participants were randomised either CARES‑transplant or standard of care.
Participants
19 adult pateints on the waitlist for deceased donor kidney transplant.
Outcomes
The main outcomes of interest were the assessment of pain intensity and interference, fatigue and its effects on daily functioning, presence and frequency of depressive symptoms, health-related quality of life (HRQOL), perceived stress and sleep quality.
Follow-up
3 months
CET Conclusions
This small phase II pilot study explored the impact of a stepped collaborative care intervention (CARES-transplant) on patient and caregiver reported outcomes for patients on the kidney transplant waiting list. The intervention is based on cognitive behavioural therapy (CBT), targeting pain, depressive symptoms and fatigue. Duration of treatment and use of medication was adapted to patient’s symptoms. The authors found trends towards improved pain, fatigue and depressive symptoms, as well as numerically lower unplanned care episodes with the intervention. Firm conclusions are difficult due to the small sample size, along with 20% loss to follow-up. As with most complex interventions of this type, adaptation to other centres and settings may be challenging, especially where there are younger patients and a high proportion of non-English speaking patients. Patients were only followed for 3 months, so the durability of the intervention has yet to be assessed. Overall, the intervention does show promise worthy of further investigation to see if it can scale to a wider patient population.
Data analysis
Strict intention-to-treat analysis
Trial registration
ClinicalTrials.gov - NCT02938351