Transplant Trial Watch

Web-Based Tailored Intervention to Support Optimal Medication Adherence Among Kidney Transplant Recipients: Pilot Parallel-Group Randomized Controlled Trial.

Cote, J., Fortin, M. C. et al. (2018).

JMIR Formative Research 2(2): e14.


Aims
This study aimed to evaluate the Transplant-TAVIE intervention’s acceptability, feasibility, and preliminary efficacy.

Interventions
Kidney transplant patients on immunosuppressive medication were randomly assigned either to an experimental group (Transplant-TAVIE) (n=35) or to a control group (existing medication websites) (n=35).

Participants
70 kidney transplant patients on immunosuppresive medication.

Outcomes
The primary outcome of this trial was medication adherence. Secondary outcomes included self-efficacy, skills, medication, side-effects and self-perceived general state of health.

Follow-up
6 months

CET Conclusions
This pilot randomised controlled trial aimed to assess the feasibility, acceptability and preliminary efficacy of Transplant-TAVIE, a web-based tailored nursing intervention that was developed to support medical adherence among kidney transplant recipients. Transplant-TAVIE consisted of three interactive, web-based sessions hosted by a virtual nurse that aimed to gradually increase knowledge and abilities. The control group was invited to visit three conventional transplantation-related websites offering information. No sample size calculation was performed for this pilot study. The randomisation list was computer-generated and allocation was concealed by using numbered, opaque, sealed envelopes. Data entry was blinded. Analysis was based on intention to treat but missing data were not imputed. Seventy patients were randomised of which only 39 (23 (Transplant-TAVIE) versus 16 (control)) completed the six-month follow up questionnaire. The main reason for withdrawal was described as ‘Did not respond’ (n=24). Transplant-TAVIE was evaluated among 18 participants and was generally found to be acceptable and all participants would recommend the intervention to other transplant recipients. These pilot data found no differences between groups regarding the efficacy at any time point.

Jadad score
3

Data analysis
Modified intention-to-treat analysis

Allocation concealment
Yes

Trial registration
None

Funding source
Non-industry funded