Randomised controlled trial of a video intervention and behaviour contract to improve medication adherence after renal transplantation: the VECTOR study protocol.
Mansell, H., Rosaasen, N. et al. (2019).BMJ Open 9(3): e025495.
Aims
To determine the effectiveness of an electronically delivered video series and adherence behaviour contract on improving medication adherence to immunosuppressant medications.
Interventions
Participants will be randomised to either the intervention group where they will receive standard education along with the home-based video education plus a behaviour contract or usual care alone.
Participants
Patients who have received a de novo kidney transplant.
Outcomes
Primary outcome will be measured as medication adherence. Secondary outcomes include the difference in change in knowledge score between the intervention and control groups, and differences between the intervention and control in the following measures: self-efficacy, beliefs about medications, quality of life, satisfaction with education, adherence to appointments and days in hospital.
Follow-up
12 months.
CET Conclusions
This is a trial protocol paper of the VECTOR trial, which aims to test the effectiveness of a video intervention plus adherence contract versus usual care to improve medication adherence among de novo kidney transplant patients. The multicentre trial will be conducted in four transplant centres across North America. The video intervention describes the kidney transplant process and was developed for and with patients, and patient stakeholders. The videos will supplement routine post-transplant education care and the adherence contract will be completed around 1 month after transplantation. Randomisation will be done centrally and study sites will receive sequentially numbered survey participant links ensuring concealed allocation. The study team will be blinded and participants will be asked not to share the details of the intervention with the study team. The primary outcome adherence at 12 months will be assessed by using an electronic self-report assessment tool. The power calculation based on the primary outcome shows that the 268 patients are needed for 80% power, which accounts for a drop-out rate of 25%.
Trial registration
ClinicalTrials.gov - NCT03540121