Dataset Information
Lessons learned from two clinical trials on nutritional supplements to reduce aggressive behaviour.
Ontology highlight
ABSTRACT: Background
Setting up and conducting a randomised controlled trial (RCT) has many challenges-particularly trials that include vulnerable individuals with behavioural problems or who reside in facilities that focus on care as opposed to research. These populations are underrepresented in RCTs.Approach
In our paper, we describe the challenges and practical lessons learned from two RCTs in two care settings involving long-stay psychiatric inpatients and people with intellectual disabilities. We describe five main difficulties and how these were overcome: (1) multisite setting, (2) inclusion of vulnerable participants, (3) nutritional supplements and placebos, (4) assessment of behavioural outcomes, and (5) collecting bio samples.Conclusions
By sharing these practical experiences, we hope to inform other researchers how to optimally design their trials, while avoiding and minimising the difficulties that we encountered, and to facilitate the implementation of a trial. Both trials were registered in the Clinical Trials Register (RCT A: NCT02498106; RCT B: NCT03212092).
SUBMITTER: de Bles NJ
PROVIDER: S-EPMC9543803 | biostudies-literature | 2022 Aug
REPOSITORIES: biostudies-literature
Publications
Lessons learned from two clinical trials on nutritional supplements to reduce aggressive behaviour.
Journal of evaluation in clinical practice 20220117 4
<h4>Background</h4>Setting up and conducting a randomised controlled trial (RCT) has many challenges-particularly trials that include vulnerable individuals with behavioural problems or who reside in facilities that focus on care as opposed to research. These populations are underrepresented in RCTs.<h4>Approach</h4>In our paper, we describe the challenges and practical lessons learned from two RCTs in two care settings involving long-stay psychiatric inpatients and people with intellectual disa ...[more]