Participants in clinical research are often very interested in opportunities for education about their health. Depending on the type of research, health education materials may either be used as part of a study intervention (if the impact of the materials is measured or different materials are used between groups) or may be provided as part of an engagement and retention strategy. Another option is in-person or online events where researchers can talk about their broader research program (rather than project specifics). These can provide a greater understanding of the condition and provide a valuable opportunity for participants to ask questions of researchers directly.
If the health education is not part of the study intervention, they should be provided on an opt-in basis to avoid overwhelming participants who aren’t interested.
Considerations
- Health education materials may either be used as part of a study intervention (if the impact of the materials is measured or different between groups), or may be provided as part of an engagement and retention strategy.
- Materials that are part of the study intervention would need to be reviewed by the ethical review body, but researchers should discuss with their ethical review bodies if a communication plan outlining how participant contact information will be managed would be sufficient.
- Materials that are not part of the intervention should be provided with an opt-in approach, as not all participants will want additional information.
Participant experience
- Health education could be achieved through offering education events (such as in-person seminars or expos relevant to the research topic), using educational materials created by relevant groups (e.g. condition newsletters), or creating resources specific to your population.
- If using existing resources, it can be useful to provide site staff with a brief about any content particularly relevant to the study so that they can engage with the participant about that section.
- Ask your consumer reference group about the most relevant materials or experiences for the target population.
- If your trial is blinded, be careful to set boundaries for situations where participants are talking to each other to discourage speculation on which arm of the trial they are in.
- I was asked if I wanted to be connected to different resources relevant to my condition, which was really useful for me.
- I had no idea about stroke whatsoever when it happened to me, and that meant that I was eating up information wherever it came from.
- I think it's positive for a lot of people have more personal knowledge about their condition.
- You want to make the information supportive but not smothering. It's about keeping it simple.
- If you don't direct someone to the right information, then you risk increasing their anxiety. Not everybody knows about their disease, even though they've got the disease. So that's why I think it’s more useful to have a trial specific newsletter.
Suggestions
- Health education could be achieved through offering education events (such as in-person seminars or expos relevant to the research topic), using educational materials created by relevant groups (e.g. condition newsletters), or creating resources specific to your population.
- If using existing resources, it can be useful to provide site staff with a brief about any content particularly relevant to the study so that they can engage with the participant about that section.
- Ask your consumer reference group about the most relevant materials or experiences for the target population.
- If your trial is blinded, be careful to set boundaries for situations where participants are talking to each other to discourage speculation on which arm of the trial they are in.
