Clinical trial · Interventional
Effect of Communicating Structured Benefit and Harm Information in European Patient Leaflets on Individuals' Expectations About Medicines
Effect of Communicating Structured Benefit and Harm Information in European Patient Leaflets on Individuals' Expectations About New Medicines: a Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This online randomized controlled trial will evaluate whether adding a key information section to patient information leaflets leads to more accurate expectations and improves participants' understanding. We will test the impact of including quantitative information on drug benefits in addition to qualitative statements, versus including qualitative statements only. Participants will be randomly assigned to one of three groups: (1) a standard patient leaflet that contains no information on drug benefits, (2) a leaflet featuring a key information section that includes qualitative statements about drug benefits, or (3) a leaflet featuring a key information section that includes quantitative information about drug benefits in addition to qualitative statements.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control (standard patient leaflet) | Other | — | UNRESOLVED |
| Patient leaflet with a key information section providing both qualitative and quantitative information on drug benefits and harms. | Other | — | UNRESOLVED |
| Patient leaflet with the EMA's proposed key information section including qualitative statements. | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- PLACEBO_COMPARATOR
- label
- Control (standard patient leaflet)
- interventionNames
- Other: Control (standard patient leaflet)
- type
- EXPERIMENTAL
- label
- Patient leaflet with the EMA's proposed key information section including qualitative statements
- interventionNames
- Other: Patient leaflet with the EMA's proposed key information section including qualitative statements.
- type
- EXPERIMENTAL
- label
- Patient leaflet with a key information section providing qualitative and quantitative information
- interventionNames
- Other: Patient leaflet with a key information section providing both qualitative and quantitative information on drug benefits and harms.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adults 18 years of age and older, * Adults fluent in English, * Adults residing in the United Kingdom (i.e., nationally representative sample of UK adults). Exclusion critera: \- Participants who do not meet all 3 inclusion criteria.
References
Publications (0)
Data not yet available