Our objective is to determine if, compared to a standard text-only, a leaflet with pictograms leads to better perceived comprehensibility, utility and design quality of the leaflet by consumers. This could lead to better recall and understanding of…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
communicatie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is change in blood pressure control between baseline
and the first standard control measurement (usually three weeks after start of
medication) compared between the control and intervention group.
Secondary outcome
Other measures are differences in overall understanding of the information
provided in the leaflet, satisfaction with the information, self-efficacy, and
(intention to) adherence between the control and intervention group.
Background summary
Previous studies have shown that use of pictograms can improve the quality of
written drug information, in particular for people who have difficulty reading
and understanding health information. We have developed targeted pictograms,
based on visual needs and preferences of people with low literacy levels. The
aim of this study is to evaluate the effect of these pictograms in the context
of existing patient leaflets for antihypertensive drugs.
Study objective
Our objective is to determine if, compared to a standard text-only, a leaflet
with pictograms leads to better perceived comprehensibility, utility and design
quality of the leaflet by consumers. This could lead to better recall and
understanding of the drug information, increasing patients* self-efficacy, and
in turn intention to adhere and actual adherence, which could lead to better
blood pressure control. Additionally, we aim to gain insight into the question
as to whether such intervention is especially beneficial for low-literate
people, who are not sufficiently helped with a text-only leaflet format.
Study design
Cluster randomised design
Intervention
The control group will receive a standard care, text-only drug information
leaflet with their medication. The test group will receive the leaflet enriched
with pictograms.
Study burden and risks
A participating patient will experience standard care, with the additional
burden of signing informed consent and answering questions in an interview. The
interview will be planned at a time that is convenient for the patient to limit
additional burden. The drug leaflets used in the study are currently in use at
the LUMC outpatient pharmacy. Participants* (health) literacy will be assessed,
so that there is a risk of labelling the participant as literate or
low-literate. To minimize this effect it will be explained that the literacy
test provides insight into the gap between the level at which health
information is offered and the level that matches the information needs of its
target group. Direct benefits for participants include receiving potentially
more user-friendly information on their medication, and contributing to the
general advancement of patient drug information and safe medication use.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria: to get an antihypertensive prescribed for the first time and to not have used an antihypertensive the year before.
Exclusion criteria
- unable to verbally communicate in Dutch
- blind
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL53876.058.15 |