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Understandable drug information


- candidate number22987
- NTR NumberNTR5699
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-okt-2015
- Secondary IDsP15.209 
- Public TitleUnderstandable drug information
- Scientific TitleThe effect of a pictogram-guided antihypertensive drug leaflet on patientsí recall and understanding of information, self-efficacy, adherence and blood pressure control.
- ACRONYM
- hypothesisWe expect that, 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 patientsí 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.
- Healt Condition(s) or Problem(s) studiedHypertension
- Inclusion criteriaAdult patients who get prescribed antihypertensive medication for the first time, or for the first time after at least a year of not having received this medication.
- Exclusion criteriaA potential subject who meets any of the following criteria will be excluded from participation in this study:
- unable to verbally communicate in Dutch
- blind
- under 18 years of age
- incapacitated
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 28-okt-2015
- planned closingdate1-jan-2017
- Target number of participants180
- InterventionsThe control group will receive a secondary patient information leaflet that is text-only; the intervention group will receive the same information with pictograms added.
- Primary outcomeThe main study parameter is change in blood pressure control between baseline and the first standard control measurement compared between the control and intervention group.
- Secondary outcomeParticipantsí use of the leaflet and their perceived comprehensibility, utility and design quality of the leaflet, as well as their recall and understanding of information, self-efficacy, intention to adhere and self-reported adherence will be assessed in the interview and represented by scores that will be compared between the control and intervention group.
- TimepointsBlood pressure control means that the patient has achieved the target blood pressure that was set out by their treating physician. Values at baseline (last measurement by HCP before first prescription of antihypertensive drugs) will be compared to blood pressure measurements of the first routine check-up (usually three weeks after start of medication). The secondary outcomes will be measured during two interviews - one at t=2-3 weeks and one at t=4-5 weeks after the patients have received the leaflet in the pharmacy.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES M.M. van Beusekom
- CONTACT for SCIENTIFIC QUERIES M.M. van Beusekom
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD19-okt-2015 - 16-apr-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl