Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2026-03-01 @ 6:11 AM
Study NCT ID:
NCT03428035
Status:
UNKNOWN
Last Update Posted:
2018-10-09
First Post:
2018-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of a Neutral Formulated and Designed Package Insert on Nocebo-effect.
Sponsor:
University of Witten/Herdecke
Organization:
Study Overview
Official Title:
Neutral Formulated and Designed Package Insert or Only Verbal Information Compared to Package Insert According EU-directive: a Pilot Randomised Controlled Trial to Analyse the Influence on the Nocebo Effect and Non-adherence
Status:
UNKNOWN
Status Verified Date:
2018-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NEUPANO
Brief Summary:
Background The nocebo effect describes the association between the expectation of negative effects, (e.g. side effects) and the actual occurrence of negative effects. Studies have shown that the nocebo effect can be influenced by (risk) communication. Till today there is no study that compares different types of information on adverse events regarding the strength of the nocebo effect.
Aim The aim of this pilot randomized controlled trial is to analyse the influence of different communication types on the frequency and intensity of adverse events and adherence. To increase the relevance and applicability of the results the study intervention builds up on package inserts because these are the most widespread form of information on side effects.
Methods Patients It is planned to include 60 patients in the study.
Intervention
* Modified package insert: simplified and focused on neutral risk perception. The representations and formulations are based on the findings from research on evidence-based patient information and risk communication. The package insert contains the same information as the statutory package insert to ensure that it complies with the legal requirements.
* Verbal information about side effects: The patient is informed verbally about side effects and does not receive any package insert.
Control Package insert according to EU (European Union) Directive 2001/83 / EC (European Commission) (usual package insert).
Outcomes
* Number of patient reported adverse events (primary outcome).
* Adherence (correct initiation of therapy, correct intake amount, premature discontinuation of therapy).
* Resource use (e.g. provider contacts).
Type of study Monocentric, outcome assessor, three-arm, randomised controlled pilot trial.
Aim The aim of this pilot randomized controlled trial is to analyse the influence of different communication types on the frequency and intensity of adverse events and adherence. To increase the relevance and applicability of the results the study intervention builds up on package inserts because these are the most widespread form of information on side effects.
Methods Patients It is planned to include 60 patients in the study.
Intervention
* Modified package insert: simplified and focused on neutral risk perception. The representations and formulations are based on the findings from research on evidence-based patient information and risk communication. The package insert contains the same information as the statutory package insert to ensure that it complies with the legal requirements.
* Verbal information about side effects: The patient is informed verbally about side effects and does not receive any package insert.
Control Package insert according to EU (European Union) Directive 2001/83 / EC (European Commission) (usual package insert).
Outcomes
* Number of patient reported adverse events (primary outcome).
* Adherence (correct initiation of therapy, correct intake amount, premature discontinuation of therapy).
* Resource use (e.g. provider contacts).
Type of study Monocentric, outcome assessor, three-arm, randomised controlled pilot trial.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: