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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05505058
Other study ID # 2019-01797
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2019
Est. completion date June 30, 2022

Study information

Verified date August 2022
Source University Hospital, Geneva
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Ethical research on detained persons remains limited, including research on informed consent. This study aimed to fill in this research gap and compared audio-visual and paper-based materials for a one-time general informed consent for research in prison, using a randomized design. The primary outcome was whether participants sign the inform consent. Secondary outcomes included understanding, evaluation, and time to read/watch the informed consent.


Description:

Detained persons constitute a very vulnerable and perhaps reluctant to share their medical data. In particular, it is crucial to ensure that these persons, deprived of their liberty, understand that their consent is voluntary and that a refusal will not have any consequence on their treatment or care. In other words, it is necessary to ensure that consent is informed. In a historical context of non-ethical research using detained persons, this is a crucial issue. However, while detained persons are now protected from various forms of abuse, this may have had the consequence of reducing research involving them, to the detriment of understanding their characteristics and vulnerabilities. A general consent for research will encourage research on prison populations by facilitating access to their medical data in order to study and reduce health disparities, for this population with multiple somatic and psychiatric comorbidities. Our main questions are: Q1. What is the acceptability rate of general consent for research in detained persons? Q2. What are the characteristics (socio-demographic and medical) of detained person who refuse to give their consent? Q3. Which material (paper-based or video) is more effective? To answer these research question, we will use an exploratory randomized cross-sectional trial, conducted in an adult pre-trial prison and a juvenile detention center. Participants will be randomly assigned to read or watch information about informed consent, stratified on the prison. In both prisons, the study will take place in the prison medical unit. This project is aimed to improve general consent, which contributes to reducing inequalities in documentation on health status, and ultimately, health inequalities.


Recruitment information / eligibility

Status Completed
Enrollment 290
Est. completion date June 30, 2022
Est. primary completion date September 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Years and older
Eligibility Inclusion Criteria: - to be18 years old or more in the adult prison and 14 years old or more in the juvenile detention center - to be able to communicate in one of the languages of the study material - to agree to participate in this study. Exclusion Criteria: - presence of an acute psychiatric problem preventing the person from participating in the study

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Audio-visual material
Participants were randomized to receive a paper-based conventional material or to watch a 4-min video. Materials both included legal information required by the Swiss Federal Act on Research involving Human Beings.

Locations

Country Name City State
Switzerland Division of prison health Geneva

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Acceptance to sign the informed consent Binary outcome, legal Swiss document Assessed immediately after intervention
Secondary Understanding of the informed consent Eight self-developed questions assessed as true/false and combined in a 0-8 points score Assessed immediately after intervention
Secondary Evaluation of the informed consent Nine self-developed question assessed on a six-point Likert scale and averaged Assessed immediately after intervention
Secondary Time to read/watch Time in minutes for reading the booklet (the video has a unique duration of 4 min) Assessed immediately after intervention
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