- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06186791
Self-directed Dying in the Netherlands
Self-directed Dying in the Netherlands by Voluntarily Stopping Eating and Drinking or Independently Intake of Lethal Medication Attended by a Confidant.
In 2007, the frequency of so-called 'self-directed dying' in the Netherlands was investigated, that is, the voluntary cessation of eating and drinking or the taking of lethal self-collected medication. This research has not been repeated yet. Since 2007 there have been major developments regarding assisted and non-assisted dying, including the issue of a guideline by the KNMG and the endorsement by various political parties of a proposal for a new law on assistance in dying. There has also been much societal debate on euthanasia and assisted suicide as regulated by the Termination of Life on Request and Assisted Suicide (Review Procedures) Act. These developments may have had an influence on the frequency of self-directed dying.
The primary objective of this cross-sectional questionnaire study with add-on qualitative interviews is to estimate how many people die each year in the Netherlands by either voluntarily stopping eating or drinking (VSED) or intentional intake of lethal medication attended by a confidant (ILMC). Secondary objectives include studying whether this number has changed since 2007; exploring possible explanations for changes in frequencies; and providing insight in the quality of dying of people who choose self-directed dying.
To this end an online questionnaire will be sent out to a randomly drawn sample (n ≈ 37 500) from a large representative panel (NIPObase) of the Dutch adult population. A two-stage screening procedure will be used to check whether the experiences of the respondents represent a death VSED or by ILMC. The data will be analysed using quantitative software SPSS. From the respondents who indicate that they are willing to be interviewed, a sample will be taken from each group, 20 from VSED and 20 from ILMC. Interviews will be conducted by an experienced interviewer. The interviews are focused on better understanding people's choice for a self-directed death and on the perceived quality of the dying process for both methods. The interviews will be audio recorded and thematically analysed using qualitative software (N-Vivo).
Study Overview
Status
Conditions
Detailed Description
The frequency of both types of self-directed deaths in the population can be estimated with the standard weighting method that is used by Statistics Netherlands (CBS) in estimating the annual frequency of relatively rare events such as traffic incidents. The investigators will use an adapted standard weighting. Each informant is weighted by the inverse of 1 (the informant) plus the number of other individuals who had been confided by the deceased person about their intention to hasten death by VSED or ILMC. The estimated number of cases will be computed for the responding part of the sample. For the frequency estimation, the investigators will use the number of informants on a death by VSED or ILMC in the five years from 1 January 2018 to 31 December 2022, because reports about cases before 2018 are considered less reliable. The annual frequency of VSED and ILMC can then be computed as the estimated proportion of reported cases in the sample (i.e. weighted sum of informants on VSED deaths and ILMC deaths respectively divided by sample size corrected for non-response), multiplied by the total number of Dutch adults minus non-western adults (underrepresented in the sample) and divided by the five years covered by the informants. The Poisson distribution will be used in calculating the 95% Confidence Intervals (CIs).
Secondary outcomes will be mainly described in frequency tables, using standard statistical analysis.
The interview transcripts will be analysed thematically using NVivo software.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Fenne Bosma, MA
- Phone Number: 0031630933396
- Email: f.bosma@erasmusmc.nl
Study Locations
-
-
-
Rotterdam, Netherlands, 3015GD
- Erasmus University Medical Center
-
Contact:
- Fenne Bosma, MA
- Phone Number: 0031630933396
- Email: f.bosma@erasmusmc.nl
-
Contact:
- Agnes van der Heide, Prof. dr.
- Email: a.vanderheide@erasmusmc.nl
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Be 18 years or older
- Be able to speak and read Dutch
- Have given informed consent to participation
Exclusion Criteria:
- Younger than 18 years
- Not able to speak and read Dutch
- Not giving informed consent to participation
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of annual self-directed deaths
Time Frame: January 2024 - March 2024
|
An estimate of the number of people who die each year by voluntary stopping eating and drinking, and an estimate of the number of people who die each year by independent intake of lethal medication attended by a confidant.
|
January 2024 - March 2024
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of estimates of self-directed deaths
Time Frame: May 2024
|
A comparison of current estimates with the estimated numbers of self-directed deaths in 2007
|
May 2024
|
Changes in frequencies
Time Frame: May - September 2024
|
An exploration of possible explanations for changes in frequencies
|
May - September 2024
|
Decision-making process and quality of dying
Time Frame: June - September 2024
|
Providing insight in the decision-making process and the quality of dying of people who choose self-directed dying.
|
June - September 2024
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Agnes van der Heide, prof. dr., Erasmus Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10894
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Fasting
-
USDA, Western Human Nutrition Research CenterUniversity of California, DavisCompletedCardiovascular Risk Factor | Athletic Performance | Fasting | Resting Energy Expenditure | Intermittent FastingUnited States
-
Desitin Arzneimittel GmbHBioPharma Services, IncCompleted
-
Beth Israel Deaconess Medical CenterCompleted
-
Gaziosmanpasa Research and Education HospitalCompleted
-
Postgraduate Institute of Medical Education and...Completed
-
Chulalongkorn UniversityCompleted
-
IPCA Laboratories Ltd.Completed
-
IPCA Laboratories Ltd.Completed
-
Dr. Reddy's Laboratories LimitedCompleted