Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06186791
Other study ID # 10894
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 1, 2024
Est. completion date October 1, 2024

Study information

Verified date December 2023
Source Erasmus Medical Center
Contact Fenne Bosma, MA
Phone 0031630933396
Email f.bosma@erasmusmc.nl
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 37500
Est. completion date October 1, 2024
Est. primary completion date March 1, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Netherlands Erasmus University Medical Center Rotterdam

Sponsors (1)

Lead Sponsor Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Chabot BE, Goedhart A. A survey of self-directed dying attended by proxies in the Dutch population. Soc Sci Med. 2009 May;68(10):1745-51. doi: 10.1016/j.socscimed.2009.03.005. Epub 2009 Apr 15. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of annual self-directed deaths 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 Comparison of estimates of self-directed deaths A comparison of current estimates with the estimated numbers of self-directed deaths in 2007 May 2024
Secondary Changes in frequencies An exploration of possible explanations for changes in frequencies May - September 2024
Secondary Decision-making process and quality of dying Providing insight in the decision-making process and the quality of dying of people who choose self-directed dying. June - September 2024
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03754920 - Prolonged Fasting With Meditation and Mild Physical Exercise N/A
Completed NCT05272332 - Gastric Ultrasound Prior to Extubation
Completed NCT04247464 - Short-term Fasting as an Enhancer of Chemotherapy: Pilot Clinical Study on Colorectal Carcinoma Patients N/A
Completed NCT01067001 - Minocycline HCl Extended Release Tablets 135 mg Oral Bioequivalence Study N/A
Completed NCT00757094 - Safety and Feasibility of Fasting While Receiving Chemotherapy N/A
Completed NCT01506713 - Bioequivalence Study of Clopidogrel Tablets 75 mg of Dr. Reddy's Under Fasting Conditions Phase 1
Completed NCT04514380 - Effect of Drinking Carbohydrate-containing Fluids on Gastric Residual Volume in Elderly Patients
Completed NCT05756868 - The Effect of Time-Restricted Feeding on Anthropometry, Biochemical Parameters, Diet Quality and Eating Behavior N/A
Completed NCT05134207 - The Effect of Oral Carbohydrate Solution on Anxiety and Comfort in Patients Undergoing Hip Arthroplasty N/A
Completed NCT05031598 - Long-term Fasting: Multi-system Adaptations in Humans N/A
Recruiting NCT04501393 - Recommended Clear Fluid Intake Volume at 2 Hours Prior to Esophagogastroduodenoscopy for Adult Patients N/A
Enrolling by invitation NCT04027478 - Can Fasting Decrease the Side Effects of Chemotherapy? N/A
Completed NCT05219136 - Improve the Comfort, Safety and Quality of Upper Endoscopy by a Modified Fasting Protocol N/A
Recruiting NCT04625608 - Effect of Premedicant Oral Paracetamol on Gastric Volume and pH Phase 4
Not yet recruiting NCT02562638 - Pre-Procedural Fasting in Cardiac Intervention N/A
Completed NCT01949987 - Does Oral Intake Decreases Postoperative Pain Score in Children N/A
Completed NCT01954836 - Short-Term Fasting During Chemotherapy in Patients With Gynecological Cancer- a Randomized Controlled Cross-over Trial N/A
Completed NCT01746719 - Bioequivalence Study of Etodolac Capsules USP 300 mg Under Fasting Condition Phase 1
Completed NCT01713647 - Bioequivalence Study of Amlodipine / Losartan/ Hydrochlorothiazide of PHARMALINE, Lebanon Under Fastion Conditions Phase 1
Completed NCT01831700 - Bioequivalence Study of Lisinopril and Hydrochlorothiazide Tablets (20+25) mg Under Fasting Conditions Phase 1