CONDOL01: Evaluation on the Experience of Bereavement, of a Medical Consultation, Proposed by a Letter of CONDOLence to the Patients' Relatives Versus Standard Practice After the Death of the Patient

Caregivers Clinical Trial

— CONDOL01  

Official title:

CONDOL01: Evaluation on the Experience of Bereavement, of a Medical Consultation, Proposed by a Letter of CONDOLence to the Patients' Relatives Versus Standard Practice After the Death of the Patient: A Multicenter, Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02861625
• Other study ID #: CONDOL01-IPC 2015-006
• Status: Recruiting
• Start date: May 24, 2018
• Est. completion date: June 4, 2022

Study information

• Verified date: January 2020
• Source: Institut Paoli-Calmettes
• Contact: Dominique Genre, MD
• Phone: 0033491223778
• Email: drci.up[@]ipc.unicancer.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this randomized multicenter study is to evaluate the impact in offering the condolence letter to the family caregivers (indicated as the reliable person by the patient himself at each hospitalization) and a bereavement consultation with the reference physician.

Description:

The hypothesis is that offering the opportunity to clarify questions about the patients' terminal care will influence positively the grieving process. In particular, the study team hypothesized that psychological morbidity will be reduced (main objective) as well as some aspects of QOL (secondary objective). It is also assumed that the situations of conflict (solicitations for medical records, number of legal procedures) will be reduced.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 432
• Est. completion date: June 4, 2022
• Est. primary completion date: June 4, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient died in the institution

• Patient for which the reliable person has been identified

• Acceptation of the reference physician to send a letter of condolence with the proposed consultation

Exclusion Criteria:

• The physician already met with the caregiver after the patient's death

Related Conditions & MeSH terms

• Caregivers

Intervention

Behavioral:
• Letter of condolence and post-death medical consultation
Process of sending a letter of condolence with consultation proposition.

Locations

Country	Name	City	State
France	GRAVIS	Marseille
France	Institut Paoli Calmettes	Marseille	Bouches Du Rhone

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of mental component score (MCS) of the SF-36 questionnaire	It will be evaluated by self-questionnaires send at 3 months after the death of the patient, in the 2 groups (with or without condolence letter proposing a post-death consultation).	3 months post death
Secondary	Quality of life of the caregivers after the death of the patient evaluated by specific caregivers CarGOQoL questionnaire		1 year post death
Secondary	Quality of life of the caregivers after the death of the patient evaluated by SF36 questionnaire		1 year post death
Secondary	Anxiety of the caregivers after the death of the patient	Evaluated by Spielberger State Trait anxiety questionnaire	1 year post death
Secondary	Depression of the caregivers after the death of the patient	Evaluated by Hospital Anxiety and Depression Scale	1 year post death
Secondary	Complicated grief	Evaluated by Inventory of complicated grief questionnaire	1 year post death