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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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02861625
Acronym
CONDOL01
Enrollment
432
Registered
2016-08-10
Start date
2018-05-24
Completion date
2024-08-11
Last updated
2026-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caregivers

Brief 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.

Detailed 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.

Interventions

BEHAVIORALLetter of condolence and post-death medical consultation

Process of sending a letter of condolence with consultation proposition.

Sponsors

Institut Paoli-Calmettes
Lead SponsorOTHER

Study design

Observational model
FAMILY_BASED
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Evolution of mental component score (MCS) of the SF-12 questionnaire3 months post deathIt 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).

Secondary

MeasureTime frameDescription
Quality of life of the caregivers after the death of the patient evaluated by specific caregivers CarGOQoL questionnaire1 year post death
Quality of life of the caregivers after the death of the patient evaluated by SF12 questionnaire1 year post death
Anxiety of the caregivers after the death of the patient1 year post deathEvaluated by Spielberger State Trait anxiety questionnaire
Depression of the caregivers after the death of the patient1 year post deathEvaluated by Hospital Anxiety and Depression Scale
Complicated grief1 year post deathEvaluated by Inventory of complicated grief questionnaire

Countries

France

Contacts

PRINCIPAL_INVESTIGATORGwenaelle Gravis, MS

Institut Paoli-Calmettes

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 9, 2026