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NCT Number: NCT02861625

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

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.

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Key information

Conditions

Caregivers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut Paoli Calmettes, Marseille, Bouches Du Rhone, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Letter of condolence and post-death medical consultation

Behavioral

Process of sending a letter of condolence with consultation proposition.

Primary outcomes

  1. Evolution of mental component score (MCS) of the SF-12 questionnaire

    Time frame: 3 months post death

    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).

Secondary outcomes

  1. Quality of life of the caregivers after the death of the patient evaluated by specific caregivers CarGOQoL questionnaire

    Time frame: 1 year post death

  2. Quality of life of the caregivers after the death of the patient evaluated by SF12 questionnaire

    Time frame: 1 year post death

  3. Anxiety of the caregivers after the death of the patient

    Time frame: 1 year post death

    Evaluated by Spielberger State Trait anxiety questionnaire

  4. Depression of the caregivers after the death of the patient

    Time frame: 1 year post death

    Evaluated by Hospital Anxiety and Depression Scale

  5. Complicated grief

    Time frame: 1 year post death

    Evaluated by Inventory of complicated grief questionnaire

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Registry information

Official study 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

Acronym: CONDOL01

Important dates

Study start
2018
Primary completion
2023
Study completion
2024
First posted
Aug 10, 2016
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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