NCT06302283

Brief Summary

The study is a workpackage in the German research consortium COLLPAN. The study will map collateral effects in terms of psychosocial and spiritual burden of informal caregivers during after the pandemic and identification/mapping of risk factors.It will also map available therapeutic and preventive interventions and relief of this burden for the present situation and for future pandemics.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 8, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

March 8, 2024

Status Verified

March 1, 2024

Enrollment Period

9 months

First QC Date

February 21, 2024

Last Update Submit

March 1, 2024

Conditions

Keywords

Informal Caregiver burden

Outcome Measures

Primary Outcomes (4)

  • Bereavement burden

    standardized instrument on bereavement burden (PG- 13)

    Baseline

  • Anxiety

    standardized instrument on anxiety (GAD-7)

    Baseline

  • Depression

    standardized instrument on depression (PHQ-9)

    Baseline

  • Caregiving burden

    standardized instrument on caregiver symptoms (MIDOS-2).

    Baseline

Study Arms (1)

Family Members or Informal Caregivers

family members or informal caregivers that have cared for a patient with Covid-19 or of a patient who has died in the first phase of the pandemic (March to December 2021)

Other: Survey

Interventions

SurveyOTHER

Survey (online or paper) on caregiving burden and bereavement

Family Members or Informal Caregivers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

family members or caregivers that have cared for patients with COVID-19 or have lost a family member in the first phase of the pandemic (March to December 2021)

You may qualify if:

  • having cared for a patient with COVID-19 in the first year of the pandemic (March to December 2021)

You may not qualify if:

  • not fluent in German

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Bonn

Bonn, 53127, Germany

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Lukas Radbruch, MD

    Department of Palliative Medicine, University Hospital Bonn

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Department of Palliative Medicine, University Hospital Bonn

Study Record Dates

First Submitted

February 21, 2024

First Posted

March 8, 2024

Study Start

March 1, 2024

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

March 8, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations