Collateral Effects of Pandemics - Care for Informal Caregivers

Bereavement Clinical Trial

— COLLPAN-3A  

Official title:

Collateral Effects of Pandemics - Care for Informal Caregivers

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06302283
• Other study ID #: 114/23-EP
• Status: Enrolling by invitation
• Start date: March 2024
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: University of Bonn
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

a scoping literature review will compile evidence on informal caregiver burden during and after the pandemic (PubMed, PsychInfo, Cochrane Database). The aim of the review is to gain knowledge on frequency, severity, source and circumstances of care givers' burden and to identify research and supportive gaps.

The study will recruit family members and care givers of patients with COVID-19 or long-COVID as well as bereaved family members and care givers of patients who have died during the pandemic in order to assess severity of burden. Recruitment will be done in collaboration with the German Association of Undertakers and the Federal Association for Bereavement Care. Family members and caregivers will be asked to complete a survey with instruments on bereavement burden (PG- 13), distress (PHQ-9; GAD-7) and care giver symptoms (IPOS; MIDOS-2). The survey will be available online (using SoSciSurvey platform) or as a paper and pencil version. Survey participants will be invited to in-depth interviews.

Recruitment of 200 participants each for caregiving of COVID-19 patients and bereaved family members will be targeted. Interviews are planned with 30 participants in each group or until saturation is reached.

Based on findings, recommendations on interventions to support family care givers will be developed

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 400
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• not fluent in German

Related Conditions & MeSH terms

• Bereavement

Intervention

Other:
• Survey
Survey (online or paper) on caregiving burden and bereavement

Locations

Country	Name	City	State
Germany	University Hospital Bonn	Bonn

Sponsors (4)

Lead Sponsor	Collaborator
University of Bonn	Johannes Gutenberg University Mainz, Universitätsklinikum Hamburg-Eppendorf, Wuerzburg University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bereavement burden	standardized instrument on bereavement burden (PG- 13)	Baseline
Primary	Anxiety	standardized instrument on anxiety (GAD-7)	Baseline
Primary	Depression	standardized instrument on depression (PHQ-9)	Baseline
Primary	Caregiving burden	standardized instrument on caregiver symptoms (MIDOS-2).	Baseline