Clinical trial NCT06302283: Collateral Effects of Pandemics - Care for Informal Caregivers
Official title: Collateral Effects of Pandemics - Care for Informal Caregivers
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Bereavement
Keywords: Informal Caregiver burden
Lead sponsor: University of Bonn
Sponsor class: OTHER
Collaborators: name: Wuerzburg University Hospital
name: Johannes Gutenberg University Mainz
name: Universitätsklinikum Hamburg-Eppendorf
First posted: 2024-03-08
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_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)

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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Bereavement burden
timeFrame: Baseline
measure: Anxiety
timeFrame: Baseline
measure: Depression
timeFrame: Baseline
measure: Caregiving burden
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University Hospital Bonn
Study officials:
affiliation: Department of Palliative Medicine, University Hospital Bonn
name: Lukas Radbruch, MD
role: PRINCIPAL_INVESTIGATOR
References: