BereavementCOLLPAN-3ANCT06302283
Collateral Effects of Pandemics - Care for Informal Caregivers
An observational study of Bereavement, run by University of Bonn at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bereavement
- What is being tested?
- Survey
- How many people
- 400 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2024to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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)
Who may be able to join
- having cared for a patient with COVID-19 in the first year of the pandemic (March to December 2021)
Who cannot join
- not fluent in German
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Bereavement
- Being tested
- Survey
- Keywords
- Informal Caregiver burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Survey (online or paper) on caregiving burden and bereavement
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bereavement burden
standardized instrument on bereavement burden (PG- 13)
Measured: Baseline
Anxiety
standardized instrument on anxiety (GAD-7)
Measured: Baseline
Depression
standardized instrument on depression (PHQ-9)
Measured: Baseline
Caregiving burden
standardized instrument on caregiver symptoms (MIDOS-2).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study startMar 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BereavementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bonn
- Sponsor type
- University, hospital or other
- Collaborators
- Wuerzburg University Hospital, Johannes Gutenberg University Mainz, Universitätsklinikum Hamburg-Eppendorf
- Responsible party
- Principal investigator, Lukas Radbruch, University of Bonn
- Investigators
- Lukas Radbruch, MD, Principal investigator, Department of Palliative Medicine, University Hospital Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06302283
- Sponsor's protocol ID
- 114/23-EP
- Acronym
- COLLPAN-3A
- Status last verified
- Mar 2024
- First submitted
- 21 Feb 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collateral Effects of Pandemics - Care for Informal Caregivers
- ClinicalTrials.gov ID
- NCT06302283
- Acronym / sponsor ID
- COLLPAN-3A / 114/23-EP
- Conditions
- Bereavement
- Keywords
- Informal Caregiver burden
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of BonnUniversity, hospital or other
- Collaborators
- Wuerzburg University Hospital, Johannes Gutenberg University Mainz, Universitätsklinikum Hamburg-Eppendorf
- Study start
- Mar 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Family Members or Informal Caregivers | – | Other: Surveyfamily 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (1 listed)
- having cared for a patient with COVID-19 in the first year of the pandemic (March to December 2021)
Key exclusion criteria (1 listed)
- not fluent in German
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveySurvey (online or paper) on caregiving burden and bereavement | Other | Family Members or Informal Caregivers |
Primary outcome
Bereavement burden
Time frame: Baseline
standardized instrument on bereavement burden (PG- 13)
Anxiety
Time frame: Baseline
standardized instrument on anxiety (GAD-7)
Depression
Time frame: Baseline
standardized instrument on depression (PHQ-9)
Caregiving burden
Time frame: Baseline
standardized instrument on caregiver symptoms (MIDOS-2).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lukas Radbruch, MD principal investigator
Department of Palliative Medicine, University Hospital Bonn
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bereavement, run by University of Bonn at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bereavement burden (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.