Family CaregiversNCT05054647
Mental Stress Symptoms in Family Caregivers of Palliative Patients
An observational study of Family Caregivers and Palliative Patients, run by Medical University of Graz at 1 site in Austria.
Trial summary
Receiving a life-limiting diagnosis is often a shock for those affected as well as for their relatives, which changes the entire life situation of the family. New perspectives often arise, as well as feelings of worry, sadness and powerlessness. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Family Caregivers, Palliative Patients
- What is being tested?
- psychometric questionnaires
- How many people
- 100 participants
- Where
- 1 siteAustria
- Study dates
- 1 May 2021to 1 Jan 2024
- How long will I take part?
- 2 Months
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Family caregivers of palliative patients
Who may be able to join
- Women and men between 18 and 90 years of age
- Current palliative care situation of a relative with a life-limiting diagnosis.
Who cannot join
- Persons incapable of giving consent (e.g. dementia, delirium, etc.)
- Failure to meet the inclusion criteria
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Graz
Graz, 8036
Andreas Baranyi, M.D., 0043-316-385-86241, an.baranyi@medunigraz.at
About this study
Receiving a life-limiting diagnosis is often a shock for those affected as well as for their relatives, which changes the entire life situation of the family. New perspectives often arise, as well as feelings of worry, sadness and powerlessness. Caregiving is often an extreme physical challenge, but above all a psychological one.
Aims of the study
- To investigate whether family caregivers of palliative patients with severe trait anxiety in the care situation also suffer from severe state anxiety.
- To investigate whether family caregivers of palliative patients with increased stress levels and burnout-promoting work-related behaviour suffer more from burnout symptoms, health-related anxiety and psychosomatic complaints.
- To investigate the impact of nursing support by a mobile palliative team on family caregivers of palliative patients.
- Conditions
- Family Caregivers, Palliative Patients
- Being tested
- psychometric questionnaires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychometric questionnairesOther
Perceived Stress Scale (PSS-10); Trier-Inventory on Chronic Stress; State/Trait Anxiety Inventory (STAI); AVEM-Work-related behaviour and experience pattern; Maslach Burn-out Inventory - Human Services Survey (MBI - HSS) health-related anxiety: Whiteley Index (WI)
| Study group | Role | What they receive |
|---|---|---|
| family caregivers of palliative patients | psychometric questionnaires Receives: Other: psychometric questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
burn-out syndrome, Outcome is the difference between measurement 1 (Baseline) and measurement 2 (Follow-up)
Maslach Burn-out Inventory (MBI), The MBI does not provide a single score but a profile.
Measured: 2 months
Secondary outcomes (3)
health-related anxiety, Outcome is the difference between measurement 1 (Baseline) and measurement 2 (Follow-up)
Whiteley Index/Illness Attitude Scale (WI-IAS). Whitely-Index: The Whitely-Index is formed by the sum of the points for each answer - the higher the score, the more likely one is to be hypochondriacal.
IAS: The total score ranges from 0 to108.
Measured: 2 months
State/Trait anxiety, Outcome is the difference between measurement 1 (Baseline) and measurement 2 (Follow-up)
State-Trait Anxiety Inventory (STAI). Scores range from 20 to 80, with higher scores correlating with greater anxiety.
Measured: 2 months
Work-related behaviour and experience pattern, Outcome is the difference between measurement 1 (Baseline) and measurement 2.
Work-related behaviour and experience pattern (AVEM), The AVEM questionnaire does not provide a single score but a profile.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study start1 May 2021
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family CaregiversStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Baranyi, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05054647
- Sponsor's protocol ID
- 33-332
- Other IDs
- 33-332
- Status last verified
- Jan 2023
- First submitted
- 30 Jun 2021
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Stress Symptoms in Family Caregivers of Palliative Patients
- ClinicalTrials.gov ID
- NCT05054647
- Acronym / sponsor ID
- 33-332
- Conditions
- Family Caregivers, Palliative Patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 23 Sep 2021 (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.
Receiving a life-limiting diagnosis is often a shock for those affected as well as for their relatives, which changes the entire life situation of the family. New perspectives often arise, as well as feelings of worry, sadness and powerlessness. Caregiving is often an extreme physical challenge, but above all a psychological one.
Aims of the study
- To investigate whether family caregivers of palliative patients with severe trait anxiety in the care situation also suffer from severe state anxiety.
- To investigate whether family caregivers of palliative patients with increased stress levels and burnout-promoting work-related behaviour suffer more from burnout symptoms, health-related anxiety and psychosomatic complaints.
- To investigate the impact of nursing support by a mobile palliative team on family caregivers of palliative patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| family caregivers of palliative patients | – | Other: psychometric questionnairespsychometric questionnaires |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Family caregivers of palliative patients
Key inclusion criteria (2 listed)
- Women and men between 18 and 90 years of age
- Current palliative care situation of a relative with a life-limiting diagnosis.
Key exclusion criteria (2 listed)
- Persons incapable of giving consent (e.g. dementia, delirium, etc.)
- Failure to meet the inclusion criteria
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 |
|---|---|---|
| psychometric questionnairesPerceived Stress Scale (PSS-10); Trier-Inventory on Chronic Stress; State/Trait Anxiety Inventory (STAI); AVEM-Work-related behaviour and experience pattern; Maslach Burn-out Inventory - Human Services Survey (MBI - HSS) health-related anxiety: Whiteley Index (WI) | Other | family caregivers of palliative patients |
Primary outcome
burn-out syndrome, Outcome is the difference between measurement 1 (Baseline) and measurement 2 (Follow-up)
Time frame: 2 months
Maslach Burn-out Inventory (MBI), The MBI does not provide a single score but a profile.
3 secondary outcomes
health-related anxiety, Outcome is the difference between measurement 1 (Baseline) and measurement 2 (Follow-up)
Time frame: 2 months
State/Trait anxiety, Outcome is the difference between measurement 1 (Baseline) and measurement 2 (Follow-up)
Time frame: 2 months
Work-related behaviour and experience pattern, Outcome is the difference between measurement 1 (Baseline) and measurement 2.
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Individual participant dataSharing planned: Undecided
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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.
Andreas Baranyi, MD principal investigator
Medical University of Graz
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 Family Caregivers and Palliative Patients, run by Medical University of Graz at 1 site in Austria.
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 2 inclusion and 2 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 11 Jan 2023. 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 Austria. 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?
Contact Andreas Baranyi, MD (004331638586241, an.baranyi@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
burn-out syndrome, Outcome is the difference between measurement 1 (Baseline) and measurement 2 (Follow-up) (time frame: 2 months). 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 11 Jan 2023.