NCT05054647

Brief 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. Caregiving is often an extreme physical challenge, but above all a psychological one. Aims of the study

  1. 1.To investigate whether family caregivers of palliative patients with severe trait anxiety in the care situation also suffer from severe state anxiety.
  2. 2.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.
  3. 3.To investigate the impact of nursing support by a mobile palliative team on family caregivers of palliative patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 23, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

January 11, 2023

Status Verified

January 1, 2023

Enrollment Period

2.7 years

First QC Date

June 30, 2021

Last Update Submit

January 10, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 months

Secondary Outcomes (3)

  • health-related anxiety, Outcome is the difference between measurement 1 (Baseline) and measurement 2 (Follow-up)

    2 months

  • State/Trait anxiety, Outcome is the difference between measurement 1 (Baseline) and measurement 2 (Follow-up)

    2 months

  • Work-related behaviour and experience pattern, Outcome is the difference between measurement 1 (Baseline) and measurement 2.

    2 months

Study Arms (1)

family caregivers of palliative patients

psychometric questionnaires

Other: psychometric questionnaires

Interventions

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)

family caregivers of palliative patients

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Family caregivers of palliative patients

You may qualify if:

  • Women and men between 18 and 90 years of age
  • Current palliative care situation of a relative with a life-limiting diagnosis.

You may not qualify if:

  • Persons incapable of giving consent (e.g. dementia, delirium, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Graz

Graz, 8036, Austria

RECRUITING

Study Officials

  • Andreas Baranyi, MD

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas Baranyi, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2021

First Posted

September 23, 2021

Study Start

May 1, 2021

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

January 11, 2023

Record last verified: 2023-01

Locations