Mental Stress Symptoms in Family Caregivers of Palliative Patients

Sponsor
Medical University of Graz (Other)
Overall Status
Recruiting
CT.gov ID
NCT05054647
Collaborator
(none)
100
1
20
5

Study Details

Study Description

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. To investigate whether family caregivers of palliative patients with severe trait anxiety in the care situation also suffer from severe state anxiety.

  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. To investigate the impact of nursing support by a mobile palliative team on family caregivers of palliative patients.

Condition or Disease Intervention/Treatment Phase
  • Other: psychometric questionnaires

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Mental Stress Symptoms in Family Caregivers of Palliative Patients
Actual Study Start Date :
May 1, 2021
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
family caregivers of palliative patients

psychometric questionnaires

Other: psychometric questionnaires
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)

Outcome Measures

Primary Outcome Measures

  1. burn-out syndrome, Outcome is the difference between measurement 1 (Baseline) and measurement 2 (Follow-up) [2 months]

    Maslach Burn-out Inventory (MBI), The MBI does not provide a single score but a profile.

Secondary Outcome Measures

  1. health-related anxiety, Outcome is the difference between measurement 1 (Baseline) and measurement 2 (Follow-up) [2 months]

    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.

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

    State-Trait Anxiety Inventory (STAI). Scores range from 20 to 80, with higher scores correlating with greater anxiety.

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

    Work-related behaviour and experience pattern (AVEM), The AVEM questionnaire does not provide a single score but a profile.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion criteria:
  • Women and men between 18 and 90 years of age

  • Current palliative care situation of a relative with a life-limiting diagnosis.

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

  • Failure to meet the inclusion criteria

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical University of Graz Graz Austria 8036

Sponsors and Collaborators

  • Medical University of Graz

Investigators

  • Principal Investigator: Andreas Baranyi, MD, Medical University of Graz

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT05054647
Other Study ID Numbers:
  • 33-332
  • 33-332
First Posted:
Sep 23, 2021
Last Update Posted:
Sep 23, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 23, 2021