Trial document




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  DRKS00006347

Trial Description

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Title

Improvement of quality of life / life satisfaction of patients with chronic diseases with respect to their spiritual needs

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

In the context of chronic or life-changing / limiting diseases, most patients are confronted with the question of purpose and meaning in life. What carries them, and what gives them hope? Patients use spirituality / religiosity as an important resource for handling the chronic disease. In the clinical context, these resources are mostly not taken account of though.
The goal of this research is to answer the following question: To what extent does the quality and satisfaction of life improve for chronically ill patients by considering their spiritual needs?
Patients and staff of Palliative Medical Institutions will be interviewed.
The study consists of three steps.
Step 1
-> Inquiry/Survey: Patients
-> Anonymous communication of results: Team / Responses to expressed needs, options for action
-> Inquiry/ Survey: Employee
Step 2
-> Volunteer- training
Step 3
-> Inquiry / Survey: Patient
-> Anonymous communication of results: Team / responses to expressed needs, options for action
-> Inquiry / Survey: Employee

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Brief Summary in Scientific Language

please see Brief summery in lay language

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Organizational Data

  •   DRKS00006347
  •   2014/07/30
  •   [---]*
  •   yes
  •   Approved
  •   316/14, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   Quality of life / statisfaction of patients with chronic diseases with respect to their spiritual needs
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Interventions/Observational Groups

  •   Patients and staff of Palliative Medical Institutions will be interviewed.
    The study consists of three steps.
    Step 1
    -> Inquiry/Survey: Patients
    -> Anonymous communication of results: Team / Responses to expressed needs, options for action
    -> Inquiry/ Survey: Employee
    Step 2
    -> Volunteer- training
    Step 3
    -> Inquiry / Survey: Patient
    -> Anonymous communication of results: Team / responses to expressed needs, options for action
    -> Inquiry / Survey: Employee
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The experience of the patients (m / f) themselves is the primary interest and objective goal criterion.
For patients:
- Questionnaires are filled out at the beginning of the hospital stay and at the time of inpatient discharge (after two weeks at the latest)
- Used standardized questionnaire instruments:
>Spiritual needs (SpNQ)
>Quality of life / satisfaction (POS + BMLSS)
>Spiritual well-being (FACIT-Sp)
>Attunement (ASTS, English version POMS)
>Perception of stress (PSS)
>Symptom Scale (VAS)
>Perceived support / being cared for by the team (single-item, only in the post-questionnaire)
>Socio-demographic data

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Secondary Outcome

1. How does a specific (voluntary) training program, that includes practical and mediative exercise and educational interest, influence motivation and job satisfaction?
2. Can the training program impart/develop employee competences, that result directly in increased quality of life/satisfaction of the treated patient (independent of the basic disease) and in the support of spiritual needs?
3. How does the therapeutic team deal with the spiritual needs articulated by the patient (documented by standardized questionnaire, SpNQ) and which reactions take place in order to respond to them?
4. Does the therapeutic relationship change through the sensibility for and the knowledge of the patients spiritual needs and is this change perceptible to the patient in a positive sense?
5. Can the basic ability to respond to a patients spiritual need (documented in step 1) be increased by the training program in terms of skills aquisition on the employees part?
6. Which aspects of spirituality are associated with higher life satisfaction, self-efficacy expectancy and a lower perception of stress and distance in the therapeutic relationship on the employees part?

For Employees:
- The questionnaires are filled out at the beginning of each 6-month observation phase as well as the end.
- Used standardized questionnaire instruments:
>Living and team satisfaction
>Work Engagement (POS + BMLSS)
>Self-efficacy expectation (SWE)
>Perception of stress (PSS)
>Distancing in the therapeutic relationship (Cool down index)
>Generative altruism (GAIS)
>Expression of spirituality (ASP or SpREUK-P)
>Responsibility for spiritual needs (individual items)
>Socio-demographic data

- Qualitative interviews of employees:
1. How did the team handle the patients spiritual needs?
2. What specific reactions were carried out in terms of support?
3. How did the patient respond to the offers of the team / the individual person?
4. Did the therapeutic relationship change?

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2014/10/22
  •   100
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

- Active patient contact in the appropriate facility
- Age between 18 - 65
- Written consent to participate in the survey

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Exclusion Criteria

- Manifest mental illness from the ICD 10 - Symptom groups F0 - F5

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Addresses

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    • Lehrstuhl für PalliativmedizinÄrztliche Direktorin Klinik für PalliativmedizinUniversitätsklinikum Freiburg
    • Ms.  Prof.Dr.med.Dipl.-Theol.Dipl.-Caritaswiss.  Gerhild  Becker 
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • Germany
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    • Theologische Fakultät der Albert-Ludwigs-Universität Freiburg
    • Mr.  Univ.-Prof.Dr.Theol.  Klaus  Bauman 
    • Platz der Universität 3
    • 79098  Freiburg
    • Germany
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    •   +49 761 2032110
    •   +49 761 2032119
    •   [---]*
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    • Institut für Integrative MedizinFakultät für Gesundheit der Universität Witten/Herdecke
    • Mr.  Univ.-Prof.Dr.med.  Arndt  Büssing 
    • Gerhard-Kienle-Weg 4
    • 58313  Herdecke
    • Germany
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    • Institut für Integrative MedizinFakultät für Gesundheit der Universität Witten/Herdecke
    • Mr.  Univ.-Prof.Dr.med.  Arndt  Büssing 
    • Gerhard - Kienle - Weg 4
    • 58313  Herdecke
    • Germany
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Sources of Monetary or Material Support

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    • Lehrstuhl für PalliativmedizinÄrztliche Direktorin Klinik für PalliativmedizinUniversitätsklinikum Freiburg
    • Ms.  Prof.Dr.med.Dipl.-Theol.Dipl.-Caritasswiss.  Gerhild  Becker 
    • Robert-Koch-Starsse 3
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.