Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00006800

Trial Description

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Title

Complementary Medicine in Nursing Homes - Mixed Methods Pilot Study

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Trial Acronym

Kneipp Senioren Studie

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URL of the Trial

http://www.zqp.de/index.php?pn=project&id=214

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Brief Summary in Lay Language

The aim of this research project was to gather information about the integration of KT in daily routine care in four Kneipp nursing homes, and to report on the health status of the residents and caregivers who received respectively applied KT. In addition, after the implementation of KT, changes subjectively experienced by residents and caregivers were investigated in the qualitative research component.
One underlying aim of this study was to use the findings as a basis to generate adequate research questions, identify feasible and relevant assessment tools, and gather experience in terms of feasibility for conducting a further study on the effects of KT.

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Brief Summary in Scientific Language

Background: ‘Kneipp Therapy’ (KT) is a form of Complementary and Alternative Medicine (CAM) that includes a combination of hydrotherapy, herbal medicine, mind-body medicine, physical activities, and healthy eating. Since 2007, some nursing homes for older adults in Germany began to integrate CAM in the form of KT in care. The study investigated how KT is used in daily routine care and explored the health status of residents and caregivers involved in KT.
Methods: We performed a cross-sectional pilot study with a mixed methods approach that collected both quantitative and qualitative data in four German nursing homes in 2011. Assessments in the quantitative component included the Quality of Life in Dementia (QUALIDEM), the Short Form 12 Health Survey (SF-12), the Barthel-Index for residents and the Work Ability Index (WAI) and SF-12 for caregivers. The qualitative component addressed the residents’ and caregivers’ subjectively experienced changes after integration of KT. It was conceptualized as an ethnographic rapid appraisal by conducting participant observation and semi-structured interviews in two of the four nursing homes.

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Organizational Data

  •   DRKS00006800
  •   2014/09/25
  •   [---]*
  •   yes
  •   Approved
  •   EA1/147/11, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   The health status of residents and caregivers and in addition the working situation of caregivers in 4 certified Kneipp® - Nursinghomes
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Interventions/Observational Groups

  •   Cross-sectional, mixed methods study to evaluate the health status of approximately 150 residents 30 and caregivers in four certified Kneipp® - Nursing homes and to evaluate the Kneipp Therapy used in this nursing homes and in addition the working and health situation of the caregivers will be evaluated with standardized and non standardized questionaires

    QUALITATIVE COMPONENT
    The study was conducted by ethnographic fieldwork in two Kneipp®-NHs. Data was collected by participant observation (field notes) and by interviewing staff and residents (26 interviews). Data analysis followed the principles of Grounded Theory.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prevention
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Since this is an exploratory observational study, a primary outcome measure was not defined.

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Secondary Outcome

Residents
• Activities of daily living (Barthel-Index)
• Instrumental activities of daily living (IADL)
• Hand Grip Test
• Cognition (Mini Mental Status (MMSE)
• Nutritional condition (MNA-SF)
• Wellbeing („Profile of wellbeing“, German version)
• Quality of Life rated by professional caregivers, Quality of Life in Dementia (SF-12, Qualidem)
• Falls in the last 4 weeks
• Risk of falls (Tinneti Test)
• Intake of drugs
• Health Status (Weight, BMI, diseases, grade of care)
• Use of Kneipp Therapies
• Tolerance of Kneipp Therapies

Caregivers:
• Health status/Work ability (WAI short form)
• Mental stress (COPSOQ short form)
• Quality of Life (SF-12)
• Use of Kneipp Therapies

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
  • other 
  • other 
  • other 
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Recruitment

  •   Actual
  •   2011/09/01
  •   180
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   60   Years
  •   no maximum age
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Additional Inclusion Criteria

Inclusion criteria for residents were an age of at least 60 years, written and oral informed consent (for those under legal guardianship, guardians had to provide consent) and regular (daily or weekly) individualised KT for at least 3 months. Inclusion criteria for caregivers were an age of at least 18 years, written and oral informed consent, regular and routine delivery of KT in the nursing home for at least 3 months, and at least 3 years general professional experience.

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Exclusion Criteria

Residents:
Severe chronic or acute physical or mental illness, which do not provide a survey of the planned outcome parameters, participation in another study within the last 6 month
Caregivers:
Severe chronic or acute physical or mental illness, which do not provide a survey of the planned outcome parameters, participation in another study within the last 6 month

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Addresses

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    • Zentrum für Qualität in der Pflege (ZQP)
    • Reinhardtstr. 45
    • 10117  Berlin
    • Germany
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    •   00493027593950
    •   [---]*
    •   info at zqp.de
    •   [---]*
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    • Kneipp-Bund e.V.
    • Axel-Springer-Str. 54b
    • 10117  Berlin
    • Germany
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    • Institut f. Sozialmedizin, Epidemiologie u. Gesundheitsökonomie, Charité - Universitätsmedizin Berlin
    • Ms.  Dr.  Miriam  Ortiz 
    • Luisenstr. 57
    • 10117  Berlin
    • Germany
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    • Institut f. Sozialmedizin, Epidemiologie u. Gesundheitsökonomie, Charité - Universitätsmedizin Berlin
    • Ms.  Margit  Cree 
    • Luisenstr. 57
    • 10117  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Zentrum für Qualität in der Pflege (ZQP)
    • Reinhardtstr. 45
    • 10117  Berlin
    • Germany
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    •   00493027593950
    •   [---]*
    •   info at zqp.de
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2011/12/31
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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.