Trial document





This trial has been registered retrospectively.
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  DRKS00012417

Trial Description

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Title

Art therapy as a preventive or interventional treatment for geriatric patients

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Trial Acronym

PAINT

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URL of the Trial

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Brief Summary in Lay Language

The PAINT study investigates the use of art therapy in geriatric patients.
For this purpose the study is divided into two study arms: PAINT I and PAINT II.
In PAINT I, the effect of art therapy (individual therapy on patients) is evaluated with delirium-risk patients in an acute care unit.

In PAINT II, the use of art therapy (group therapy in the creative space) will be evaluated in multimorbid patients of a day clinic.

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Brief Summary in Scientific Language

PAINT is a monocentric randomized controlled cohort study. As an additional part of the multiprofessional geriatric treatment team, the effect of art therapy with multimorbid patients is evaluated. For this purpose the study is divided into two study arms: PAINT I and PAINT II.

PAINT I investigates whether structured art therapy stimulation has a preventive effect on delirium risk patients in an acute care unit or whether it is a non-drug therapy approach with a delir-shortening effect in delirium patients.

PAINT II investigates the effect of art therapy in multimorbid patients with chronic delirium. Pain syndrome, depression or incipient dementia of a geriatric day clinic on the geriatric assessment as well as on the parameters quality of life and well-being. For this purpose, art therapy is offered twice a week in a small group based on the level of brain performance and on a special art therapy concept.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00012417
  •   2020/03/25
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  •   yes
  •   Approved
  •   017/1504, Freiburger Ethik-Kommission International
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Secondary IDs

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Health Condition or Problem studied

  •   Delirium
  •   Chronic pain syndrome, depression, cognitive disorder
  •   F05.9 -  Delirium, unspecified
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Interventions/Observational Groups

  •   In acute geriatric patients, the following is done twice a day until the time of discharge a standardized art therapeutic cognitive stimulation performed by a professional art therapist at the patient's bedside. Through 4AT a daily delir screening is carried out by a trained study nurse.
  •   Delir-risk patients in the control group receive the classic complex treatment of acute geriatrics (treatment-as-usual). Here too, daily delir screening is carried out by a study nurse.
  •   Geriatric patients with cognitive impairments, depression or chronic pain syndrome twice during their stay in the geriatric day clinic. participate in an art therapy session every week. By means of a standardized geriatric assessments (questionnaires and tests), changes in functional, emotional and mental health are assessed and cognitive parameters before and after treatment. Three months after discharge, a telephone interview is conducted to assess the sustainability of the art therapeutic intervention.
  •   Patients in the control group also undergo this assessment and receive treatment as usual.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

PAINT I:
Delirium incidence during the length of stay, measured by 4AT

PAINT II:
Quality of life SF12, pre-post admission and discharge

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Secondary Outcome

PAINT I:
Delir duration (Days with Delir)

PAINT II:
Intervention in geriatric day hospital between admission and discharge (pre-/post):
improvement in geriatric assessment results, Well-Being Index WHO, DIA-S, GDS, VRS

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/10/08
  •   320
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

PAINT I
- Pat. with an age of ≥70 Years
- Written consent of the patient or a legally qualified person (e.g. caregiver)
- positive result in delirious screening or
Pat. with dementia development
- Pat. with degree of care or use of nursing service or nursing home accommodation
- Pat. with previous delirium during previous hospital stays in the own anamnesis

PAINT II
- Pat with an age of ≥70 Years
- written consent of the pat. or a legally competent person
- Pat. with
- Dementia
- Depression or
- chronic. Pain Syndrome

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Exclusion Criteria

PAINT I
- Age ≤ 70 years
- Infectious patients
- Patients in whom CT is not possible for motor or health reasons
- End of life care patients
- Lack of consent
- Language barrier
- (To) transfer

PAINT II
- Age ≤ 70 years
- Patients for whom KT is not possible for motor or health reasons
- Lack of consent
- Language barrier

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Addresses

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    • Klinikum Nürnberg Klinik für Innere Medizin II, Schwerpunkt für Geriatrie
    • Ms.  Prof. Dr. med.  Katrin  Singler 
    • Prof.-Ernst-Nathan-Str.1
    • 90419  Nürnberg
    • Germany
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    • Klinikum Nürnberg, Universitätsklinik der Paracelsus Medizinischen Privatuniversität, Medizinische Klink 2 - Geriatrie
    • Ms.  Prof. Dr. med.  Katrin  Singler, MME 
    • Prof. Ernst-Nathan-Str.1
    • 90419  Nürnberg
    • Germany
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    • Klinikum Nürnberg, Universitätsklinik der Paracelsus Medizinischen Privatuniversität, Medizinische Klink 2 - Geriatrie
    • Ms.  Prof. Dr. med.  Katrin   Singler, MME 
    • Ernst-Nathan-Str. 1
    • 90419  Nürnberg
    • Germany
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Sources of Monetary or Material Support

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    • Staedtler-Stiftung
    • Moosäckerstr. 3
    • 90427  Nürnberg-Boxdorf
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2019/08/08
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Trial Publications, Results and other Documents

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