Trial document




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  DRKS00010037

Trial Description

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Title

Pilot study on a complex intervention targeting social participation and quality of life of nursing home residents with joint contractures

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Trial Acronym

JointConImprove

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URL of the Trial

http://www.bewegung-verbindet.de

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Brief Summary in Lay Language

Joint contractures are limitations of the full range of motion of a joint and are frequent in older individuals in geriatric care settings. As a result of inactivity, deformity, injury or pain they often lead to restricted mobility and reduced independency in the everyday life of elderly persons. In spite of having far-reaching consequences, joint contractures are scientifically not well understood, neither in the clinical nor in the homecare setting. The Ludwig-Maximilians-University Munich and the Martin Luther University Halle-Wittenberg have developed a complex intervention to improve functioning, social participation and quality of life of concerned persons, called “Contracture Sensitive Care”. The objective of this study is to evaluate the effectiveness and feasibility of the developed intervention “Contracture Sensitive Care” in persons in nursing homes. The participating nursing homes will be assigned randomly to an intervention or control group. In the facilities assigned to the intervention group, “Contracture Sensitive Care” will be implemented in addition to usual care. In the facilities assigned to the control group, brief information session about meaning and consequences of contractures will be given.

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Brief Summary in Scientific Language

Background:
Joint contractures are frequent in older individuals in geriatric care settings. Joint contractures negatively affect quality of life and functioning of involved persons. Rising awareness for this subject in the last years has increased assessment and documentation requirements. The use of preventive measures with unknown effectiveness has increased. The situation of older people suffering from joint contractures in nursing homes needs more scientific awareness, in particular concerning activities of daily living and social participation.

Objective:
The objective of this study is to evaluate the effectiveness and feasibility of a complex intervention to improve social participation of nursing home residents with joint contractures.

Methods:
Overall six nursing homes from two different German regions will be included in this cluster-randomized controlled trial. The primary outcome is social participation of nursing home residents with joint contractures. As secondary outcomes, restrictions in activity, quality of life, activities of everyday life and security measures for residents relating to falls and fall-related fractures will be evaluated. Process evaluation will be conducted using quantitative and qualitative methods.

Expected results:
We expect important knowledge on the acceptance, feasibility and usefulness of our complex intervention. Barriers and facilitators of implementation will be identified. The comparison of the intervention and control group will allow first estimates of the effect size and generate information for the sample size calculation.

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

[---]*

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Description IPD sharing plan:

[---]*

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Organizational Data

  •   DRKS00010037
  •   2016/02/12
  •   [---]*
  •   yes
  •   Approved
  •   2015-164, Ethikkommission der Medizinischen Fakultät der Martin-Luther-Universität Halle Wittenberg
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Secondary IDs

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

  •   M24.50 -  [generalization M24.5: Contracture of joint]
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Interventions/Observational Groups

  •   Intervention group
    Implementation of the “Contracture Sensitive Care” programme through
    • an educational programme (one-day training workshop) and structured support for nominated key nurses;
    • an information session of about 40 minutes to introduce the content of the “Contracture Sensitive Care” programme and the implementation process to all staff members, residents and other stake holders (families, care givers, volunteers);
    • provision of study materials (information brochures for relatives, therapists, physicians); supportive material (poster of interventions` content, checklists, etc.).

  •   Control group
    • optimized usual care: information session about meaning and consequences of contractures, lasting approximately 40 minutes for all staff members and residents
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   assessor, data analyst
  •   Other
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Social participation (instrument: PaArticular Scale (Sub-Skala 2)), developed by the working group in preparatory studies) assessed at baseline, three-month and six-month follow-up

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Secondary Outcome

Activities (instrument: PaArticular Scale (Sub-Skala 2), developed by the working group in preparatory studies), Cognition (Instrument: Dementia Screening Scale) at baseline, three-month and six month follow-up; quality of life (instrument: EQ-5D); activities of daily living (instrument: IADL Skala (Lawton, Brody)); falls and fall-related fractures (resident's record) att baseline and six-month follow-up;
process evaluation to assess feasibility at three-month and six-month follow-up and continuously over the course of the study

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
  •  
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Recruitment

  •   Actual
  •   2016/02/25
  •   150
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Diagnosis joint contracture, informed consent

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Exclusion Criteria

Terminal illness

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Addresses

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    • Martin-Luther-Universität Halle-WittenbergMedizinische Fakultät Institut für Gesundheits- und Pflegewissenschaft
    • Ms.  Professorin  Gabriele  Meyer 
    • Magdeburger Str. 8
    • 06097  Halle
    • Germany
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    • Hochschule Rosenheim, Fakultät für Angewandte Gesundheits- und Sozialwissenschaften
    • Mr.  Professor  Martin  Müller 
    • Hochschulstraße 1
    • 83024  Rosenheim
    • Germany
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    • Martin-Luther-Universität Halle-Wittenberg Institut für Gesundheits- und Pflegewissenschaft
    • Ms.  Katrin  Beutner 
    • Magdeburger Str. 8
    • 06097  Halle /Saale
    • Germany
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    • Institut für Medizinische Informationsverarbeitung, Biometrie und EpidemiologieLudwig-Maximilians-Universität München
    • Ms.  Hanna  Klingshirn 
    • Marchioninistraße 15
    • 81377  München
    • Germany
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    • Martin-Luther-Universität Halle-Wittenberg, Institut für Gesundheits- und Pflegewissenschaft
    • Ms.  Doreen  Grund 
    • Magdeburger Str. 8
    • 06097  Halle /Saale
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Bonn
    • Heinemannstr. 2
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/09/09
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* This entry means the parameter is not applicable or has not been set.