Trial document

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Trial Description

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The effectiveness of occupational therapy at home in persons with dementia and their primary caregiver - a multicentre randomised controlled trial evaluating the Dutch occupational therapy programme within the German context.

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Trial Acronym


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URL of the Trial

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Brief Summary in Lay Language

This study evaluates the effectiveness of occupational therapy at home in 140 couples of persons with dementia and their relatives. Aims of the study are improvements of the everyday activities and quality of life and a better interaction of the relatives and their affected partners.

Two alternative treatments are offered. One alternative comprises medical routine care plus a consultation by an occupational therapist at the patient's home by means of an information brochure. The other treatment alternative includes medical routine care plus ten home visits by an occupational therapist. The brochure is based on the guidebook of the German Alzheimer Society called "Guidebook: Home Care for Persons with Dementia". The home visit programme is based on the Dutch manual by Graff and Colleagues for occupational therapy in dementia, in which the relatives are instructed to offer appropriate assistance for their affected partners and to arrange everyday life in a way that independent activity and participation in social life is possible. Together with patients and relatives, therapists improve selected everyday activities in a way that patients can do it themselves even if they suffer from cognitive limitations.

Following data are collected: (1) Grade of dementia and further diseases before starting treatment programmes, (2) competence in everyday life of the patient, interaction between relative and patient as well as quality of life and mood before treatment, directly thereafter and after four and six month, (3) possible admission to nursing homes after four and six month and (4) costs and acceptance of intervention as well as rates of and reasons for drop out.

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Brief Summary in Scientific Language

Objectives: To compare the effects of an occupational therapy home programme and an occupational therapy home consultation on occupational performance and quality of life of persons with mild and moderate dementia, on quality of life and sense of competence of their primary caregivers and on health care costs.

Design: Single blind randomised controlled trial with seven centres, 5 weeks intervention period, pre-post assessment and follow up assessment at week 16, 26 and 52. Study period from September 2008 to February 2010.

Participants: Persons with mild and moderate dementia, living at home together with a primary caregiver caring at least twice a week for the patient.

Inclusion criteria: Alzheimers disease incl. mixed dementia (ICD-10-F00), Minimental State Examination Score: 14 to 24.

Exclusion criteria: Geriatric Depression Scale (30 Items) Score: > 12, severe need of nursing care, instable medical conditions, severe behavioural disturbances.

Interventions: 10 home visits by a trained occupational therapist, in order to support the successful performance of meaningful everyday activities of patient and caregiver versus 1 home consultation by a trained occupational therapist based on information material of the Alzheimer Society, in order to support caregiver and patient in the utilisation of resources in the community.

Outcome: Occupational performance of the patient, quality of life of patient and caregiver, sense of competence of the caregiver, mood of patient and caregiver, acceptance of intervention by patient and caregiver, resource utilisation of patient and caregiver, and time and kind of informal care by the primary caregiver.

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Organizational Data

  •   DRKS00000053
  •   2008/11/14
  •   2008/06/27
  •   yes
  •   Approved
  •   110/08, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   UKF001627  (Register klinischer Studien des Universitätsklinikums Freiburg)
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Health Condition or Problem studied

  •   F00 -  Dementia in Alzheimer's disease
  •   [---]* -  [---]*
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Interventions/Observational Groups

  •   The intervention of study arm 1 consists of an evidence-based community occupational therapy programme including 10 sessions occupational therapy at home. Providers are occupational therapists experienced in treatment of cognitively impaired older people and trained in the programme. 'Community' indicates that occupational therapy intervention occurs in the person's own home.
  •   The intervention in study arm 2 consists of one community occupational therapy consultation based on information material of the Alzheimer Society. Providers are occupational therapists experienced in treatment of cognitively impaired older people and trained in this special consultation. 'Community' indicates that occupational therapy intervention occurs in the person's own home.
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  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   assessor, data analyst
  •   Active control
  •   Other
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

Patients functioning in daily life and quality of life

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Secondary Outcome

Cargiver`s quality of life and competence of interaction with the patient
Participants satisfaction with the intervention
Health care costs on societal level

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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  •   Actual
  •   2008/08/20
  •   140
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Alzheimer dementia (ICD-10 - F00)
MMSE 14-24
Living at home

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Exclusion Criteria

Geriatric depression scale (30 Items) > 12, Major need for nursing care, Severe behavioural disturbances, Unstable general medical condition

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Sources of Monetary or Material Support

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    • Bundesministerium für Gesundheit
    • Rochusstr. 1
    • 53123  Bonn
    • Germany
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  •   Recruiting complete, follow-up complete
  •   2010/08/31
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* This entry means the parameter is not applicable or has not been set.