Alzheimer Disease : Rehabilitation's Intervention at Home

Study Overview
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Brief Summary
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Alzheimer's disease (AD) is the most common cause of dementia among elderly patients. By its prevalence and its medical and social consequences, AD represents a dual challenge to public health and society. The elderly want to stay in their homes even when their lives are altered by a chronic progressive disease. Their caregivers claim in turn a support at home. But this desire is questioned because of the characteristics of the disease, e.g. the altered relational function by the cognitive impairment and the behavioural disorders associated. Outpatients non-drug therapies represent a potential support that adapts to patient with an AD or mixed dementia, especially in their milder forms. The aim of the study is to evaluate the feasibility of a weekly rehabilitation's intervention at home and its acceptability by both the patient and the caregiver. The study of its efficiency in terms of autonomy will be the next step.

Detailed Description
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The protocol is based on weekly rehabilitation's intervention at home. All home visits and assessments of the patient and his caregiver will be made by the rehabilitation's therapist himself. Twelve weekly interventions at home are planed. The first five are needed to define a realistic and achievable goal of treatment which is accepted by the dyad and the therapist. The following seven interventions will achieve this goal by rehabilitation's intervention (e.g. occupational therapy, psychomotor approach). Four filmed sessions for dyad's assessment are planned (at inclusion, at weeks 5 and 12 after inclusion and 3 months after the last intervention).

Official Title
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Alzheimer Disease : Rehabilitation's Intervention at Home. A Preliminary Pilot Study.

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Behavioral: Home rehabilitation therapy


Participation Criteria
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Eligibility Criteria
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Patient's inclusion criteria: Aged 65 and over AD or mixed dementia (DSM IV TR criteria), documented by a neuropsychological assessment and a brain imaging Living at home Having a caregiver (more than 2 visits per week) Agreement for the study Caregiver's inclusion criteria : More than 2 patient's visits per week Agreement for the study Patient's exclusion criteria: Life expectancy less than 1 year Guardianship Already having a rehabilitation program's therapy Participation in a pharmacological study Caregiver's exclusion criteria: - Medical condition requiring regular care

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home rehabilitation therapy<br>12 weekly sessions of Home rehabilitation therapy | Behavioral: Home rehabilitation therapy<br>* 12 sessions of home rehabilitation therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the mean scores of Instrumental Activities of Daily Living (IADL) | The main objective is to compare the mean scores of Instrumental Activities of Daily Living (IADL) observed at inclusion (day 0) with those observed 27 weeks later (meaning 3 months after the last of the twelfth weekly session of at home rehabilitation therapy). | 27 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the mean scores of Instrumental Activities of Daily Living (IADL) | This objective is to compare the mean scores of Instrumental Activities of Daily Living (IADL) observed at inclusion (day 0) with those observed 5 weeks later (meaning after the fifth weekly session of at home rehabilitation therapy). | 5 weeks | 
| Evaluation of the mean scores of Instrumental Activities of Daily Living (IADL) | This objective is to compare the mean scores of Instrumental Activities of Daily Living (IADL) observed at inclusion (day 0) with those observed 13 weeks later (meaning after the twelfth weekly session of at home rehabilitation therapy). | 13 weeks | 
| Evaluation of the mean scores of Neuro Psychiatric Inventory (NPI) | This objective is to compare the mean scores of Neuro Psychiatric Inventory(NPI) observed at inclusion (day 0) with those observed 27 weeks later (meaning 3 months after the last of the twelfth weekly session of at home rehabilitation therapy). | 27 weeks | 
| Evaluation of the mean scores of Neuro Psychiatric Inventory (NPI) | This objective is to compare the mean scores of Neuro Psychiatric Inventory(NPI) observed at inclusion (day 0) with those observed 5 weeks later (meaning after the last of the fifth weekly session of at home rehabilitation therapy). | 5 weeks | 
| Evaluation of the mean scores of Neuro Psychiatric Inventory (NPI) | This objective is to compare the mean scores of Neuro Psychiatric Inventory(NPI) observed at inclusion (day 0) with those observed 12 weeks later (meaning after the last of the twelfth weekly session of at home rehabilitation therapy). | 13 weeks | 
| Evaluation of the mean scores of Zarit's scale (caregiver burden) | This objective is to compare the mean scores of Zarit's scale observed at inclusion (day 0) with those observed 13 weeks later (meaning after the twelfth weekly session of at home rehabilitation therapy). | 13 weeks | 
| Evaluation of the mean scores of Zarit's scale (caregiver burden) | This objective is to compare the mean scores of Zarit's scale observed at inclusion (day 0) with those observed 27 weeks later (meaning 3 months after the last of the twelfth weekly session of at home rehabilitation therapy). | 27 weeks | 
| Evaluation of the mean scores of Zarit's scale (caregiver burden) | This objective is to compare the mean scores of Zarit's scale observed at inclusion (day 0) with those observed 5 weeks later (meaning after the last of the fifth weekly session of at home rehabilitation therapy). | 5 weeks | 
| Alcohol consumption for the patient and the caregiver | This objective is to compare the alcohol consumption for the patient and the caregiver observed at inclusion (day 0) with those observed 27 weeks later (meaning 3 months after the last of the twelfth weekly session of at home rehabilitation therapy). | 27 weeks | 
| Evaluation of the mean scores of Mini Mental State Examination (MMSE)(meaning evaluation of patient's cognitive impairment) | This objective is to compare the mean scores of Mini Mental State Examination (MMSE) observed at inclusion (day 0) with those observed 27 weeks later (meaning 3 months after the last of the twelfth weekly session of at home rehabilitation therapy). | 27 weeks | 
| Evaluation of the mean scores of Goal Attainment scales (GAS) (meaning evaluation of the satisfaction of the patient and of her/his caregiver) | This objective is to compare the mean scores of Goal Attainment Scales (GAS) observed at inclusion (day 0) with those observed 27 weeks later (meaning 3 months after the last of the twelfth weekly session of at home rehabilitation therapy). | 27 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Home care, rehabilitation therapy, Alzheimer's disease