Alzheimer Disease : Rehabilitation's Intervention at Home (pré MATAPA)

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Alzheimer's Disease	Behavioral: Home rehabilitation therapy	Not Applicable

Detailed Description:

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).

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	17 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Supportive Care
Official Title:	Alzheimer Disease : Rehabilitation's Intervention at Home. A Preliminary Pilot Study.
Study Start Date :	October 2012
Actual Primary Completion Date :	May 2014
Actual Study Completion Date :	September 2014

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Home rehabilitation therapy; 12 weekly sessions of Home rehabilitation therapy	Behavioral: Home rehabilitation therapy; 12 sessions of home rehabilitation therapy

Outcome Measures

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Primary Outcome Measures :

1. Evaluation of the mean scores of Instrumental Activities of Daily Living (IADL) [ Time Frame: 27 weeks ]
   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).

Secondary Outcome Measures :

1. Evaluation of the mean scores of Instrumental Activities of Daily Living (IADL) [ Time Frame: 5 weeks ]
   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).
2. Evaluation of the mean scores of Instrumental Activities of Daily Living (IADL) [ Time Frame: 13 weeks ]
   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).
3. Evaluation of the mean scores of Neuro Psychiatric Inventory (NPI) [ Time Frame: 27 weeks ]
   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).
4. Evaluation of the mean scores of Neuro Psychiatric Inventory (NPI) [ Time Frame: 5 weeks ]
   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. Evaluation of the mean scores of Neuro Psychiatric Inventory (NPI) [ Time Frame: 13 weeks ]
   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).
6. Evaluation of the mean scores of Zarit's scale (caregiver burden) [ Time Frame: 13 weeks ]
   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).
7. Evaluation of the mean scores of Zarit's scale (caregiver burden) [ Time Frame: 27 weeks ]
   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).
8. Evaluation of the mean scores of Zarit's scale (caregiver burden) [ Time Frame: 5 weeks ]
   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).
9. Alcohol consumption for the patient and the caregiver [ Time Frame: 27 weeks ]
   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).
10. Evaluation of the mean scores of Mini Mental State Examination (MMSE)(meaning evaluation of patient's cognitive impairment) [ Time Frame: 27 weeks ]
    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).
11. Evaluation of the mean scores of Goal Attainment scales (GAS) (meaning evaluation of the satisfaction of the patient and of her/his caregiver) [ Time Frame: 27 weeks ]
    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).

Eligibility Criteria

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Ages Eligible for Study:	65 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

France
Bellier Hospital, CHU of Nantes
Nantes, France, 44093

Sponsors and Collaborators

Nantes University Hospital

Investigators

Principal Investigator:	Gilles Berrut, Pr	Bellier Hospital, CHU of Nantes

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Nantes University Hospital
ClinicalTrials.gov Identifier:	NCT01689948 History of Changes
Other Study ID Numbers:	RC12_0080
First Posted:	September 21, 2012
Last Update Posted:	October 15, 2014
Last Verified:	October 2014

Keywords provided by Nantes University Hospital:

Home care, rehabilitation therapy, Alzheimer's disease

Additional relevant MeSH terms:

Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases	Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders