Alzheimer Disease : Rehabilitation's Intervention at Home

NCT ID: NCT01689948

Last Updated: 2014-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-09-30

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).

Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Home rehabilitation therapy

12 weekly sessions of Home rehabilitation therapy

Group Type EXPERIMENTAL

Home rehabilitation therapy

Intervention Type BEHAVIORAL

12 sessions of home rehabilitation therapy

Interventions

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Home rehabilitation therapy

12 sessions of home rehabilitation therapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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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


* More than 2 patient's visits per week
* Agreement for the study

Exclusion Criteria

* Life expectancy less than 1 year
* Guardianship
* Already having a rehabilitation program's therapy
* Participation in a pharmacological study


\- Medical condition requiring regular care
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gilles Berrut, Pr

Role: PRINCIPAL_INVESTIGATOR

Bellier Hospital, CHU of Nantes

Locations

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Bellier Hospital, CHU of Nantes

Nantes, , France

Site Status

Countries

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France

Other Identifiers

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RC12_0080

Identifier Type: -

Identifier Source: org_study_id

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