Alzheimer Disease : Rehabilitation's Intervention at Home

Not Applicable

Terminated

• Conditions: Alzheimer's Disease
• Interventions: Behavioral: Home rehabilitation therapy

• Registration Number: NCT01689948
• Lead Sponsor: Nantes University Hospital

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.

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 Timeline

• Study First Submitted: 2012-09-18
• Study First Submitted QC: 2012-09-20
• Study First Posted: 2012-09-21
• Study Start: 2012-10
• Primary Completion: 2014-05
• Study Completion: 2014-09
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-14
• Last Update Posted: 2014-10-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Home rehabilitation therapy	Home rehabilitation therapy	12 weekly sessions of Home rehabilitation therapy

Primary Outcome Measures

Name	Time	Method
Evaluation of the mean scores of Instrumental Activities of Daily Living (IADL)	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

Name	Time	Method
Evaluation of the mean scores of Instrumental Activities of Daily Living (IADL)	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).
Evaluation of the mean scores of Neuro Psychiatric Inventory (NPI)	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).
Evaluation of the mean scores of Zarit's scale (caregiver burden)	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).
Alcohol consumption for the patient and the caregiver	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).
Evaluation of the mean scores of Mini Mental State Examination (MMSE)(meaning evaluation of patient's cognitive impairment)	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).
Evaluation of the mean scores of Goal Attainment scales (GAS) (meaning evaluation of the satisfaction of the patient and of her/his caregiver)	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).

Trial Locations

Locations (1)

Bellier Hospital, CHU of Nantes; 🇫🇷 Nantes, France