Clinical trial NCT01689948: Alzheimer Disease : Rehabilitation's Intervention at Home
Official title: Alzheimer Disease : Rehabilitation's Intervention at Home. A Preliminary Pilot Study.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Alzheimer's Disease
Keywords: Home care, rehabilitation therapy, Alzheimer's disease
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2012-09-21
Enrollment: 17
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility 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

Primary outcomes:
measure: Evaluation of the mean scores of Instrumental Activities of Daily Living (IADL)
timeFrame: 27 weeks
Secondary outcomes:
measure: Evaluation of the mean scores of Instrumental Activities of Daily Living (IADL)
timeFrame: 5 weeks
measure: Evaluation of the mean scores of Instrumental Activities of Daily Living (IADL)
timeFrame: 13 weeks
measure: Evaluation of the mean scores of Neuro Psychiatric Inventory (NPI)
timeFrame: 27 weeks
measure: Evaluation of the mean scores of Neuro Psychiatric Inventory (NPI)
timeFrame: 5 weeks
measure: Evaluation of the mean scores of Neuro Psychiatric Inventory (NPI)
timeFrame: 13 weeks
measure: Evaluation of the mean scores of Zarit's scale (caregiver burden)
timeFrame: 13 weeks
measure: Evaluation of the mean scores of Zarit's scale (caregiver burden)
timeFrame: 27 weeks
measure: Evaluation of the mean scores of Zarit's scale (caregiver burden)
timeFrame: 5 weeks
measure: Alcohol consumption for the patient and the caregiver
timeFrame: 27 weeks
measure: Evaluation of the mean scores of Mini Mental State Examination (MMSE)(meaning evaluation of patient's cognitive impairment)
timeFrame: 27 weeks
measure: Evaluation of the mean scores of Goal Attainment scales (GAS) (meaning evaluation of the satisfaction of the patient and of her/his caregiver)
timeFrame: 27 weeks
Other outcomes:
Locations:
city: Nantes
country: France
facility: Bellier Hospital, CHU of Nantes
Study officials:
affiliation: Bellier Hospital, CHU of Nantes
name: Gilles Berrut, Pr
role: PRINCIPAL_INVESTIGATOR
References: