Alzheimer Disease : Rehabilitation's Intervention at Home (pré MATAPA)
Primary Purpose
Alzheimer's Disease
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Home rehabilitation therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Alzheimer's Disease focused on measuring Home care, rehabilitation therapy, Alzheimer's disease
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
Sites / Locations
- Bellier Hospital, CHU of Nantes
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Home rehabilitation therapy
Arm Description
12 weekly sessions of Home rehabilitation therapy
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
Full Information
NCT ID
NCT01689948
First Posted
September 18, 2012
Last Updated
October 14, 2014
Sponsor
Nantes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01689948
Brief Title
Alzheimer Disease : Rehabilitation's Intervention at Home
Acronym
pré MATAPA
Official Title
Alzheimer Disease : Rehabilitation's Intervention at Home. A Preliminary Pilot Study.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Terminated
Why Stopped
difficulties of recruitment
Study Start Date
October 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Home care, rehabilitation therapy, Alzheimer's disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Home rehabilitation therapy
Arm Type
Experimental
Arm Description
12 weekly sessions of Home rehabilitation therapy
Intervention Type
Behavioral
Intervention Name(s)
Home rehabilitation therapy
Intervention Description
12 sessions of home rehabilitation therapy
Primary Outcome Measure Information:
Title
Evaluation of the mean scores of Instrumental Activities of Daily Living (IADL)
Description
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).
Time Frame
27 weeks
Secondary Outcome Measure Information:
Title
Evaluation of the mean scores of Instrumental Activities of Daily Living (IADL)
Description
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).
Time Frame
5 weeks
Title
Evaluation of the mean scores of Instrumental Activities of Daily Living (IADL)
Description
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).
Time Frame
13 weeks
Title
Evaluation of the mean scores of Neuro Psychiatric Inventory (NPI)
Description
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).
Time Frame
27 weeks
Title
Evaluation of the mean scores of Neuro Psychiatric Inventory (NPI)
Description
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).
Time Frame
5 weeks
Title
Evaluation of the mean scores of Neuro Psychiatric Inventory (NPI)
Description
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).
Time Frame
13 weeks
Title
Evaluation of the mean scores of Zarit's scale (caregiver burden)
Description
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).
Time Frame
13 weeks
Title
Evaluation of the mean scores of Zarit's scale (caregiver burden)
Description
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).
Time Frame
27 weeks
Title
Evaluation of the mean scores of Zarit's scale (caregiver burden)
Description
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).
Time Frame
5 weeks
Title
Alcohol consumption for the patient and the caregiver
Description
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).
Time Frame
27 weeks
Title
Evaluation of the mean scores of Mini Mental State Examination (MMSE)(meaning evaluation of patient's cognitive impairment)
Description
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).
Time Frame
27 weeks
Title
Evaluation of the mean scores of Goal Attainment scales (GAS) (meaning evaluation of the satisfaction of the patient and of her/his caregiver)
Description
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).
Time Frame
27 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilles Berrut, Pr
Organizational Affiliation
Bellier Hospital, CHU of Nantes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bellier Hospital, CHU of Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
12. IPD Sharing Statement
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Alzheimer Disease : Rehabilitation's Intervention at Home
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