Alzheimer Disease : Rehabilitation's Intervention at Home

Alzheimer's Disease Clinical Trial

— pré MATAPA  

Official title:

Alzheimer Disease : Rehabilitation's Intervention at Home. A Preliminary Pilot Study.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01689948
• Other study ID #: RC12_0080
• Status: Terminated
• Phase: N/A
• First received: September 18, 2012
• Last updated: October 14, 2014
• Start date: October 2012
• Est. completion date: September 2014

Study information

• Verified date: October 2014
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: French Health authority
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: September 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Behavioral:
• Home rehabilitation therapy
12 sessions of home rehabilitation therapy

Locations

Country	Name	City	State
France	Bellier Hospital, CHU of Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	27 weeks	No
Secondary	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).	5 weeks	No
Secondary	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).	13 weeks	No
Secondary	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).	27 weeks	No
Secondary	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).	5 weeks	No
Secondary	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).	13 weeks	No
Secondary	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).	13 weeks	No
Secondary	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).	27 weeks	No
Secondary	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).	5 weeks	No
Secondary	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).	27 weeks	No
Secondary	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).	27 weeks	No
Secondary	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).	27 weeks	No