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Alzheimer Disease : Rehabilitation's Intervention at Home (pré MATAPA)

This study has been terminated.
(difficulties of recruitment)
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01689948
First received: September 18, 2012
Last updated: October 14, 2014
Last verified: October 2014
History of Changes
  Purpose

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.


Condition Intervention
Alzheimer's Disease
 Behavioral: Home rehabilitation therapy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Alzheimer Disease : Rehabilitation's Intervention at Home. A Preliminary Pilot Study.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Evaluation of the mean scores of Instrumental Activities of Daily Living (IADL) [ Time Frame: 27 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 27 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 27 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 27 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 27 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 27 weeks ] [ Designated as safety issue: No ]
    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).
Enrollment: 17
Study Start Date: October 2012
Study Completion Date: September 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Home rehabilitation therapy
12 weekly sessions of Home rehabilitation therapy
 Behavioral: Home rehabilitation therapy
12 sessions of home rehabilitation therapy

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
Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01689948

Locations
France
Bellier Hospital, CHU of Nantes
Nantes, France, 44093
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Gilles Berrut, Pr Bellier Hospital, CHU of Nantes
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01689948     History of Changes
Other Study ID Numbers: RC12_0080
Study First Received: September 18, 2012
Last Updated: October 14, 2014
Health Authority: France: French Health authority

Keywords provided by Nantes University Hospital:
Home care, rehabilitation therapy, Alzheimer's disease

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
 Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on March 03, 2015