Alzheimer Disease : Rehabilitation's Intervention at Home

NCT01689948 | Terminated

• 1 other identifier: RC12_0080
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease

Keywords

Home care, rehabilitation therapy, Alzheimer's disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (11)

• Evaluation of the mean scores of Instrumental Activities of Daily Living (IADL)

  5 weeks

• Evaluation of the mean scores of Instrumental Activities of Daily Living (IADL)

  13 weeks

• Evaluation of the mean scores of Neuro Psychiatric Inventory (NPI)

  27 weeks

• Evaluation of the mean scores of Neuro Psychiatric Inventory (NPI)

  5 weeks

• Evaluation of the mean scores of Neuro Psychiatric Inventory (NPI)

  13 weeks

Study Arms (1)

Home rehabilitation therapy

EXPERIMENTAL

12 weekly sessions of Home rehabilitation therapy

Behavioral: Home rehabilitation therapy

Interventions

Home rehabilitation therapy BEHAVIORAL

12 sessions of home rehabilitation therapy

Home rehabilitation therapy

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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
• More than 2 patient's visits per week
• Agreement for the study

You may not qualify if:

• Life expectancy less than 1 year
• Guardianship
• Already having a rehabilitation program's therapy
• Participation in a pharmacological study
• \- Medical condition requiring regular care

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Bellier Hospital, CHU of Nantes

Nantes, 44093, France

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Gilles Berrut, Pr

  Bellier Hospital, CHU of Nantes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2012
• First Posted: September 21, 2012
• Study Start: October 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 15, 2014

Record last verified: 2014-10

Locations

FR (1)