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Impact of Therapeutic Educational Programme on the Alzheimer's Disease Affected Patient's Quality of Life (THERAD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01796314
First Posted: February 21, 2013
Last Update Posted: November 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Toulouse
  Purpose
Therapeutic education expands in Alzheimer's Disease management in France. Several studies revealed a positive impact on caregiver's burden and/or quality of life. The purpose of this study, is to determine whether a therapeutic educational programme for both AD patients and primary caregivers, in community dwelling, improves patient's quality of life.

Condition Intervention
Alzheimer Disease Behavioral: Therapeutic Educational Program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Impact of a Therapeutic Educational Programme for Alzheimer's Disease Patients and Their Caregiver in Community Dwelling, on the AD Patient's Quality of Life

Resource links provided by NLM:


Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • Quality of life [ Time Frame: 2 months ]
    Alzheimer's Disease patient's quality of life assessed by Logsdon's Quality of life in Alzheimer's Disease scale (QoL-AD) reported by the caregiver


Secondary Outcome Measures:
  • Caregiver quality of life [ Time Frame: 2, 6 and 12 months ]
    • Caregiver's burden assessed by the Zarit Burden Inventory
    • Frequency and severity of behavioural and psychological symptoms assessed by the Neuro Psychiatric inventory
    • Independence in personal and instrumental daily life activities assessed by Katz's Activities of Daily Living and Lawton's Instrumental Activities of Daily Living scales
    • Caregiver's quality of life assessed by the Nottingham Health Profile at 6 months
    • Patient quality of life at 6 and 12 months on the Logsdon's Quality of Life in Alzheimer's Disease scale reported by the caregiver
    • Patient quality of life at 2,6 and 12 months on the Logsdon's Quality of Life in Alzheimer's Disease scale reported by the patient himself


Enrollment: 170
Study Start Date: January 2013
Study Completion Date: February 2017
Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A : intervention
85 dyads "patient/caregiver" in witch the patient suffers from mild to moderately severe Alzheimer's disease patients (MMSE 11 to 26), and lives at home with a caregiver
Behavioral: Therapeutic Educational Program

The intervention is a therapeutic educational programme as recommended in the care of Alzheimer's disease. It includes two consultations for the dyad AD patient/caregiver and four group sessions, one a week, for caregivers only. The intervention length is 2 months.

These collective sessions focus on :

  1. Knowledge of the disease
  2. Pharmacological and non pharmacological treatments. Behavioural and psychological symptoms of dementia
  3. Crisis situations. Prevention of caregiver's exhaustion
  4. Assistive devices and care pathways.

Monitoring will consist of a two consultations to 6 and 12 months including assessment of secondary outcome measures.

Other Name: Therapeutic education programme
No Intervention: Group B : Control
There si no associated intervention

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patient suffering from mild to moderately severe Alzheimer's disease patients (MMSE 11 to 26)
  • in community dwelling
  • with an informal caregiver (person living with the patient or providing care 3 times a week or 8 hours per week)
  • is informed and has given his/her consent
  • whom caregiver is informed and has given his/her consent

Exclusion Criteria:

  • patient with other type of dementia
  • living in nursing home or long term care
  • with no caregiver
  • not informed or has not given his/her consent
  • whom caregiver is not informed or has not given his/her consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01796314


Locations
France
CHU de Toulouse, Hôtel-Dieu, 2 rue Viguerie
Toulouse, France, 31052
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Hélène VILLARS, MD
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01796314     History of Changes
Other Study ID Numbers: 11 255 07
PREQHOS n°11 255 07 ( Other Grant/Funding Number: Ministry of Health )
First Submitted: February 19, 2013
First Posted: February 21, 2013
Last Update Posted: November 1, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Toulouse:
Therapeutic educational programme for Alzheimer's disease patients and their caregiver
Alzheimer's disease, mild to moderately severe stages
Community dwelling patients with family caregiver
quality of life

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders