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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University Hospital, Toulouse
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01796314
First received: February 19, 2013
Last updated: September 10, 2013
Last verified: September 2013
  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's Disease, Mild to Moderately Severe Stages of AD
Community Dwelling Patients With Family Caregiver
Quality of Life
Behavioral: Therapeutic Educational Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    • 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


Estimated Enrollment: 170
Study Start Date: January 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Groupe 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: Groupe B : Control
There si no associated intervention

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
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: NCT01796314

Contacts
Contact: Hélène VILLARS, MD 05 61 77 64 27 ext 33 villars.h@chu-toulouse.fr
Contact: Audrey ZUERAS 05 61 77 64 27 ext 33 zueras.a@chu-toulouse.fr

Locations
France
CHU de Toulouse, Hôtel-Dieu, 2 rue Viguerie Recruiting
Toulouse, France, 31052
Contact: Audrey ZUERAS    05 61 77 64 27 ext 33    zueras.a@chu-toulouse.fr   
Contact: Fatiha BOUDOUH-PONSARD    05 61 77 72 01 ext 33    boudouh-ponsard.f@chu-toulouse.fr   
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Hélène VILLARS, MD
  More Information

No publications provided

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01796314     History of Changes
Other Study ID Numbers: 11 255 07, PREQHOS n°11 255 07
Study First Received: February 19, 2013
Last Updated: September 10, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Ministry of Health

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
Alzheimer's disease patient's quality of life

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

ClinicalTrials.gov processed this record on August 26, 2014