NCT01796314

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P50-P75 for not_applicable alzheimer-disease

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 21, 2013

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

November 1, 2021

Status Verified

October 1, 2021

Enrollment Period

4.1 years

First QC Date

February 19, 2013

Last Update Submit

October 26, 2021

Conditions

Alzheimer Disease

Keywords

Therapeutic educational programme for Alzheimer's disease patients and their caregiverAlzheimer's disease, mild to moderately severe stagesCommunity dwelling patients with family caregiverquality of life

Outcome Measures

Primary Outcomes (1)

  • Alzheimer's Disease patient's quality of life

    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

    2 months

Secondary Outcomes (1)

  • Caregiver quality of life

    2, 6 and 12 months

Study Arms (2)

Group A : intervention

EXPERIMENTAL

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

Group B : Control

NO INTERVENTION

There si no associated intervention

Interventions

Therapeutic Educational ProgramBEHAVIORAL

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.

Also known as: Therapeutic education programme
Group A : intervention

Eligibility Criteria

Age50 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Toulouse, Hôtel-Dieu, 2 rue Viguerie

Toulouse, 31052, France

Location

Related Publications (2)

  • Villars H, Cantet C, de Peretti E, Perrin A, Soto-Martin M, Gardette V. Impact of an educational programme on Alzheimer's disease patients' quality of life: results of the randomized controlled trial THERAD. Alzheimers Res Ther. 2021 Sep 12;13(1):152. doi: 10.1186/s13195-021-00896-3.

    PMID: 34511121RESULT

  • Villars H, Gardette V, Perrin A, Hein C, Elmalem S, de Peretti E, Zueras A, Vellas B, Nourhashemi F. Study protocol: Randomised controlled trial to evaluate the impact of an educational programme on Alzheimer's disease patients' quality of life. Alzheimers Res Ther. 2014 Oct 27;6(5-8):66. doi: 10.1186/s13195-014-0066-1. eCollection 2014.

    PMID: 25478028DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Hélène VILLARS, MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2013

First Posted

February 21, 2013

Study Start

January 1, 2013

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

November 1, 2021

Record last verified: 2021-10

Locations

FR(1)