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

Alzheimer Disease Clinical Trial

— THERAD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01796314
• Other study ID #: RC31/11/255
• Secondary ID: PREQHOS n°11 255
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: February 2017

Study information

• Verified date: October 2021
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study is designed to determine whether a therapeutic educational programme for both AD patients, in community dwelling, and their primary caregivers improves patient's quality of life, after two months.

Design : This study is a monocentric randomised controlled intervention trial

Population : One hundred and seventy dyads 'patient-caregiver' in which the patient suffers from mild to moderately severe Alzheimer's disease patients (MMSE 11 to 26), lives in community dwelling and has a primary caregiver will be included during eighteen months. The primary caregiver is define as a person living with the patient or providing care at least 3 times a week or 8 hours per week; he/she isn't a professional. Eighty five dyad will be include in the intervention group (group A) and eighty five in the control group (group B).

Outcome : Our primary endpoint is the AD patient's quality of life assessed by Logsdon's Quality of life in Alzheimer's Disease scale (Qol-AD) reported by the caregiver at two months.

Our secondary endpoints are 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, and caregiver's quality of life assessed by the Nottingham Health Profile at 6 months. The patient quality of life will also be recorded at 12 months on the logsdon's Quality of Life in Alzheimer's Disease scale reported, and at every visit (MO, M2, M6, et M12) on the same scale dut (QoL-AD) reported by the patient himself.

Intervention :

The intervention is a therapeutic educational programme. 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.

The intervention group (n=85) will benefit from an educational programme that includes two consultations for the dyad AD patient/caregiver and four group sessions for caregivers only. The two consultations will be held at baseline (MO) and two months later (M2); the first one (MO)will include : the 'educational diagnosis', the comprehensive assessment of the patient and assessment of the judgement criteria. Between MO and M2 the primary caregivers will participate to four collective sessions one per week about, of 3 hours length : 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. At M2, the dyad will benefit from : assessment of response to the educational objectives and of the judgement criteria.

The control group (n=85) will benefit from routine care.

The intervention will be implemented over an eighteen month period.

Monitoring will consist of a two consultations to 6 and 12 months including assessment of primary and secondary judgment criteria.

Data collection :

Data will be collected in Access data basis and SAS software will be used to perform statistic analysis. Intention to treat analysis using linear mixed model will be performed, adjusting for patient (disease severity), caregiver characteristics (burden) and occurence of life event that may interfere with the patient's quality of life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

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 : Knowledge of the disease Pharmacological and non pharmacological treatments. Behavioural and psychological symptoms of dementia Crisis situations. Prevention of caregiver's exhaustion Assistive devices and care pathways. Monitoring will consist of a two consultations to 6 and 12 months including assessment of secondary outcome measures.

Locations

Country	Name	City	State
France	CHU de Toulouse, Hôtel-Dieu, 2 rue Viguerie	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Caregiver quality of life	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	2, 6 and 12 months