Impact of Therapeutic Educational Programme on the Alzheimer's Disease Affected Patient's Quality of Life
NCT ID: NCT01796314
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
170 participants
INTERVENTIONAL
2013-01-31
2017-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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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
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.
Group B : Control
There si no associated intervention
No interventions assigned to this group
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
100 Years
ALL
No
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Hélène VILLARS, MD
Role: PRINCIPAL_INVESTIGATOR
Locations
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CHU de Toulouse, Hôtel-Dieu, 2 rue Viguerie
Toulouse, , France
Countries
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References
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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.
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.
Other Identifiers
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PREQHOS n°11 255 07
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
RC31/11/255
Identifier Type: -
Identifier Source: org_study_id