Impact of Therapeutic Educational Programme on the Alzheimer's Disease Affected Patient's Quality of Life
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Therapeutic Educational Program
Intervention type(s): Behavioral
Intervention description(s): 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.
Other intervention name(s): Therapeutic education programme
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: 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