An interventional study of maintaining of occupational therapy in Alzheimer's Disease or Related Disorder, sponsored by University Hospital, Bordeaux. Completed at 8 sites in France. Per ClinicalTrials.gov, last updated 2023-10-13.
Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Supportive care
France put a massive effort for improving dementia care through a national Alzheimer plan in 2008 and this effort was confirmed by the next government (Neurodegenerative Diseases Plan 2014-2019). Some new care models and interventions have been implemented such as Alzheimer specialized teams offering occupational therapy. The teams intervene at home with medical prescription. A recent pilot study demonstrated that occupational therapy has the potential to bring clinical benefits for both dementia patients and their caregivers. Nevertheless, occupational therapy has been designed as a short-term intervention and the end of intervention is challenging for therapists and patients. We aim to test the clinical and economic efficacy of maintaining occupational therapy over supplementary 4 months in a pragmatic randomized controlled trial.
The Alzheimer specialized teams provide "occupational" therapy to maintain or restore the functional capacities of patients. After a deep evaluation of the expectations and needs of patients and their caregivers, the therapists propose to work one or more specific activities that were once pleasant through 12 to 15 sessions at home over 3 months. They also advise individuals to optimize home safety. A pilot observational study that we conducted reported a significant reduction in behavioral disorders of patients during the first 3 months followed by stability. According to the therapists involved in this study, the 3-month format is considered too short to produce perennial benefits; stimulation is often interrupted at the end of the 3 months, which creates a break in management that can be deleterious for patients.
The main objective of this trial is to evaluate the effectiveness of the maintenance of occupational therapy for 4 months beyond the three months provided for in the regulatory framework for the management of demented patients, Measured by the neuropsychiatric inventory (NPI). The secondary objectives will be to study the efficacy on other clinical criteria but also to carry out an economic evaluation of the maintenance of occupational therapy.
Exclusion Criteria:
maintaining of occupational therapy for a 4 months period
Behavioral: maintaining of occupational therapy
usual care after the end of the recommended initial program
8 home sessions over a 4 months period with caregivers' education, occupational therapy and care coordination for post intervention
Neuropsychiatric inventory (NPI) score
Information on the presence, severity and impact of behavioral disorders. NPI is used to evaluate 12 different types of behavior: delusions, apathy, hallucinations, disinhibition, agitation, irritability, depression, aberrant motor behavior, anxiety, night behavior, euphoria, change in appetite and eating behaviors. This inventory is based on the responses obtained by an informed caregiver, preferably living with the patient. The interview is preferably conducted with the caregiver in the patient's absence, to facilitate open discussion of behaviors that may be difficult to describe in the presence of the patient. If a disorder is present, the caregiver should rate the disorder (1: sometimes, 2: quite often, 3: frequently, 4: very frequently) and the severity of the disorder (1: mild, 2: average ; 3: important). An overall score ranging from 0 to 144 is then calculated, a high score representing greater symptoms in presence, frequency and severity.
Time frame: NPI score will be measured at 7 months
Neuropsychiatric inventory (NPI) score
Information on the presence, severity and impact of behavioral disorders. NPI is used to evaluate 12 different types of behavior: delusions, apathy, hallucinations, disinhibition, agitation, irritability, depression, aberrant motor behavior, anxiety, night behavior, euphoria, change in appetite and eating behaviors. This inventory is based on the responses obtained by an informed caregiver, preferably living with the patient. The interview is preferably conducted with the caregiver in the patient's absence, to facilitate open discussion of behaviors that may be difficult to describe in the presence of the patient. If a disorder is present, the caregiver should rate the disorder (1: sometimes, 2: quite often, 3: frequently, 4: very frequently) and the severity of the disorder (1: mild, 2: average ; 3: important). An overall score ranging from 0 to 144 is then calculated, a high score representing greater symptoms in presence, frequency and severity.
Time frame: at inclusion
Neuropsychiatric inventory (NPI) score
Information on the presence, severity and impact of behavioral disorders. NPI is used to evaluate 12 different types of behavior: delusions, apathy, hallucinations, disinhibition, agitation, irritability, depression, aberrant motor behavior, anxiety, night behavior, euphoria, change in appetite and eating behaviors. This inventory is based on the responses obtained by an informed caregiver, preferably living with the patient. The interview is preferably conducted with the caregiver in the patient's absence, to facilitate open discussion of behaviors that may be difficult to describe in the presence of the patient. If a disorder is present, the caregiver should rate the disorder (1: sometimes, 2: quite often, 3: frequently, 4: very frequently) and the severity of the disorder (1: mild, 2: average ; 3: important). An overall score ranging from 0 to 144 is then calculated, a high score representing greater symptoms in presence, frequency and severity.
Time frame: at 3 months
Neuropsychiatric inventory (NPI) score
Information on the presence, severity and impact of behavioral disorders. NPI is used to evaluate 12 different types of behavior: delusions, apathy, hallucinations, disinhibition, agitation, irritability, depression, aberrant motor behavior, anxiety, night behavior, euphoria, change in appetite and eating behaviors. This inventory is based on the responses obtained by an informed caregiver, preferably living with the patient. The interview is preferably conducted with the caregiver in the patient's absence, to facilitate open discussion of behaviors that may be difficult to describe in the presence of the patient. If a disorder is present, the caregiver should rate the disorder (1: sometimes, 2: quite often, 3: frequently, 4: very frequently) and the severity of the disorder (1: mild, 2: average ; 3: important). An overall score ranging from 0 to 144 is then calculated, a high score representing greater symptoms in presence, frequency and severity.
Time frame: at 12 months
The functional autonomy measured by the Disability Assessment in Dementia (DAD scale).
This scale concerns the activities of the patient in his daily life (dressing, toilet, medication management in particular). It evaluates 5 basic activities and 5 instrumental activities. Each of the 10 activities is broken down into 3 factors entitled: "initiation" ("the patient takes only the initiative of"), "organization" ("he or she plans, organizes the activity"), "effective action" (" the activity is carried out efficiently "). The DAD is completed during an interview with the caregiver. An overall score ranges from 0 to 40, this score is converted to a percentage.
Time frame: at inlcusion
The functional autonomy measured by the Disability Assessment in Dementia (DAD scale).
This scale concerns the activities of the patient in his daily life (dressing, toilet, medication management in particular). It evaluates 5 basic activities and 5 instrumental activities. Each of the 10 activities is broken down into 3 factors entitled: "initiation" ("the patient takes only the initiative of"), "organization" ("he or she plans, organizes the activity"), "effective action" (" the activity is carried out efficiently "). The DAD is completed during an interview with the caregiver. An overall score ranges from 0 to 40, this score is converted to a percentage.
Time frame: at 3 months
The functional autonomy measured by the Disability Assessment in Dementia (DAD scale).
This scale concerns the activities of the patient in his daily life (dressing, toilet, medication management in particular). It evaluates 5 basic activities and 5 instrumental activities. Each of the 10 activities is broken down into 3 factors entitled: "initiation" ("the patient takes only the initiative of"), "organization" ("he or she plans, organizes the activity"), "effective action" (" the activity is carried out efficiently "). The DAD is completed during an interview with the caregiver. An overall score ranges from 0 to 40, this score is converted to a percentage.
Time frame: at 7 months
The functional autonomy measured by the Disability Assessment in Dementia (DAD scale).
This scale concerns the activities of the patient in his daily life (dressing, toilet, medication management in particular). It evaluates 5 basic activities and 5 instrumental activities. Each of the 10 activities is broken down into 3 factors entitled: "initiation" ("the patient takes only the initiative of"), "organization" ("he or she plans, organizes the activity"), "effective action" (" the activity is carried out efficiently "). The DAD is completed during an interview with the caregiver. An overall score ranges from 0 to 40, this score is converted to a percentage.
Time frame: at 12 months
Quality of life measured by the Quality of Life in Alzheimer's Disease scale.
This 13-item scale explores 6 areas of subjective health: fitness, mood, memory, the patient's relationship with family members, financial hardship, and general health. This tool generates quality of life scores per patient ranging from 13 to 52. This score can be weighted by the answers provided by the caregiver. For this weighting, we multiply the patient score by 2, add the caregiver score and divide by 3 to bring the score back to that of the initial scale.
Time frame: at 3 months
Quality of life measured by the Quality of Life in Alzheimer's Disease scale.
This 13-item scale explores 6 areas of subjective health: fitness, mood, memory, the patient's relationship with family members, financial hardship, and general health. This tool generates quality of life scores per patient ranging from 13 to 52. This score can be weighted by the answers provided by the caregiver. For this weighting, we multiply the patient score by 2, add the caregiver score and divide by 3 to bring the score back to that of the initial scale.
Time frame: at 7 months
Quality of life measured by the Quality of Life in Alzheimer's Disease scale.
This 13-item scale explores 6 areas of subjective health: fitness, mood, memory, the patient's relationship with family members, financial hardship, and general health. This tool generates quality of life scores per patient ranging from 13 to 52. This score can be weighted by the answers provided by the caregiver. For this weighting, we multiply the patient score by 2, add the caregiver score and divide by 3 to bring the score back to that of the initial scale.
Time frame: at 12 months
Depression of the patient via the Montgomery-Asberg Depression Rating Scale (MADRS).
This hetero-evaluation scale is used to assess the depressive symptomatology by exploring 10 components: apparent sadness, expressed sadness, internal tension, sleep reduction, appetite reduction, concentration, lassitude, inability to feel, pessimistic thoughts, suicide ideas. Each component is rated from 0 to 6. The total score ranges from 0 to 60, a high score characterizing a depressive symptomatology.
Time frame: at 3 months
Depression of the patient via the Montgomery-Asberg Depression Rating Scale (MADRS).
This hetero-evaluation scale is used to assess the depressive symptomatology by exploring 10 components: apparent sadness, expressed sadness, internal tension, sleep reduction, appetite reduction, concentration, lassitude, inability to feel, pessimistic thoughts, suicide ideas. Each component is rated from 0 to 6. The total score ranges from 0 to 60, a high score characterizing a depressive symptomatology.
Time frame: at 7 months
Depression of the patient via the Montgomery-Asberg Depression Rating Scale (MADRS).
This hetero-evaluation scale is used to assess the depressive symptomatology by exploring 10 components: apparent sadness, expressed sadness, internal tension, sleep reduction, appetite reduction, concentration, lassitude, inability to feel, pessimistic thoughts, suicide ideas. Each component is rated from 0 to 6. The total score ranges from 0 to 60, a high score characterizing a depressive symptomatology.
Time frame: at 12 months
Apathy of the patient via the Apathy inventory.
This questionnaire that collects information on the presence of apathy in patients suffering from cerebral pathologies. It allows the assessment of three clinical dimensions of apathy: emotional blurring, loss of initiative and loss of interest. The assessment is based on the answers of the accompanying person, and because of this, it can also be carried out in severe deteriorations. The possibility of obtaining the patient's appreciation also makes it possible to evaluate the patient's awareness of his disorders. The evaluation of these 3 dimensions takes into account the frequency (rated from 1 to 4) and the severity of the symptoms (rated from 1 to 3). The score for each dimension is obtained by multiplying these two scores, so that the score for each dimension varies from 0 (absence of the symptom) to 12 (very frequent symptom and of serious gravity)
Time frame: at 3 months
Apathy of the patient via the Apathy inventory.
This questionnaire that collects information on the presence of apathy in patients suffering from cerebral pathologies. It allows the assessment of three clinical dimensions of apathy: emotional blurring, loss of initiative and loss of interest. The assessment is based on the answers of the accompanying person, and because of this, it can also be carried out in severe deteriorations. The possibility of obtaining the patient's appreciation also makes it possible to evaluate the patient's awareness of his disorders. The evaluation of these 3 dimensions takes into account the frequency (rated from 1 to 4) and the severity of the symptoms (rated from 1 to 3). The score for each dimension is obtained by multiplying these two scores, so that the score for each dimension varies from 0 (absence of the symptom) to 12 (very frequent symptom and of serious gravity)
Time frame: at 7 months
Apathy of the patient via the Apathy inventory.
This questionnaire that collects information on the presence of apathy in patients suffering from cerebral pathologies. It allows the assessment of three clinical dimensions of apathy: emotional blurring, loss of initiative and loss of interest. The assessment is based on the answers of the accompanying person, and because of this, it can also be carried out in severe deteriorations. The possibility of obtaining the patient's appreciation also makes it possible to evaluate the patient's awareness of his disorders. The evaluation of these 3 dimensions takes into account the frequency (rated from 1 to 4) and the severity of the symptoms (rated from 1 to 3). The score for each dimension is obtained by multiplying these two scores, so that the score for each dimension varies from 0 (absence of the symptom) to 12 (very frequent symptom and of serious gravity)
Time frame: at 12 months
Mortality and institutionalization of patients.
These events as well as their dates will be collected at each follow-up by psychologists with caregivers, or possibly referring physicians.
Time frame: at 3 months
Mortality and institutionalization of patients.
These events as well as their dates will be collected at each follow-up by psychologists with caregivers, or possibly referring physicians.
Time frame: at 7 months
Mortality and institutionalization of patients.
These events as well as their dates will be collected at each follow-up by psychologists with caregivers, or possibly referring physicians.
Time frame: at 12 months
The care processes.
Treatment (anti-dementia, anti-depressant, antipsychotic), consultation with a medical specialist in the last 3 months, speech therapy, home help and type, perception of Personalized Independence Allowance (APA) and the use of a day care will be collected at each follow-up to determine if maintaining the therapy can influence one or more medical and / or social management processes.
Time frame: at 3 months
The care processes.
Treatment (anti-dementia, anti-depressant, antipsychotic), consultation with a medical specialist in the last 3 months, speech therapy, home help and type, perception of Personalized Independence Allowance (APA) and the use of a day care will be collected at each follow-up to determine if maintaining the therapy can influence one or more medical and / or social management processes.
Time frame: at 7 months
The care processes.
Treatment (anti-dementia, anti-depressant, antipsychotic), consultation with a medical specialist in the last 3 months, speech therapy, home help and type, perception of Personalized Independence Allowance (APA) and the use of a day care will be collected at each follow-up to determine if maintaining the therapy can influence one or more medical and / or social management processes.
Time frame: at 12 months
The caregiver burden via the Burden Interview with Zarit
This questionnaire is composed of 22 items measuring the burden of the caregiver. The score on this questionnaire varies from 0 to 88, a high score characterizing a severe "burden". The questionnaire can also be interpreted qualitatively according to 4 modalities (light, light to moderate, moderate to severe and severe).
Time frame: at 3 months
The caregiver burden via the Burden Interview with Zarit
This questionnaire is composed of 22 items measuring the burden of the caregiver. The score on this questionnaire varies from 0 to 88, a high score characterizing a severe "burden". The questionnaire can also be interpreted qualitatively according to 4 modalities (light, light to moderate, moderate to severe and severe).
Time frame: at 7 months
The caregiver burden via the Burden Interview with Zarit
This questionnaire is composed of 22 items measuring the burden of the caregiver. The score on this questionnaire varies from 0 to 88, a high score characterizing a severe "burden". The questionnaire can also be interpreted qualitatively according to 4 modalities (light, light to moderate, moderate to severe and severe).
Time frame: at 12 months
The sense of competence of the caregivers
This composite questionnaire is constructed based on items from the Zarit scale, and from the Bengtson and Kuypers questionnaire \[66\]. This 35-item questionnaire covers 3 areas: the consequences of caring involvement in the caregiver's personal life, satisfaction with his or her own performance as a caregiver, and patient satisfaction as a recipient of the caregiver's care.
Time frame: at 3 months
The sense of competence of the caregivers
This composite questionnaire is constructed based on items from the Zarit scale, and from the Bengtson and Kuypers questionnaire \[66\]. This 35-item questionnaire covers 3 areas: the consequences of caring involvement in the caregiver's personal life, satisfaction with his or her own performance as a caregiver, and patient satisfaction as a recipient of the caregiver's care.
Time frame: at 7 months
The sense of competence of the caregivers
This composite questionnaire is constructed based on items from the Zarit scale, and from the Bengtson and Kuypers questionnaire \[66\]. This 35-item questionnaire covers 3 areas: the consequences of caring involvement in the caregiver's personal life, satisfaction with his or her own performance as a caregiver, and patient satisfaction as a recipient of the caregiver's care.
Time frame: at 12 months
Patient care consumption measured by the RUD Lite scale
Questionnaire estimating medical and medico-social costs related to patient care. This estimate is based on the assessment of the amount of formal resources (drug treatment, hospitalization, outpatient, day hospital, social services, home care) and informal (care and support provided by the caregiver) implied by the daily care of the patient; the resources are valued economically by using the rates of the health insurance and the hourly costs of the medico-social help at home
Time frame: at 3 months
Patient care consumption measured by the RUD Lite scale
Questionnaire estimating medical and medico-social costs related to patient care. This estimate is based on the assessment of the amount of formal resources (drug treatment, hospitalization, outpatient, day hospital, social services, home care) and informal (care and support provided by the caregiver) implied by the daily care of the patient; the resources are valued economically by using the rates of the health insurance and the hourly costs of the medico-social help at home
Time frame: at 7 months
Patient care consumption measured by the RUD Lite scale
Questionnaire estimating medical and medico-social costs related to patient care. This estimate is based on the assessment of the amount of formal resources (drug treatment, hospitalization, outpatient, day hospital, social services, home care) and informal (care and support provided by the caregiver) implied by the daily care of the patient; the resources are valued economically by using the rates of the health insurance and the hourly costs of the medico-social help at home
Time frame: at 12 months
The total cost (health and social) of patient care in each of the groups
The total cost will be described from the data obtained above for the consumption of care and the management processes
Time frame: at 7 months
The total cost (health and social) of patient care in each of the groups
The total cost will be described from the data obtained above for the consumption of care and the management processes
Time frame: at 12 months
The cost per disorder behavior avoided
Time frame: at 7 months
The cost per disorder behavior avoided
Time frame: at 12 months
The cost related to the consequences in terms of quality of life of the patient
Time frame: at 7 months
The cost related to the consequences in terms of quality of life of the patient
Time frame: at 12 months
Plan to share: No
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University Hospital, Bordeaux