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Maintenance of Occupational Therapy for Patients With Alzheimer (MaTheoAlz)

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ClinicalTrials.gov Identifier: NCT03435705
Recruitment Status : Recruiting
First Posted : February 16, 2018
Last Update Posted : February 16, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease or Related Disorder Behavioral: maintaining of occupational therapy Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Maintenance of Occupational Therapy for Patients With Alzheimer: A Pragmatic Randomized Trial
Actual Study Start Date : January 17, 2018
Estimated Primary Completion Date : November 17, 2020
Estimated Study Completion Date : November 17, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: intervention arm
maintaining of occupational therapy for a 4 months period
Behavioral: maintaining of occupational therapy
8 home sessions over a 4 months period with caregivers' education, occupational therapy and care coordination for post intervention

No Intervention: control arm
usual care after the end of the recommended initial program



Primary Outcome Measures :
  1. Neuropsychiatric inventory (NPI) score [ Time Frame: NPI score will be measured at 7 months ]
    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.


Secondary Outcome Measures :
  1. Neuropsychiatric inventory (NPI) score [ Time Frame: at inclusion ]
    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.

  2. Neuropsychiatric inventory (NPI) score [ Time Frame: at 3 months ]
    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.

  3. Neuropsychiatric inventory (NPI) score [ Time Frame: at 12 months ]
    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.

  4. The functional autonomy measured by the Disability Assessment in Dementia (DAD scale). [ Time Frame: at inlcusion ]
    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.

  5. The functional autonomy measured by the Disability Assessment in Dementia (DAD scale). [ Time Frame: at 3 months ]
    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.

  6. The functional autonomy measured by the Disability Assessment in Dementia (DAD scale). [ Time Frame: at 7 months ]
    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.

  7. The functional autonomy measured by the Disability Assessment in Dementia (DAD scale). [ Time Frame: at 12 months ]
    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.

  8. Quality of life measured by the Quality of Life in Alzheimer's Disease scale. [ Time Frame: at 3 months ]
    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.

  9. Quality of life measured by the Quality of Life in Alzheimer's Disease scale. [ Time Frame: at 7 months ]
    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.

  10. Quality of life measured by the Quality of Life in Alzheimer's Disease scale. [ Time Frame: at 12 months ]
    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.

  11. Depression of the patient via the Montgomery-Asberg Depression Rating Scale (MADRS). [ Time Frame: at 3 months ]
    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.

  12. Depression of the patient via the Montgomery-Asberg Depression Rating Scale (MADRS). [ Time Frame: at 7 months ]
    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.

  13. Depression of the patient via the Montgomery-Asberg Depression Rating Scale (MADRS). [ Time Frame: at 12 months ]
    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.

  14. Apathy of the patient via the Apathy inventory. [ Time Frame: at 3 months ]
    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)

  15. Apathy of the patient via the Apathy inventory. [ Time Frame: at 7 months ]
    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)

  16. Apathy of the patient via the Apathy inventory. [ Time Frame: at 12 months ]
    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)

  17. Mortality and institutionalization of patients. [ Time Frame: at 3 months ]
    These events as well as their dates will be collected at each follow-up by psychologists with caregivers, or possibly referring physicians.

  18. Mortality and institutionalization of patients. [ Time Frame: at 7 months ]
    These events as well as their dates will be collected at each follow-up by psychologists with caregivers, or possibly referring physicians.

  19. Mortality and institutionalization of patients. [ Time Frame: at 12 months ]
    These events as well as their dates will be collected at each follow-up by psychologists with caregivers, or possibly referring physicians.

  20. The care processes. [ Time Frame: at 3 months ]
    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.

  21. The care processes. [ Time Frame: at 7 months ]
    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.

  22. The care processes. [ Time Frame: at 12 months ]
    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.

  23. The caregiver burden via the Burden Interview with Zarit [ Time Frame: at 3 months ]
    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).

  24. The caregiver burden via the Burden Interview with Zarit [ Time Frame: at 7 months ]
    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).

  25. The caregiver burden via the Burden Interview with Zarit [ Time Frame: at 12 months ]
    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).

  26. The sense of competence of the caregivers [ Time Frame: at 3 months ]
    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.

  27. The sense of competence of the caregivers [ Time Frame: at 7 months ]
    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.

  28. The sense of competence of the caregivers [ Time Frame: at 12 months ]
    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.

  29. Patient care consumption measured by the RUD Lite scale [ Time Frame: at 3 months ]
    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

  30. Patient care consumption measured by the RUD Lite scale [ Time Frame: at 7 months ]
    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

  31. Patient care consumption measured by the RUD Lite scale [ Time Frame: at 12 months ]
    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

  32. The total cost (health and social) of patient care in each of the groups [ Time Frame: at 7 months ]
    The total cost will be described from the data obtained above for the consumption of care and the management processes

  33. The total cost (health and social) of patient care in each of the groups [ Time Frame: at 12 months ]
    The total cost will be described from the data obtained above for the consumption of care and the management processes

  34. The cost per disorder behavior avoided [ Time Frame: at 7 months ]
  35. The cost per disorder behavior avoided [ Time Frame: at 12 months ]
  36. The cost related to the consequences in terms of quality of life of the patient [ Time Frame: at 7 months ]
  37. The cost related to the consequences in terms of quality of life of the patient [ Time Frame: at 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with dementia (regardless of etiology) diagnosed or suspected by their physician (general practitioner or specialist) and referred to an Alzheimer specialized team
  • Patients with Mini Mental State Examination score> 15
  • Patients living at home, in residences for the elderly
  • Presence of a non-professional primary caregiver

Exclusion Criteria:

  • Patients under 18 years of age;
  • Institutionalized or foster care patients;
  • Patients who routinely refuse home care;
  • Patients with a known severe and unstable general pathology that does not allow patient follow-up;
  • Patients already enrolled in another non-drug management trial other than the study;
  • Patients whose institutionalization is probable in the short term (within 6 months) or for whom a change of domicile envisaged in the short term and would not allow the carrying out of the follow-up evaluations;
  • Patients under tutorship or curatorship, patients unable to express consent;
  • Primary caregiver who does not wish to participate in the study or who cannot be available for the follow-up planned for the study;
  • Known cognitive deficits or chronic psychosis that do not able patients' follow-up;
  • Presence of a primary caregiver with known cognitive or psychiatric disorders (chronic active psychosis) , which doesn't allow the proper conduct of the study;
  • Patients who have already benefited from the "occupational" therapy program.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03435705


Contacts
Contact: Jean-François DARTIGUES, M.D., Ph.D 05 57 57 15 02 ext 33 jean-francois.dartigues@u-bordeaux.fr
Contact: Catherine HELMER, M.D., Ph.D 05 57 57 47 15 Catherine.Helmer@u-bordeaux.fr

Locations
France
Aapam-Ssiad Recruiting
Blaignan, France, 33340
Contact: Véronique Prunier    05 56 09 07 89    Sophie.colonge@aapam-medoc.com   
Principal Investigator: Véronique Prunier         
SESAME Recruiting
Bordeaux, France, 33800
Contact: Elodie Yubero    05 56 46 69 65    sesame@aidomi.fr   
Principal Investigator: Elodie Yubero         
Castelsanté Recruiting
Casteljaloux, France, 47700
Contact: Aubin Fajarnes    05 53 89 33 27    afajarnes@castelsante.fr   
Principal Investigator: Aubin Fajarnes         
SSIAD Hauts de garonne Recruiting
Cenon, France, 33150
Contact: Mailys Normand    05 56 40 98 44    Esahautsdegaronne@gmail.com   
Principal Investigator: Mailys Normand         
SSIAD du bassin d'Arcachon Recruiting
La Teste-de-Buch, France, 33260
Contact: Maud Boyer    05 57 52 16 10    secretariat@ssiadarcachon.fr   
Principal Investigator: Maud Boyer         
Vie Santé Merignac Recruiting
Mérignac, France, 33700
Contact: Nadège Hebert    05 56 55 04 38    esprima@orange.fr   
Principal Investigator: Nadège Hebert         
AMSADHG Recruiting
Saint Savin, France, 33920
Contact: Marie-Pierre Guidoux    05 57 58 97 33    v.paillet@amsad33.fr   
Principal Investigator: Marie-pierre Guidoux         
Equipe Espard Recruiting
Talence, France, 33401
Contact: Julia Gaston    05 57 12 40 03    espard@mspb.com   
Principal Investigator: Julia Gaston         
Sponsors and Collaborators
University Hospital, Bordeaux

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03435705     History of Changes
Other Study ID Numbers: CHUBX 2016/29
First Posted: February 16, 2018    Key Record Dates
Last Update Posted: February 16, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders