Alzheimer's Disease or Related DisorderMaTheoAlzNCT03435705
Maintenance of Occupational Therapy for Patients With Alzheimer
A study testing maintaining of occupational therapy in people with Alzheimer's Disease or Related Disorder, run by University Hospital, Bordeaux at 8 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer's Disease or Related Disorder
- What is being tested?
- maintaining of occupational therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 8 sitesFrance
- Study dates
- 17 Jan 2018to 4 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Show all 11Show fewer
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Aapam-Ssiad
Blaignan, 33340
SESAME
Bordeaux, 33800
Castelsanté
Casteljaloux, 47700
SSIAD Hauts de garonne
Cenon, 33150
SSIAD du bassin d'Arcachon
La Teste-de-Buch, 33260
Vie Santé Merignac
Mérignac, 33700
AMSADHG
Saint-Savin, 33920
Equipe Espard
Talence, 33401
About this study
Official title: Maintenance of Occupational Therapy for Patients With Alzheimer: A Pragmatic Randomized Trial
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.
Read the 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.
- Conditions
- Alzheimer's Disease or Related Disorder
- Being tested
- maintaining of occupational therapy
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maintaining of occupational therapyBehavioural
8 home sessions over a 4 months period with caregivers' education, occupational therapy and care coordination for post intervention
| Study group | Role | What they receive |
|---|---|---|
| intervention arm | Experimental | maintaining of occupational therapy for a 4 months period Receives: Behavioral: maintaining of occupational therapy |
| control arm | No intervention | usual care after the end of the recommended initial program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: NPI score will be measured at 7 months
Secondary outcomes (37)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: at 12 months
The cost per disorder behavior avoided
Measured: at 7 months
The cost per disorder behavior avoided
Measured: at 12 months
The cost related to the consequences in terms of quality of life of the patient
Measured: at 7 months
The cost related to the consequences in terms of quality of life of the patient
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start17 Jan 2018
- Primary completion4 Nov 2019
- Study completion4 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's Disease or Related DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03435705
- Sponsor's protocol ID
- CHUBX 2016/29
- Acronym
- MaTheoAlz
- Status last verified
- Oct 2023
- First submitted
- 18 Jan 2018
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pimouguet C, Le Goff M, Wittwer J, Dartigues JF, Helmer C. Benefits of Occupational Therapy in Dementia Patients: Findings from a Real-World Observational Study. J Alzheimers Dis. 2017;56(2):509-517. doi: 10.3233/JAD-160820.
PubMed 27983551Pimouguet C, Kret M, Francis-Oliviero F, Le Goff M, Wittwer J, Dartigues JF, Helmer C. Maintenance of occupational therapy for individuals with dementia: Findings from a pragmatic randomized controlled trial. J Alzheimers Dis. 2026 Jun;111(3):1362-1372. doi: 10.1177/13872877261442233. Epub 2026 Apr 17.
PubMed 41995479Pimouguet C, Sitta R, Wittwer J, Hayes N, Petit-Moneger A, Dartigues JF, Helmer C. Maintenance of occupational therapy (OT) for dementia: protocol of a multi-center, randomized controlled and pragmatic trial. BMC Geriatr. 2019 Feb 6;19(1):35. doi: 10.1186/s12877-019-1046-x.
PubMed 30727947
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance of Occupational Therapy for Patients With Alzheimer: A Pragmatic Randomized Trial
- ClinicalTrials.gov ID
- NCT03435705
- Acronym / sponsor ID
- MaTheoAlz / CHUBX 2016/29
- Conditions
- Alzheimer's Disease or Related Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 17 Jan 2018 (actual)
- Primary completion
- 4 Nov 2019 (actual)
- Study completion
- 4 Nov 2019 (actual)
- First posted
- 19 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention arm | Experimental | Behavioral: maintaining of occupational therapymaintaining of occupational therapy for a 4 months period |
| control arm | No intervention | –usual care after the end of the recommended initial program |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| maintaining of occupational therapy8 home sessions over a 4 months period with caregivers' education, occupational therapy and care coordination for post intervention | Behavioural | intervention arm |
Primary outcome
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.
37 secondary outcomes
Neuropsychiatric inventory (NPI) score
Time frame: at inclusion
Neuropsychiatric inventory (NPI) score
Time frame: at 3 months
Neuropsychiatric inventory (NPI) score
Time frame: at 12 months
The functional autonomy measured by the Disability Assessment in Dementia (DAD scale).
Time frame: at inlcusion
The functional autonomy measured by the Disability Assessment in Dementia (DAD scale).
Time frame: at 3 months
The functional autonomy measured by the Disability Assessment in Dementia (DAD scale).
Time frame: at 7 months
The functional autonomy measured by the Disability Assessment in Dementia (DAD scale).
Time frame: at 12 months
Quality of life measured by the Quality of Life in Alzheimer's Disease scale.
Time frame: at 3 months
Quality of life measured by the Quality of Life in Alzheimer's Disease scale.
Time frame: at 7 months
Quality of life measured by the Quality of Life in Alzheimer's Disease scale.
Time frame: at 12 months
Depression of the patient via the Montgomery-Asberg Depression Rating Scale (MADRS).
Time frame: at 3 months
Depression of the patient via the Montgomery-Asberg Depression Rating Scale (MADRS).
Time frame: at 7 months
Depression of the patient via the Montgomery-Asberg Depression Rating Scale (MADRS).
Time frame: at 12 months
Apathy of the patient via the Apathy inventory.
Time frame: at 3 months
Apathy of the patient via the Apathy inventory.
Time frame: at 7 months
Apathy of the patient via the Apathy inventory.
Time frame: at 12 months
Mortality and institutionalization of patients.
Time frame: at 3 months
Mortality and institutionalization of patients.
Time frame: at 7 months
Mortality and institutionalization of patients.
Time frame: at 12 months
The care processes.
Time frame: at 3 months
The care processes.
Time frame: at 7 months
The care processes.
Time frame: at 12 months
The caregiver burden via the Burden Interview with Zarit
Time frame: at 3 months
The caregiver burden via the Burden Interview with Zarit
Time frame: at 7 months
The caregiver burden via the Burden Interview with Zarit
Time frame: at 12 months
The sense of competence of the caregivers
Time frame: at 3 months
The sense of competence of the caregivers
Time frame: at 7 months
The sense of competence of the caregivers
Time frame: at 12 months
Patient care consumption measured by the RUD Lite scale
Time frame: at 3 months
Patient care consumption measured by the RUD Lite scale
Time frame: at 7 months
Patient care consumption measured by the RUD Lite scale
Time frame: at 12 months
The total cost (health and social) of patient care in each of the groups
Time frame: at 7 months
The total cost (health and social) of patient care in each of the groups
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- Background: PubMed 27983551Pimouguet C, Le Goff M, Wittwer J, Dartigues JF, Helmer C. Benefits of Occupational Therapy in Dementia Patients: Findings from a Real-World Observational Study. J Alzheimers Dis. 2017;56(2):509-517. doi: 10.3233/JAD-160820.
- Derived from this study: PubMed 41995479Pimouguet C, Kret M, Francis-Oliviero F, Le Goff M, Wittwer J, Dartigues JF, Helmer C. Maintenance of occupational therapy for individuals with dementia: Findings from a pragmatic randomized controlled trial. J Alzheimers Dis. 2026 Jun;111(3):1362-1372. doi: 10.1177/13872877261442233. Epub 2026 Apr 17.
- Derived from this study: PubMed 30727947Pimouguet C, Sitta R, Wittwer J, Hayes N, Petit-Moneger A, Dartigues JF, Helmer C. Maintenance of occupational therapy (OT) for dementia: protocol of a multi-center, randomized controlled and pragmatic trial. BMC Geriatr. 2019 Feb 6;19(1):35. doi: 10.1186/s12877-019-1046-x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing maintaining of occupational therapy in people with Alzheimer's Disease or Related Disorder, run by University Hospital, Bordeaux at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychiatric inventory (NPI) score (time frame: NPI score will be measured at 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03435705, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2023.