Clinical trial NCT03435705: Maintenance of Occupational Therapy for Patients With Alzheimer
Official title: Maintenance of Occupational Therapy for Patients With Alzheimer: A Pragmatic Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease or Related Disorder
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 240
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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.

Primary outcomes:
measure: Neuropsychiatric inventory (NPI) score
timeFrame: NPI score will be measured at 7 months
Secondary outcomes:
measure: Neuropsychiatric inventory (NPI) score
timeFrame: at inclusion
measure: Neuropsychiatric inventory (NPI) score
timeFrame: at 3 months
measure: Neuropsychiatric inventory (NPI) score
timeFrame: at 12 months
measure: The functional autonomy measured by the Disability Assessment in Dementia (DAD scale).
timeFrame: at inlcusion
measure: The functional autonomy measured by the Disability Assessment in Dementia (DAD scale).
timeFrame: at 3 months
measure: The functional autonomy measured by the Disability Assessment in Dementia (DAD scale).
timeFrame: at 7 months
measure: The functional autonomy measured by the Disability Assessment in Dementia (DAD scale).
timeFrame: at 12 months
measure: Quality of life measured by the Quality of Life in Alzheimer's Disease scale.
timeFrame: at 3 months
measure: Quality of life measured by the Quality of Life in Alzheimer's Disease scale.
timeFrame: at 7 months
measure: Quality of life measured by the Quality of Life in Alzheimer's Disease scale.
timeFrame: at 12 months
measure: Depression of the patient via the Montgomery-Asberg Depression Rating Scale (MADRS).
timeFrame: at 3 months
measure: Depression of the patient via the Montgomery-Asberg Depression Rating Scale (MADRS).
timeFrame: at 7 months
measure: Depression of the patient via the Montgomery-Asberg Depression Rating Scale (MADRS).
timeFrame: at 12 months
measure: Apathy of the patient via the Apathy inventory.
timeFrame: at 3 months
measure: Apathy of the patient via the Apathy inventory.
timeFrame: at 7 months
measure: Apathy of the patient via the Apathy inventory.
timeFrame: at 12 months
measure: Mortality and institutionalization of patients.
timeFrame: at 3 months
measure: Mortality and institutionalization of patients.
timeFrame: at 7 months
measure: Mortality and institutionalization of patients.
timeFrame: at 12 months
measure: The care processes.
timeFrame: at 3 months
measure: The care processes.
timeFrame: at 7 months
measure: The care processes.
timeFrame: at 12 months
measure: The caregiver burden via the Burden Interview with Zarit
timeFrame: at 3 months
measure: The caregiver burden via the Burden Interview with Zarit
timeFrame: at 7 months
measure: The caregiver burden via the Burden Interview with Zarit
timeFrame: at 12 months
measure: The sense of competence of the caregivers
timeFrame: at 3 months
measure: The sense of competence of the caregivers
timeFrame: at 7 months
measure: The sense of competence of the caregivers
timeFrame: at 12 months
measure: Patient care consumption measured by the RUD Lite scale
timeFrame: at 3 months
measure: Patient care consumption measured by the RUD Lite scale
timeFrame: at 7 months
measure: Patient care consumption measured by the RUD Lite scale
timeFrame: at 12 months
measure: The total cost (health and social) of patient care in each of the groups
timeFrame: at 7 months
measure: The total cost (health and social) of patient care in each of the groups
timeFrame: at 12 months
measure: The cost per disorder behavior avoided
timeFrame: at 7 months
measure: The cost per disorder behavior avoided
timeFrame: at 12 months
measure: The cost related to the consequences in terms of quality of life of the patient
timeFrame: at 7 months
measure: The cost related to the consequences in terms of quality of life of the patient
timeFrame: at 12 months
Other outcomes:
Locations:
city: Blaignan
country: France
facility: Aapam-Ssiad
city: Bordeaux
country: France
facility: SESAME
city: Casteljaloux
country: France
facility: Castelsanté
city: Cenon
country: France
facility: SSIAD Hauts de garonne
city: La Teste-de-Buch
country: France
facility: SSIAD du bassin d'Arcachon
city: Mérignac
country: France
facility: Vie Santé Merignac
city: Saint Savin
country: France
facility: AMSADHG
city: Talence
country: France
facility: Equipe Espard
Study officials:
References:
citation: 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.
citation: Pimouguet 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.