Maintenance of Occupational Therapy for Patients With Alzheimer

NCT ID: NCT03435705

Last Updated: 2023-10-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-17
• Study Completion Date: 2019-11-04

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.

Conditions

Alzheimer's Disease or Related Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

intervention arm

maintaining of occupational therapy for a 4 months period

Group Type: EXPERIMENTAL

maintaining of occupational therapy

Intervention Type: BEHAVIORAL

8 home sessions over a 4 months period with caregivers' education, occupational therapy and care coordination for post intervention

control arm

usual care after the end of the recommended initial program

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

maintaining of occupational therapy

8 home sessions over a 4 months period with caregivers' education, occupational therapy and care coordination for post intervention

Intervention Type: BEHAVIORAL

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Aapam-Ssiad

Blaignan, , France

SESAME

Bordeaux, , France

Castelsanté

Casteljaloux, , France

SSIAD Hauts de garonne

Cenon, , France

SSIAD du bassin d'Arcachon

La Teste-de-Buch, , France

Vie Santé Merignac

Mérignac, , France

AMSADHG

Saint-Savin, , France

Equipe Espard

Talence, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 27983551 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30727947 (View on PubMed)

Other Identifiers

CHUBX 2016/29

Identifier Type: -

Identifier Source: org_study_id