Occupational Therapy Programme of Patients With Dementia Performing Activities of Daily Living

Not Applicable

Completed

• Conditions: Dementia
• Interventions: Other: Conventional ADLOccupational Therapy; Other: Stimulation of Activities Daily Living

• Registration Number: NCT02199353
• Lead Sponsor: University of Extremadura

Brief Summary

To assess the effectiveness of the Stimulation of Activities of Daily Living (SADL) Occupational Therapy programme on the independence of ADL by persons with dementia who are institutionalized. This programme is based on the recovery of the cognitive functions.

Detailed Description

This study is a longitudinal and prospective clinical trial approved by the bioethics Commission of the University of Extremadura. 58 senior citizens institutionalized with dementia in residential homes in Extremadura (Spain) received a treatment focusing on activities of daily living with the SADL programme and with conventional occupational therapy during 5 weeks. The studied variables were the cognitive level and the independence level performing ADL. The variables were measured by an occupational therapist independent to the study at baseline, after 5 weeks of experimental treatment and 6 weeks after the treatment was completed. The standardized tests used were Barthel Index, Lobo's Cognoscitive mini test, Lawton and Brody Scale and Global Deterioration Scale (GDS).

Study Timeline

• Study Start: 2012-11
• Primary Completion: 2013-02
• Study Completion: 2013-04
• Status Verified: 2014-07
• Study First Submitted: 2014-07-22
• Study First Submitted QC: 2014-07-22
• Study First Posted: 2014-07-24
• Last Update Submitted: 2014-07-24
• Last Update Posted: 2014-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• Institutionalization in residential homes at least 6 months before the commencement of the study.
• Diagnosis of dementia for at least one year according to the Diagnostic and Statistical Manual of Mental Disorders (DMS IV) criteria.
• Over 60 years old.
• Barthel Index scores greater than or equal to 40%.
• Lobo´s Cognitive Mini Test scores greater than or equal to 15 points.
• To be included in the BADL intervention programme of Occupational therapy in the previous 6 months and to have the informed consent signed by the legal tutor.

Exclusion Criteria

• To present psychological or behavior symptoms diagnosed by a doctor.
• Barthel Index scores less than 40%
• Not being included in the BADL intervention programme of Occupational therapy in the previous 6 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional ADLoccupational therapy	Conventional ADLOccupational Therapy	The control group treatment was based on a conventional occupational therapy intervention for the management of ADL deficits. The compensation approach was used and environment modifications and simplification of activities were applied as the intervention method. The treatment was carried out twice a week (Tuesday and Thursday) for 45 minutes during 5 weeks.
Stimulation of Activities Daily Living	Stimulation of Activities Daily Living	The experimental group received the Stimulation of Activities of Daily Living (SADL) programme which is a new treatment approach created by the authors of this study for the training of activities of daily living (ADL) through cognitive intervention. The programme is based on the reestablishment of the cognitive functions implied in the performance of basic activities of daily living. The sequence of the sessions was always the same, varying the activities, subject, cognitive functions and BADL to work on. Each session started with an activity of temporal and space orientation, continued with the performance of the specific activity of the session and finished with a reminiscence activity. The treatment was applied twice a week (Tuesday and Thursday) for 45 minutes during 5 weeks.

Primary Outcome Measures

Name	Time	Method
Dependency level	after 5 weeks of treatment and after 6 weeks of follow up	In order to assess the basic activities of daily living (BADL), Barthel Index published in 1.965 by Mahoney y Barthel was applied. This scale provides information at a global level with the general scores (dependence level) and at a specific level with each item's score. A score of less than 20 means total dependence, 20-35 scores mean severe dependence, 40-55 scores mean moderate dependence, equal or over 60 means mild dependency and 100 means independence. This allows the assessment of any changes in each basic activity area evaluated with this scale

Secondary Outcome Measures

Name	Time	Method
Cognitive level.	After 5 weeks of treatment and after 6 weeks of follow up	To assess the cognitive level and guarantee the homogeneity of the sample, the adapted and validated Spanish version of the Mini Mental Status Examination (MMSE) test by Lobo et al was used. The Global Deterioration Scale (GDS) designed by Reisberg et al was also used to determine the deterioration level.

Trial Locations

Locations (1)

'CARE' elderly residential homes; 🇪🇸 Cáceres, Spain