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

Dementia Clinical Trial

— OTSALD  

Official title:

Effectiveness of A Therapy Programme Based On The Reestablishment of Cognitive Functions on The Independence of Patients With Dementia Performing Activities of Daily Living - A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02199353
• Other study ID #: 46/2012
• Status: Completed
• Phase: N/A
• First received: July 22, 2014
• Last updated: July 24, 2014
• Start date: November 2012
• Est. completion date: April 2013

Study information

• Verified date: July 2014
• Source: University of Extremadura
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: 'Bioethics Commission of the University of Extremadura'
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: April 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dementia

Intervention

Other:
• Stimulation of Activities Daily Living
Experimental group: SADL programme which is a new treatment approach created by the authors of this study for the training of 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 treatment was carried out twice a week (Tuesday and Thursday) for 45 minutes during 5 weeks.
• Conventional ADLOccupational Therapy
Control group treatment: 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.

Locations

Country	Name	City	State
Spain	'CARE' elderly residential homes	Cáceres

Sponsors (1)

Lead Sponsor	Collaborator
University of Extremadura

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dependency level	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	after 5 weeks of treatment and after 6 weeks of follow up	No
Secondary	Cognitive level.	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.	After 5 weeks of treatment and after 6 weeks of follow up	No