Back to resultsOccupational Therapy Programme of Patients With Dementia Performing Activities of Daily Living (OTSALD)
Primary Purpose
Dementia
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Stimulation of Activities Daily Living
Conventional ADLOccupational Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Dementia focused on measuring Activities of daily living, Occupational Therapy, Dementia
Eligibility Criteria
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.
Sites / Locations
- 'CARE' elderly residential homes
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Stimulation of Activities Daily Living
Conventional ADLoccupational therapy
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02199353
Brief Title
Occupational Therapy Programme of Patients With Dementia Performing Activities of Daily Living
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Extremadura
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
Activities of daily living, Occupational Therapy, Dementia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stimulation of Activities Daily Living
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional ADLoccupational therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Stimulation of Activities Daily Living
Other Intervention Name(s)
Occupational therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional ADLOccupational Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dependency level
Description
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
Time Frame
after 5 weeks of treatment and after 6 weeks of follow up
Secondary Outcome Measure Information:
Title
Cognitive level.
Description
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.
Time Frame
After 5 weeks of treatment and after 6 weeks of follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Jimenez, Professor
Organizational Affiliation
University of Extremadura
Official's Role
Principal Investigator
Facility Information:
Facility Name
'CARE' elderly residential homes
City
Cáceres
ZIP/Postal Code
10004
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Occupational Therapy Programme of Patients With Dementia Performing Activities of Daily Living
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