DementiaOTSALDNCT02199353
Occupational Therapy Programme of Patients With Dementia Performing Activities of Daily Living
A study testing Stimulation of Activities Daily Living and Conventional ADLOccupational Therapy in people with Dementia, run by University of Extremadura at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia
- What is being tested?
- Stimulation of Activities Daily Living and Conventional ADLOccupational Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2012to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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).
- Conditions
- Dementia
- Being tested
- Stimulation of Activities Daily Living, Conventional ADLOccupational Therapy
- Keywords
- Activities of daily living, Occupational Therapy, Dementia
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stimulation of Activities Daily LivingOther
Also called Occupational therapy
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 TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Stimulation of Activities Daily Living | Experimental | 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. Receives: Other: Stimulation of Activities Daily Living |
| Conventional ADLoccupational therapy | Active comparator | 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. Receives: Other: Conventional ADLOccupational Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: after 5 weeks of treatment and after 6 weeks of follow up
Secondary outcomes (1)
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.
Measured: After 5 weeks of treatment and after 6 weeks of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2014 (estimated)
- Study startNov 2012
- Primary completionFeb 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Extremadura
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MARIA JIMENEZ PALOMARES, University of Extremadura
- Investigators
- Maria Jimenez, Professor, Principal investigator, University of Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02199353
- Sponsor's protocol ID
- 46/2012
- Acronym
- OTSALD
- Status last verified
- Jul 2014
- First submitted
- 22 Jul 2014
- Last updated
- 25 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02199353
- Acronym / sponsor ID
- OTSALD / 46/2012
- Conditions
- Dementia
- Keywords
- Activities of daily living, Occupational Therapy, Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of ExtremaduraUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 24 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stimulation of Activities Daily Living | Experimental | Other: Stimulation of Activities Daily LivingThe 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. |
| Conventional ADLoccupational therapy | Active comparator | Other: Conventional ADLOccupational TherapyThe 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stimulation of Activities Daily LivingAlso: Occupational therapyExperimental 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. | Other | Stimulation of Activities Daily Living |
| Conventional ADLOccupational TherapyControl 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. | Other | Conventional ADLoccupational therapy |
Primary outcome
Dependency level
Time frame: 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
1 secondary outcome
Cognitive level.
Time frame: After 5 weeks of treatment and after 6 weeks of follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Jimenez, Professor principal investigator
University of Extremadura
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stimulation of Activities Daily Living and Conventional ADLOccupational Therapy in people with Dementia, run by University of Extremadura at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dependency level (time frame: after 5 weeks of treatment and after 6 weeks of follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2014.