NCT02199353

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 24, 2014

Completed
Last Updated

July 25, 2014

Status Verified

July 1, 2014

Enrollment Period

3 months

First QC Date

July 22, 2014

Last Update Submit

July 24, 2014

Conditions

Keywords

Activities of daily living, Occupational Therapy, Dementia

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Cognitive level.

    After 5 weeks of treatment and after 6 weeks of follow up

Study Arms (2)

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.

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.

Other: Conventional ADLOccupational Therapy

Interventions

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.

Also known as: Occupational therapy
Stimulation of Activities Daily Living

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.

Conventional ADLoccupational therapy

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

'CARE' elderly residential homes

Cáceres, Cáceres, 10004, Spain

Location

MeSH Terms

Conditions

Dementia

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Officials

  • Maria Jimenez, Professor

    University of Extremadura

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Profesor of Occupational Therapy

Study Record Dates

First Submitted

July 22, 2014

First Posted

July 24, 2014

Study Start

November 1, 2012

Primary Completion

February 1, 2013

Study Completion

April 1, 2013

Last Updated

July 25, 2014

Record last verified: 2014-07

Locations