- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01094002
Effects of a Structured Occupational Therapy Intervention in an Acute Geriatric Unit
Effects of a Structured Occupational Therapy Intervention in an Acute Geriatric Unit. A Randomised Clinical Trial
Objectives: To compare the benefits of structured occupational therapy intervention by a single geriatric therapist with the benefits of the conventional treatment model in the functional recovery of patients admitted to an acute geriatric unit.
Design: Non-pharmacological randomised clinical trial. Setting: Acute Geriatric Unit, Albacete, Spain. Participants: The trial included 400 patients admitted consecutively over 6 months to an acute geriatric unit for acute illness or exacerbation of a chronic medical condition. Participants were randomised to the occupational therapy intervention or conventional treatment model group; 198 patients received occupational therapy. All patients completed the study. The mean age was 83.5, and 56.8% were women.
Interventions: Needs assessment, iatrogenic prevention, retraining in basic and instrumental activities of daily living, assessment of need for technical aids, instruction for primary caregiver in patient mobilisation techniques, and structured social and occupational motivation as per protocol in three groups of patients (cardiopulmonary disease, stroke, and other conditions) 5 days a week, 30 to 45 minutes a day over the entire hospital stay.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Albacete, Spain, 02006
- Complejo Hospitalario Universitario de Albacete
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All patients age 65 or older consecutively admitted to the acute geriatric unit at the Complejo Hospitalario Universitario in Albacete, Spain, between November 2002 and June 2003 for an acute medical illness or exacerbation of a previous chronic condition
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Occupational therapy intervention (OTI)
198 subjects.
The OTI schedule consisted of a daily 45-minute session, Monday through Friday, for the duration of hospitalisation.
Activities were carried out in a structured manner and varied according to need and day of admission.
On the first day, the patient's needs were analysed, including the need for iatrogenic prevention, retraining in basic and instrumental activities of daily living, technical aids, instruct the primary caregiver in patient mobilisation techniques, and social and occupational motivation.
All OTI participants received an average of 5 sessions during hospitalisation.
|
Day 1: Physical, functional, cognitive, social, and emotional assessment. Need analysis for iatrogenic prevention, retraining in BADL and IADL, technical aids, instructions in patient mobilisation techniques, and for social and occupational motivation. Day 2 until discharge: 45-minute sessions. Cognitive stimulation and confusional syndrome prevention, instructions to the caregivers on how to prevent complications such as immobility, delirium, falls, urinary incontinence, or pressure sores, and patient stimulation, retraining in activities of daily living. Day of discharge: Instruction for caregivers on managing the patient's residual deficits, assessment for technical aids, recommendations for patient increased independence in ADL, and social and occupational activities. |
|
No Intervention: Conventional treatment model group
202 subjects.
All subjects received medical treatment, nursing care, physical therapy, and social assistance in accordance with the usual practice of the geriatrics unit.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional recovery
Time Frame: The day of discharge from hospitalization (average 10 days)
|
Recovery of 10 or more Barthel index points
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The day of discharge from hospitalization (average 10 days)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Confusional status
Time Frame: The day of discharge from hospitalization (average 10 days)
|
Confusion Assessment Method
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The day of discharge from hospitalization (average 10 days)
|
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Death
Time Frame: The day of discharge from hospitalization (average 10 days)
|
The day of discharge from hospitalization (average 10 days)
|
|
|
Hospital stay
Time Frame: The day of discharge from hospitalization (average 10 days)
|
The day of discharge from hospitalization (average 10 days)
|
|
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Upper limb function improvement
Time Frame: The day of discharge from hospitalization (average 10 days)
|
Touching either shoulder blade with the hand, picking up a full glass of water, unbuttoning a button, and cutting with a knife.
Improvement was defined as the ability to perform more such functions at discharge compared with admission.
|
The day of discharge from hospitalization (average 10 days)
|
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Improvement in gait pattern
Time Frame: The day of discharge from hospitalization (average 10 days)
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Increase of one level on the Holden scale between admission and discharge
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The day of discharge from hospitalization (average 10 days)
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Residence change
Time Frame: The day of discharge from hospitalization (average 10 days)
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Institutionalisation and residence change because of a new disability
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The day of discharge from hospitalization (average 10 days)
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PI02069-00
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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