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

Completed

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Albacete, Spain, 02006
        • Complejo Hospitalario Universitario de Albacete

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.

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
The day of discharge from hospitalization (average 10 days)

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
The day of discharge from hospitalization (average 10 days)
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)
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)
Improvement in gait pattern
Time Frame: The day of discharge from hospitalization (average 10 days)
Increase of one level on the Holden scale between admission and discharge
The day of discharge from hospitalization (average 10 days)
Residence change
Time Frame: The day of discharge from hospitalization (average 10 days)
Institutionalisation and residence change because of a new disability
The day of discharge from hospitalization (average 10 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Primary Completion (Actual)

June 1, 2003

Study Completion (Actual)

June 1, 2003

Study Registration Dates

First Submitted

March 23, 2010

First Submitted That Met QC Criteria

March 25, 2010

First Posted (Estimate)

March 26, 2010

Study Record Updates

Last Update Posted (Estimate)

April 12, 2010

Last Update Submitted That Met QC Criteria

April 9, 2010

Last Verified

February 1, 2010

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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