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Effects of a Structured Occupational Therapy Intervention in an Acute Geriatric Unit

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ClinicalTrials.gov Identifier: NCT01094002
Recruitment Status : Completed
First Posted : March 26, 2010
Last Update Posted : April 12, 2010
Sponsor:
Collaborator:
Instituto Ciencias de la Salud, Junta de Comunidades de Castilla-La Mancha
Information provided by:
Complejo Hospitalario Universitario de Albacete

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Occupational Therapy Other: Occupational therapy intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of a Structured Occupational Therapy Intervention in an Acute Geriatric Unit. A Randomised Clinical Trial
Study Start Date : November 2002
Actual Primary Completion Date : June 2003
Actual Study Completion Date : June 2003

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.
Other: Occupational therapy intervention

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.



Primary Outcome Measures :
  1. Functional recovery [ Time Frame: The day of discharge from hospitalization (average 10 days) ]
    Recovery of 10 or more Barthel index points


Secondary Outcome Measures :
  1. Confusional status [ Time Frame: The day of discharge from hospitalization (average 10 days) ]
    Confusion Assessment Method

  2. Death [ Time Frame: The day of discharge from hospitalization (average 10 days) ]
  3. Hospital stay [ Time Frame: The day of discharge from hospitalization (average 10 days) ]
  4. 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.

  5. 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

  6. Residence change [ Time Frame: The day of discharge from hospitalization (average 10 days) ]
    Institutionalisation and residence change because of a new disability



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01094002


Locations
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Spain
Complejo Hospitalario Universitario de Albacete
Albacete, Spain, 02006
Sponsors and Collaborators
Complejo Hospitalario Universitario de Albacete
Instituto Ciencias de la Salud, Junta de Comunidades de Castilla-La Mancha

Publications of Results:
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Responsible Party: Pedro Abizanda Soler, Complejo Hospitalario Universitario de Albacete
ClinicalTrials.gov Identifier: NCT01094002     History of Changes
Other Study ID Numbers: PI02069-00
First Posted: March 26, 2010    Key Record Dates
Last Update Posted: April 12, 2010
Last Verified: February 2010

Keywords provided by Complejo Hospitalario Universitario de Albacete:
OCCUPATIONAL THERAPY
RANDOMISED CLINICAL TRIAL
AGED
PATIENT CARE