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

Occupational Therapy Clinical Trial

Official title:

Effects of a Structured Occupational Therapy Intervention in an Acute Geriatric Unit. A Randomised Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01094002
• Other study ID #: PI02069-00
• Status: Completed
• Phase: N/A
• First received: March 23, 2010
• Last updated: April 9, 2010
• Start date: November 2002
• Est. completion date: June 2003

Study information

• Verified date: February 2010
• Source: Complejo Hospitalario Universitario de Albacete
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: June 2003
• Est. primary completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Occupational Therapy

Intervention

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.

Locations

Country	Name	City	State
Spain	Complejo Hospitalario Universitario de Albacete	Albacete

Sponsors (2)

Lead Sponsor	Collaborator
Complejo Hospitalario Universitario de Albacete	Instituto Ciencias de la Salud, Junta de Comunidades de Castilla-La Mancha

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Abizanda P, Navarro JL, Romero L, León M, Sánchez-Jurado PM, Domínguez L. Upper extremity function, an independent predictor of adverse events in hospitalized elderly. Gerontology. 2007;53(5):267-73. Epub 2007 May 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional recovery	Recovery of 10 or more Barthel index points	The day of discharge from hospitalization (average 10 days)	No
Secondary	Confusional status	Confusion Assessment Method	The day of discharge from hospitalization (average 10 days)	No
Secondary	Death		The day of discharge from hospitalization (average 10 days)	No
Secondary	Hospital stay		The day of discharge from hospitalization (average 10 days)	No
Secondary	Upper limb function improvement	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)	No
Secondary	Improvement in gait pattern	Increase of one level on the Holden scale between admission and discharge	The day of discharge from hospitalization (average 10 days)	No
Secondary	Residence change	Institutionalisation and residence change because of a new disability	The day of discharge from hospitalization (average 10 days)	No