NCT01094002

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2002

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
6.8 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 26, 2010

Completed
Last Updated

April 12, 2010

Status Verified

February 1, 2010

Enrollment Period

7 months

First QC Date

March 23, 2010

Last Update Submit

April 9, 2010

Conditions

Keywords

OCCUPATIONAL THERAPYRANDOMISED CLINICAL TRIALAGEDPATIENT CARE

Outcome Measures

Primary Outcomes (1)

  • Functional recovery

    Recovery of 10 or more Barthel index points

    The day of discharge from hospitalization (average 10 days)

Secondary Outcomes (6)

  • Confusional status

    The day of discharge from hospitalization (average 10 days)

  • Death

    The day of discharge from hospitalization (average 10 days)

  • Hospital stay

    The day of discharge from hospitalization (average 10 days)

  • Upper limb function improvement

    The day of discharge from hospitalization (average 10 days)

  • Improvement in gait pattern

    The day of discharge from hospitalization (average 10 days)

  • +1 more secondary outcomes

Study Arms (2)

Occupational therapy intervention (OTI)

EXPERIMENTAL

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

Conventional treatment model group

NO INTERVENTION

202 subjects. All subjects received medical treatment, nursing care, physical therapy, and social assistance in accordance with the usual practice of the geriatrics unit.

Interventions

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.

Occupational therapy intervention (OTI)

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Complejo Hospitalario Universitario de Albacete

Albacete, Albacete, 02006, Spain

Location

Related Publications (1)

  • Abizanda P, Navarro JL, Romero L, Leon M, Sanchez-Jurado PM, Dominguez L. Upper extremity function, an independent predictor of adverse events in hospitalized elderly. Gerontology. 2007;53(5):267-73. doi: 10.1159/000102541. Epub 2007 May 8.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 23, 2010

First Posted

March 26, 2010

Study Start

November 1, 2002

Primary Completion

June 1, 2003

Study Completion

June 1, 2003

Last Updated

April 12, 2010

Record last verified: 2010-02

Locations