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Completed

NCT Number: NCT01094002

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Complejo Hospitalario Universitario de Albacete

Albacete, 02006, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Occupational therapy intervention

Other

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.

Primary outcomes

  1. Functional recovery

    Time frame: The day of discharge from hospitalization (average 10 days)

    Recovery of 10 or more Barthel index points

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Complejo Hospitalario Universitario de Albacete

Other

Collaborators

  • Instituto Ciencias de la Salud, Junta de Comunidades de Castilla-La Mancha

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Mar 26, 2010
Registry last updated
Apr 12, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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