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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

Tracking Information
First Submitted Date  ICMJE March 23, 2010
First Posted Date  ICMJE March 26, 2010
Last Update Posted Date April 12, 2010
Study Start Date  ICMJE November 2002
Actual Primary Completion Date June 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2010)
Functional recovery [ Time Frame: The day of discharge from hospitalization (average 10 days) ]
Recovery of 10 or more Barthel index points
Original Primary Outcome Measures  ICMJE
 (submitted: March 25, 2010)
Functional recovery [ Time Frame: 1 month ]
Recovery of 10 or more Barthel index points
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2010)
  • Confusional status [ Time Frame: The day of discharge from hospitalization (average 10 days) ]
    Confusion Assessment Method
  • Death [ Time Frame: The day of discharge from hospitalization (average 10 days) ]
  • Hospital stay [ Time Frame: 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.
  • 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
  • Residence change [ Time Frame: The day of discharge from hospitalization (average 10 days) ]
    Institutionalisation and residence change because of a new disability
Original Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2010)
  • Confusional status [ Time Frame: 1 month ]
    Confusion Assessment Method
  • Death [ Time Frame: 1 month ]
  • Hospital stay [ Time Frame: 1 month ]
  • Upper limb function improvement [ Time Frame: 1 month ]
    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.
  • Improvement in gait pattern [ Time Frame: 1 month ]
    Increase of one level on the Holden scale between admission and discharge
  • Residence change [ Time Frame: 1 month ]
    Institutionalisation and residence change because of a new disability
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of a Structured Occupational Therapy Intervention in an Acute Geriatric Unit
Official Title  ICMJE Effects of a Structured Occupational Therapy Intervention in an Acute Geriatric Unit. A Randomised Clinical Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Occupational Therapy
Intervention  ICMJE 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.

Study Arms  ICMJE
  • 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.
    Intervention: Other: Occupational therapy intervention
  • 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.
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 25, 2010)
400
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2003
Actual Primary Completion Date June 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01094002
Other Study ID Numbers  ICMJE PI02069-00
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pedro Abizanda Soler, Complejo Hospitalario Universitario de Albacete
Study Sponsor  ICMJE Complejo Hospitalario Universitario de Albacete
Collaborators  ICMJE Instituto Ciencias de la Salud, Junta de Comunidades de Castilla-La Mancha
Investigators  ICMJE Not Provided
PRS Account Complejo Hospitalario Universitario de Albacete
Verification Date February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP