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Randomised Controlled Trial of Unsolicited Occupational Therapy in Community-Dwelling Elderly

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00278096
First Posted: January 18, 2006
Last Update Posted: January 18, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Netherlands Organisation for Scientific Research
Information provided by:
Leiden University Medical Center
  Purpose
In this study we aim to assess whether unsolicited occupational therapy compared to no therapy can decelerate the increase in disability in high-risk elderly.

Condition Intervention
Disability Occupational Therapy Behavioral: occupational therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomised Controlled Trial of Unsolicited Occupational Therapy in Community-Dwelling Elderly

Further study details as provided by Leiden University Medical Center:

Primary Outcome Measures:
  • Score on the Groningen Activity Restriction Scale (GARS)

Secondary Outcome Measures:
  • Well-being and feelings of loneliness.

Estimated Enrollment: 400
Study Start Date: March 2000
Estimated Study Completion Date: May 2004
Detailed Description:

Community-dwelling elderly, and particularly the oldest old, are generally viewed as highly susceptible to the ‘inverse care law’. That is, those in greatest need for preventive assessment and surveillance have the highest potential benefit but are most likely to be missed. Hence, active case-finding and close follow-up might be an important strategy for maintaining the health, independence, and well-being of very elderly people who are at a particularly high risk.

In this study we aim to assess whether unsolicited occupational therapy compared to no therapy can decelerate the increase in disability in high-risk elderly. Subjects in the intervention group will be visited by an occupational therapist who provides training and education about assistive devices that are already present and will give recommendations and information about procedures, possibilities, and costs of assistive devices and community-based services. Control subjects will not be visited by an occupational therapist.

The primary outcome measure of the trial will be the score on the Groningen Activity Restriction Scale (GARS). Secondary outcome measures will be well-being and feelings of loneliness.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   85 Years to 85 Years   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age 85 years
  • living independently
  • MMSE score > 18 points

Exclusion Criteria:

  Contacts and Locations
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): NCT00278096


Sponsors and Collaborators
Leiden University Medical Center
Netherlands Organisation for Scientific Research
Investigators
Principal Investigator: Anton JM de Craen, PhD Leiden University Medical Center
  More Information

ClinicalTrials.gov Identifier: NCT00278096     History of Changes
Other Study ID Numbers: LUMC P 92/99
NWO014-91-006
First Submitted: January 13, 2006
First Posted: January 18, 2006
Last Update Posted: January 18, 2006
Last Verified: January 2006

Keywords provided by Leiden University Medical Center:
disability
occupational therapy