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

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ClinicalTrials.gov Identifier: NCT00278096
Recruitment Status : Completed
First Posted : January 18, 2006
Last Update Posted : January 18, 2006
Sponsor:
Collaborator:
Netherlands Organisation for Scientific Research
Information provided by:
Leiden University Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Disability Occupational Therapy Behavioral: occupational therapy Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Enrollment : 400 participants
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
Study Start Date : March 2000
Study Completion Date : May 2004



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

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


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

Inclusion Criteria:

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

Exclusion Criteria:


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

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

Keywords provided by Leiden University Medical Center:
disability
occupational therapy