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

This study has been completed.
Sponsor:
Collaborator:
Netherlands Organisation for Scientific Research
Information provided by:
Leiden University Medical Center
ClinicalTrials.gov Identifier:
NCT00278096
First received: January 13, 2006
Last updated: NA
Last verified: January 2006
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Ages Eligible for Study:   85 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00278096     History of Changes
Other Study ID Numbers: LUMC P 92/99, NWO014-91-006
Study First Received: January 13, 2006
Last Updated: January 13, 2006
Health Authority: Netherlands: Independent Ethics Committee

Keywords provided by Leiden University Medical Center:
disability
occupational therapy

ClinicalTrials.gov processed this record on April 17, 2014