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

January 13, 2006 updated by: Leiden University Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment

400

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

85 years to 85 years (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Score on the Groningen Activity Restriction Scale (GARS)

Secondary Outcome Measures

Outcome Measure
Well-being and feelings of loneliness.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leiden University Medical Center

Collaborators

Netherlands Organisation for Scientific Research

Investigators

  • Principal Investigator: Anton JM de Craen, PhD, Leiden University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2000

Study Completion

May 1, 2004

Study Registration Dates

First Submitted

January 13, 2006

First Submitted That Met QC Criteria

January 13, 2006

First Posted (Estimate)

January 18, 2006

Study Record Updates

Last Update Posted (Estimate)

January 18, 2006

Last Update Submitted That Met QC Criteria

January 13, 2006

Last Verified

January 1, 2006

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • LUMC P 92/99
  • NWO014-91-006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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