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

Occupational Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00278096
• Other study ID #: LUMC P 92/99
• Secondary ID: NWO014-91-006
• Status: Completed
• Phase: N/A
• First received: January 13, 2006
• Last updated: January 13, 2006
• Start date: March 2000
• Est. completion date: May 2004

Study information

• Verified date: January 2006
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Independent Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: May 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 85 Years to 85 Years

Eligibility

Inclusion Criteria:

• age 85 years

• living independently

• MMSE score > 18 points

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Disability
• Occupational Therapy

Intervention

Behavioral:
• occupational therapy

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Leiden University Medical Center	Netherlands Organisation for Scientific Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score on the Groningen Activity Restriction Scale (GARS)
Secondary	Well-being and feelings of loneliness.