Assessing Patient Care Through Routine Use of Patient-Reported Outcomes

Falls Clinical Trial

Official title:

Routine Use of Patient Reported Outcomes Among Older Adults at High Risk of Falls: A 12-Month Cohort Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01008579
• Other study ID #: H09-01655
• Status: Withdrawn
• Phase: N/A
• First received: November 4, 2009
• Last updated: November 2, 2017
• Start date: December 2009
• Est. completion date: April 2011

Study information

• Verified date: November 2017
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Patient reported outcome measures (PROMs) are assessments of health status or health-related quality of life. The EuroQol-5D (EQ5D) is an example of a generic instrument to assess health-related quality of life. The investigators will use the EQ5D in the Falls Prevention Clinic as part of routine clinical assessment at baseline, 6 months and 12 months to track patient care in a cohort of 300 older adults who are at high-risk of falls.

Description:

1. Purpose: We will use the EQ5D in the Falls Prevention Clinic as part of routine clinical assessment at baseline, 6-months and 12-months to track patient care in a cohort of 300 older adults who are at high-risk of falls.

2. Objectives:

O1: Our primary objective is to use a routinely administered patient reported outcomes measure, the EuroQol-5D (EQ-5D), in older adults at high risk of falls to determine patients self-reported health status over a 12-month followup period.

O2: Our secondary objective is to develop an explanatory model and a predictive model of covariates that explain significant gains or losses in health related quality of life.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

1. Referred to falls clinic for assessment by general practitioner or emergency department physician.

2. Index fall presentation not due to overwhelming force resulting in presentation to Emergency Department or general practitioner (including syncopal presentation, see below).

3. At least 70 years of age.

4. No progressive neurological disorder (e.g. Dementia, Parkinson's, Alzheimer's).

5. Community dwelling (within Vancouver and Burnaby only).

6. Mini Mental State Examination Score of at least 24.

7. Walk at least 3 meters.

8. Has at least one of the following 'high-risk' criteria:

• At least one other non-syncopal fall in the past 12 months

• PPA of at least 1.0 (using dominant score for strength test)

• TUG of at least 15 seconds

9. Life expectancy of greater than 12 months as determined by the geriatrician.

Exclusion Criteria:

1. Any patients who do not meet the inclusion criteria specified above will be excluded from assessment at the Falls Prevention Clinic.

Related Conditions & MeSH terms

• Falls

Locations

Country	Name	City	State
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada,