Detecting and Addressing Preclinical Disability

Stroke Clinical Trial

Official title:

Detecting and Addressing Preclinical Disability

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01979081
• Other study ID #: Labarge 2013-02
• Status: Completed
• First received: May 14, 2013
• Last updated: April 5, 2018
• Start date: January 2013
• Est. completion date: December 2017

Study information

• Verified date: April 2018
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The Physical Functioning Inventory (PFI) is a standardized patient reported outcome measure that assesses preclinical disability. Preclinical disability is a functional state in which people are still able to complete daily living tasks (e.g., walking, bathing) but are changing the frequency or modifying the way that they complete the tasks. The investigators have done some preliminary research using the PFI as an online monitoring tool (Richardson 2012), but further study is required to examine its psychometric properties and its suitability for use as a primary outcome measure. This measurement study has been designed to identify the optimal number of items on the PFI and to determine the reliability, validity, and responsiveness of the PFI when administered to a sample of adults and older adults both with and without chronic conditions. This project will also allow us to evaluate the use of self-monitoring of physical function and the added value of rehabilitation professionals to support self-monitoring. Using the results of the PFI, the investigators aim to develop a "tailored" population-based rehabilitation self-management intervention delivered through a secure messaging system in the patient's electronic personal health record (myOSCAR) that focuses on the early detection and prevention of preclinical disability.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 44 Years to 100 Years

Eligibility

Inclusion Criteria:

• Greater than or equal to 44 years of age

• Able to communicate in English

• Have had at least 3 physician visits in the last year

• Are able to access an email address independently

• Have a chronic disease

Exclusion Criteria:

• Any evidence of cognitive impairment

• Unable to travel to the clinic

• Awaiting long-term care

• Planning to relocate

• Experiencing an acute illness

• Are receiving palliative care

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Back Pain
• Chronic Obstructive Pulmonary Disease
• Coronary Artery Disease
• Coronary Disease
• Diabetes
• Hypertension
• Lung Diseases
• Lung Diseases, Obstructive
• Multiple Sclerosis
• Myocardial Ischemia
• Osteoarthritis
• Osteoporosis
• Pulmonary Disease, Chronic Obstructive
• Rheumatoid Arthritis
• Stroke

Intervention

Other:
• Tailored advice from a physiotherapist and/or an occupational therapist through the myOSCAR patient portal

Locations

Country	Name	City	State
Canada	Stonechurch Family Health Centre	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Center for Epidemiological Studies Depression Scale (CESD-R)		Baseline, 18 months
Other	Brief Pain Inventory		Baseline, 18 months
Primary	Physical Functioning Inventory	The PFI will be administered at baseline, then again 3-5 days later to assess test-retest reliability. It will then be administered at 6 months, 12 months and 18 months to determine its longitudinal validity. It will be administered a final time 3-5 days after the 18 month time frame to re-evaluate the measures test-retest reliability.	Baseline, 3-5 days later, 6 months, 12 months, 18 months, 3-5 days later
Secondary	Mobility Survey	The Mobility Survey has been created from work by Manty (2007). Self-reported mobility is determined by asking participants to rate their ability to walk 2.0km, walk 0.5km, and climb up 1 flight of stairs on a scale of 1 (able to manage without difficulty) to 5 (unable to manage even with help). To identify persons at an early stage of mobility limitation (preclinical mobility limitation), additional questions were posed to participants who reported no task difficulty. The questions concerned the modification of task performance and the alternatives given were resting in the middle of the performance, using an aid, taking support from handrails, having reduced the frequency of performing the task, having slowed down performance of the task, experiencing tiredness when performing the task, or some other change in carrying out the task.	Baseline, 3-5 days later, 6 months, 12 months, 18 months, 3-5 days later
Secondary	The Rapid Assessment of Physical Activity (RAPA)		Baseline, 3-5 days later, 6 months, 12 months, 18 months, 3-5 days later
Secondary	Patient Specific Functional Scale (PSFS)	The participant is asked to identify up to 5 important activities that they are unable to do or have difficulty with because of their health. For each of the activities the participant is asked to rate their ability to perform that activity on a scale of 0 (unable to perform the activity) to 10 (able to perform the activity like I always have).	Baseline, 18 months