Clinical trial NCT01979081: Detecting and Addressing Preclinical Disability
Official title: Detecting and Addressing Preclinical Disability
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Back Pain
Coronary Artery Disease
Chronic Obstructive Pulmonary Disease
Diabetes
Hypertension
Multiple Sclerosis
Osteoporosis
Osteoarthritis
Rheumatoid Arthritis
Stroke
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2013-11-08
Enrollment: 148
Sex: ALL
Minimum age (years): 44
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care center

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Physical Functioning Inventory
timeFrame: Baseline, 3-5 days later, 6 months, 12 months, 18 months, 3-5 days later
Secondary outcomes:
measure: Mobility Survey
timeFrame: Baseline, 3-5 days later, 6 months, 12 months, 18 months, 3-5 days later
measure: The Rapid Assessment of Physical Activity (RAPA)
timeFrame: Baseline, 3-5 days later, 6 months, 12 months, 18 months, 3-5 days later
measure: Patient Specific Functional Scale (PSFS)
timeFrame: Baseline, 18 months
Other outcomes:
measure: Center for Epidemiological Studies Depression Scale (CESD-R)
timeFrame: Baseline, 18 months
measure: Brief Pain Inventory
timeFrame: Baseline, 18 months
Locations:
city: Hamilton
country: Canada
facility: Stonechurch Family Health Centre
state: Ontario
Study officials:
affiliation: McMaster University
name: Julie Richardson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Lori Letts, PhD
role: PRINCIPAL_INVESTIGATOR
References: