Detecting and Addressing Preclinical Disability

April 5, 2018 updated by: McMaster University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

148

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8W 3L2
        • Stonechurch Family Health Centre

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

44 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary care center

Description

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
People with chronic disease
Participants greater than or equal to 44 years of age with a chronic disease (diabetes, heart disease, stroke, hypertension, osteoporosis, osteoarthritis, rheumatoid arthritis, chronic obstructive pulmonary disease, back pain, Multiple Sclerosis, Parkinson's Disease).
Other: Tailored advice from a physiotherapist and/or an occupational therapist through the myOSCAR patient portal
People without chronic disease
Participants greater than or equal to 65 years of age without a chronic disease.
Other: Tailored advice from a physiotherapist and/or an occupational therapist through the myOSCAR patient portal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Functioning Inventory
Time Frame: Baseline, 3-5 days later, 6 months, 12 months, 18 months, 3-5 days later
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mobility Survey
Time Frame: Baseline, 3-5 days later, 6 months, 12 months, 18 months, 3-5 days later
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
The Rapid Assessment of Physical Activity (RAPA)
Time Frame: Baseline, 3-5 days later, 6 months, 12 months, 18 months, 3-5 days later
Baseline, 3-5 days later, 6 months, 12 months, 18 months, 3-5 days later
Patient Specific Functional Scale (PSFS)
Time Frame: Baseline, 18 months
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

Other Outcome Measures

Outcome Measure
Time Frame
Center for Epidemiological Studies Depression Scale (CESD-R)
Time Frame: Baseline, 18 months
Baseline, 18 months
Brief Pain Inventory
Time Frame: Baseline, 18 months
Baseline, 18 months

Collaborators and Investigators

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

Sponsor

McMaster University

Investigators

  • Principal Investigator: Julie Richardson, PhD, McMaster University
  • Principal Investigator: Lori Letts, PhD, McMaster University

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

January 1, 2013

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

May 14, 2013

First Submitted That Met QC Criteria

November 3, 2013

First Posted (Estimate)

November 8, 2013

Study Record Updates

Last Update Posted (Actual)

April 9, 2018

Last Update Submitted That Met QC Criteria

April 5, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Labarge 2013-02

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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