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Completed

NCT Number: NCT01979081

Detecting and Addressing Preclinical Disability

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.

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Key information

Conditions

Back Pain Arterial Occlusive Diseases Arteriosclerosis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Autoimmune Diseases of the Nervous System Bone Diseases Bone Diseases, Metabolic Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Chronic Disease Chronic Obstructive Pulmonary Disease Connective Tissue Diseases Coronary Artery Disease Coronary Disease Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Diabetes Diabetes Mellitus Disease Attributes Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Hypertension Immune System Diseases Joint Diseases Lung Diseases Lung Diseases, Obstructive Metabolic Diseases Multiple Sclerosis Musculoskeletal Diseases Myocardial Ischemia Nervous System Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Osteoarthritis Osteoporosis Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Rheumatic Diseases Rheumatoid Arthritis Signs and Symptoms Skin and Connective Tissue Diseases Stroke Vascular Diseases

Age range

44 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Stonechurch Family Health Centre

Hamilton, Ontario, L8W 3L2, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. The Rapid Assessment of Physical Activity (RAPA)

    Time frame: Baseline, 3-5 days later, 6 months, 12 months, 18 months, 3-5 days later

  3. 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).

Other outcomes

  1. Center for Epidemiological Studies Depression Scale (CESD-R)

    Time frame: Baseline, 18 months

  2. Brief Pain Inventory

    Time frame: Baseline, 18 months

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Nov 8, 2013
Registry last updated
Apr 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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