Back PainNCT01979081
Detecting and Addressing Preclinical Disability
An observational study of Back Pain and Coronary Artery Disease, run by McMaster University at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 44 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Back Pain, Coronary Artery Disease, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Tailored advice from a physiotherapist and/or an occupational therapist through the myOSCAR patient portal
- How many people
- 148 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2013to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 44 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary care center
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Back Pain, Coronary Artery Disease, Chronic Obstructive Pulmonary Disease, Diabetes, Hypertension, Multiple Sclerosis
- Being tested
- Tailored advice from a physiotherapist and/or an occupational therapist through the myOSCAR patient portal
- Medical subject headings
- Back Pain, Coronary Artery Disease, Pulmonary Disease, Chronic Obstructive, Diabetes Mellitus, Hypertension, Multiple Sclerosis, Osteoporosis, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored advice from a physiotherapist and/or an occupational therapist through the myOSCAR patient portalOther
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: Tailored advice from a physiotherapist and/or an occupational therapist through the myOSCAR patient portal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3-5 days later, 6 months, 12 months, 18 months, 3-5 days later
Secondary outcomes (3)
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.
Measured: Baseline, 3-5 days later, 6 months, 12 months, 18 months, 3-5 days later
The Rapid Assessment of Physical Activity (RAPA)
Measured: Baseline, 3-5 days later, 6 months, 12 months, 18 months, 3-5 days later
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).
Measured: Baseline, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startJan 2013
- Primary completionJun 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie Richardson, PhD, Principal investigator, McMaster UniversityLori Letts, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01979081
- Sponsor's protocol ID
- Labarge 2013-02
- Status last verified
- Apr 2018
- First submitted
- 14 May 2013
- Last updated
- 9 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detecting and Addressing Preclinical Disability
- ClinicalTrials.gov ID
- NCT01979081
- Acronym / sponsor ID
- Labarge 2013-02
- Conditions
- Back Pain, Coronary Artery Disease, Chronic Obstructive Pulmonary Disease, Diabetes, Hypertension, Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 8 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| People with chronic disease | – | Other: Tailored advice from a physiotherapist and/or an occupational therapist through the myOSCAR patient portalParticipants 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). |
| People without chronic disease | – | Other: Tailored advice from a physiotherapist and/or an occupational therapist through the myOSCAR patient portalParticipants greater than or equal to 65 years of age without a chronic disease. |
Who may qualify
- Ages
- 44 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care center
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Any evidence of cognitive impairment
- Unable to travel to the clinic
- Awaiting long-term care
- Planning to relocate
- Experiencing an acute illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored advice from a physiotherapist and/or an occupational therapist through the myOSCAR patient portal | Other | People with chronic disease, People without chronic disease |
Primary outcome
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.
3 secondary outcomes
Mobility Survey
Time frame: 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
Patient Specific Functional Scale (PSFS)
Time frame: Baseline, 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Richardson, PhD principal investigator
McMaster University
Lori Letts, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Back Pain and Coronary Artery Disease, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Functioning Inventory (time frame: Baseline, 3-5 days later, 6 months, 12 months, 18 months, 3-5 days later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2018.