- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04494711
Physical Literacy and Rehabilitation
A Multi-phased Technology Integrated Physical Literacy Program Targeting Adults With Multimorbidity. A Knowledge Translation Project
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The objectives of this three stage mixed methods study is to:
- Develop a new physical literacy framework, with the help of health professionals and end-users that promotes optimal physical functioning for adults.
- Develop a population-based health intervention using rehabilitation strategies that are delivered virtually to increase physical literacy for adults.
The first 2 qualitative studies will be used to inform the third quantitative intervention.
First, an on-line consensus approach with physiotherapy leaders, rehabilitation researchers and public health experts will be used to identify a new physical literacy framework as it relates to adults.
Second, virtual semi-structured interviews with working adults who are living with 2 or more chronic conditions will determine how aging adults frame physical literacy in their life, specifically with the management of chronic conditions.
Lastly, working adults with 2 or more chronic conditions will participate in a 5-week physical literacy program. Multifaceted knowledge translation strategies including; "walk and talk" with a neighbour or friend, podcasts and on-line mobility challenges will be utilized.
It is anticipated the intervention will improve important physical literacy outcomes such as; physical competence, function, mobility, motivation, awareness, and self-efficacy.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Hamilton, Canada, L8S4L8
- Celeste Petrusevski
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Subjects will be screened by the primary researcher for the following inclusion criteria:
- Diagnosed from a physician with 2 or more chronic conditions and have lived with the conditions for ≥1 year
- Able to speak English
- Employed full time as a teacher in the Hamilton-Wentworth School Board, Ontario between the ages of 45 and 65 years.
- Describe themselves as moderately physically active or inactive over the past 12 months
Exclusion Criteria:
- Advised by physician not to participate in physical activity
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Physical functional literacy
5 week physical literacy program for adults with multiple chronic conditions
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A 5 week physical literacy for program focused on virtual knowledge translation strategies to improve function and mobility for adults with multiple chronic conditions.
This is a population -based approach to rehabilitation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical Function at Baseline (Week 1)
Time Frame: Week 1
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The Patient Specific Functional Scale is a patient-reported questionnaire that asks participants to identify up to 5 important activities they are having difficulty with because of their health problem, and to rate their ability to perform those activities on a scale of 0 (unable to perform the activity) to 10 (able to perform the activity like they always have).
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Week 1
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Change in Physical Function from Week 1
Time Frame: Week 5
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The Patient Specific Functional Scale is a patient-reported questionnaire that asks participants to identify up to 5 important activities they are having difficulty with because of their health problem, and to rate their ability to perform those activities on a scale of 0 (unable to perform the activity) to 10 (able to perform the activity like they always have).
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Week 5
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Mobility Survey at Baseline (Week 1)
Time Frame: Week 1
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Manty Preclinical Disability Scale: Patient report questionnaire has been created from the work by Many (2007).
Self reported mobility is determined by asking participants to rate their ability to walk 2.0 km, walk 0.5 km 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.
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Week 1
|
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Change in Mobility from Week 1
Time Frame: Week 5
|
Manty Preclinical Disability Scale: Patient report questionnaire has been created from the work by Many (2007).
Self reported mobility is determined by asking participants to rate their ability to walk 2.0 km, walk 0.5 km 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.
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Week 5
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Self-regulation at Baseline (Week 1)
Time Frame: Week 1
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The Health education impact questionnaire (heiQ): A Patient report questionnaire that aims to evaluate eight self-management skills in people with chronic conditions.
Consists of 35 items across 7 independent constructs: health-directed activity; positive and active engagement in life; emotional wellbeing; self-monitoring and insight; constructive attitudes and approaches; skill and technique acquisition; social integration and support.
Each construct comprises an independent questionnaire.
Each construct-specific questionnaire includes 4-6 items rated on a 4-point scale (1 = strongly disagree, 2 = disagree, 3 = agree, 4 = strongly agree).
The sum of scores for all items is divided by the number of items; construct scores range between 1 and 4. A higher score indicates better self-management, with the exception of the emotional wellbeing construct for which a lower score means better emotional well being.
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Week 1
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Change in Self-regulation from Week 1
Time Frame: Week 5
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The Health education impact questionnaire (heiQ): A Patient report questionnaire that aims to evaluate eight self-management skills in people with chronic conditions.
Consists of 35 items across 7 independent constructs: health-directed activity; positive and active engagement in life; emotional wellbeing; self-monitoring and insight; constructive attitudes and approaches; skill and technique acquisition; social integration and support.
Each construct comprises an independent questionnaire.
Each construct-specific questionnaire includes 4-6 items rated on a 4-point scale (1 = strongly disagree, 2 = disagree, 3 = agree, 4 = strongly agree).
The sum of scores for all items is divided by the number of items; construct scores range between 1 and 4. A higher score indicates better self-management, with the exception of the emotional wellbeing construct for which a lower score means better emotional well being.
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Week 5
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Physical Activity at Baseline (Week 1)
Time Frame: Week 1
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International Physical Activity Questionnaire (IPAQ) Long From: The IPAQ is a 27-item self report questionnaire that measures physical activity for adults between the ages of 15 and 69 years. The questionnaire looks at the types of activities, the intensity of physical activity and sitting time that people do as part of their daily lives. This is used to estimate total physical activity in MET-min/week and time spent sitting. There are 5 domains of physical activity within the long version of the IPAQ (job related, transportation, house work/house maintenance/caring for family, recreation/sport/leisure time and time spent sitting. Participants are scored as either Low (lowest level of physical activity), Moderate or High physical activity |
Week 1
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Change in Physical Activity from week 1
Time Frame: Week 5
|
International Physical Activity Questionnaire (IPAQ) Long From: The IPAQ is a 27-item self report questionnaire that measures physical activity for adults between the ages of 15 and 69 years. The questionnaire looks at the types of activities, the intensity of physical activity and sitting time that people do as part of their daily lives. This is used to estimate total physical activity in MET-min/week and time spent sitting. There are 5 domains of physical activity within the long version of the IPAQ (job related, transportation, house work/house maintenance/caring for family, recreation/sport/leisure time and time spent sitting. Participants are scored as either Low (lowest level of physical activity), Moderate or High physical activity |
Week 5
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Self-efficacy to manage chronic conditions at Baseline (Week 1)
Time Frame: Week 1
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A 10-point self-efficacy scale to determine participant's confidence in managing their chronic conditions.
Participants will be asked to rate how confident they are with self-managing their chronic conditions on a daily basis using a single question on a scale of 1 - 10. Higher values equal greater self-efficacy.
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Week 1
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Change in Self-efficacy from week 1
Time Frame: Week 5
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A 10-point self-efficacy scale to determine participant's confidence in managing their chronic conditions.
Participants will be asked to rate how confident they are with self-managing their chronic conditions on a daily basis using a single question on a scale of 1 - 10. Higher values equal greater self-efficacy.
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Week 5
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Knowledge and Awareness of health changes that occur with aging Baseline (Week 1)
Time Frame: Week 1
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Participants will be asked to answer 2 open-ended questions related to changes that occur with mobility and physical function with aging.
Question 1: Name changes that occur with aging and chronic conditions that affect one's ability to move and get around with ease.
Question 2: Name things you can do to improve your health and ability to move around despite living with chronic conditions.
Higher scores will be based on the higher number of correct answers.
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Week 1
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Change in Awareness level from week 1
Time Frame: Week 5
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Participants will be asked to answer 2 open-ended questions related to changes that occur with mobility and physical function with aging.
Question 1: Name changes that occur with aging and chronic conditions that affect one's ability to move and get around with ease.
Question 2: Name things you can do to improve your health and ability to move around despite living with chronic conditions.
Higher scores will be based on the higher number of correct answers.
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Week 5
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Participant satisfaction of the Physical Literacy program
Time Frame: Week 5
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Participants will be asked to rate their satisfaction of the physical literacy program at the end of the 5 week study period.
They will be asked "Overall on a scale of 0 - 10 how would you rate your experience with the physical literacy program?"
Higher numbers will equate to a higher satisfaction score.
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Week 5
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Julie Richardson, PhD, McMaster University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- McMaster University
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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