Chronic Conditions, MultipleNCT04494711
Physical Literacy and Rehabilitation
A study testing Physical Functional Literacy for Adults in people with Chronic Conditions, Multiple and Aging, run by Julie Richardson at 1 site in Canada.
Trial summary
With the aging population, the prevalence of chronic conditions continues to rise, affecting 1/3 of Canadians. The promotion of physical literacy, defined as "the motivation, confidence, physical competence and knowledge, to take responsibility for engagement in physical activity for life", has emerged as a promising… Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Conditions, Multiple, Aging, Mobility Limitation
- What is being tested?
- Physical Functional Literacy for Adults
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2021to 28 Feb 2022
- Phase
- Interventional
- 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 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Advised by physician not to participate in physical activity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-phased Technology Integrated Physical Literacy Program Targeting Adults With Multimorbidity. A Knowledge Translation Project
With the aging population, the prevalence of chronic conditions continues to rise, affecting 1/3 of Canadians. The promotion of physical literacy, defined as "the motivation, confidence, physical competence and knowledge, to take responsibility for engagement in physical activity for life", has emerged as a promising strategy to increase movement for children. However, little is known about how physical literacy can impact aging adults. A working definition of physical literacy for adults focusing on mobility, function and self-monitoring provides opportunity to guide public health programs in addressing the rehabilitation needs of persons living with multiple chronic conditions.
Read the 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.
- Conditions
- Chronic Conditions, Multiple, Aging, Mobility Limitation
- Being tested
- Physical Functional Literacy for Adults
- Keywords
- Adults, physical function, physical literacy
- Medical subject headings
- Multiple Chronic Conditions, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Functional Literacy for AdultsBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Physical functional literacy | Experimental | 5 week physical literacy program for adults with multiple chronic conditions Receives: Behavioral: Physical Functional Literacy for Adults |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Function at Baseline (Week 1)
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).
Measured: Week 1
Change in Physical Function from Week 1
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).
Measured: Week 5
Mobility Survey at Baseline (Week 1)
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.
Measured: Week 1
Change in Mobility from Week 1
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.
Measured: Week 5
Self-regulation at Baseline (Week 1)
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.
Measured: Week 1
Change in Self-regulation from Week 1
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.
Measured: Week 5
Secondary outcomes (7)
Physical Activity at Baseline (Week 1)
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
Measured: Week 1
Change in Physical Activity from week 1
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
Measured: Week 5
Self-efficacy to manage chronic conditions at Baseline (Week 1)
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.
Measured: Week 1
Change in Self-efficacy from week 1
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.
Measured: Week 5
Knowledge and Awareness of health changes that occur with aging Baseline (Week 1)
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.
Measured: Week 1
Change in Awareness level from week 1
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.
Measured: Week 5
Participant satisfaction of the Physical Literacy program
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.
Measured: Week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start1 Jan 2021
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Conditions, MultipleStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Mixed Methods
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Julie Richardson
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University
- Responsible party
- Sponsor-investigator, Julie Richardson, McMaster University
- Investigators
- Julie Richardson, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04494711
- Sponsor's protocol ID
- McMaster University
- Status last verified
- May 2023
- First submitted
- 28 Jul 2020
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-phased Technology Integrated Physical Literacy Program Targeting Adults With Multimorbidity. A Knowledge Translation Project
- ClinicalTrials.gov ID
- NCT04494711
- Acronym / sponsor ID
- McMaster University
- Conditions
- Chronic Conditions, Multiple, Aging, Mobility Limitation
- Keywords
- Adults, physical function, physical literacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Julie RichardsonUniversity, hospital or other
- Collaborators
- McMaster University
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 31 Jul 2020 (actual)
- 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.
With the aging population, the prevalence of chronic conditions continues to rise, affecting 1/3 of Canadians. The promotion of physical literacy, defined as "the motivation, confidence, physical competence and knowledge, to take responsibility for engagement in physical activity for life", has emerged as a promising strategy to increase movement for children. However, little is known about how physical literacy can impact aging adults. A working definition of physical literacy for adults focusing on mobility, function and self-monitoring provides opportunity to guide public health programs in addressing the rehabilitation needs of persons living with multiple chronic conditions.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Mixed Methods
| Arm | Type | Receives |
|---|---|---|
| Physical functional literacy | Experimental | Behavioral: Physical Functional Literacy for Adults5 week physical literacy program for adults with multiple chronic conditions |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects will be screened by the primary researcher for the following inclusion criteria:
Key exclusion criteria (1 listed)
- Advised by physician not to participate in physical activity
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 |
|---|---|---|
| Physical Functional Literacy for AdultsA 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 | Behavioural | Physical functional literacy |
Primary outcome
Physical Function at Baseline (Week 1)
Time frame: Week 1
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).
Change in Physical Function from Week 1
Time frame: Week 5
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).
Mobility Survey at Baseline (Week 1)
Time frame: Week 1
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.
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.
Self-regulation at Baseline (Week 1)
Time frame: Week 1
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.
Change in Self-regulation from Week 1
Time frame: Week 5
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.
7 secondary outcomes
Physical Activity at Baseline (Week 1)
Time frame: Week 1
Change in Physical Activity from week 1
Time frame: Week 5
Self-efficacy to manage chronic conditions at Baseline (Week 1)
Time frame: Week 1
Change in Self-efficacy from week 1
Time frame: Week 5
Knowledge and Awareness of health changes that occur with aging Baseline (Week 1)
Time frame: Week 1
Change in Awareness level from week 1
Time frame: Week 5
Participant satisfaction of the Physical Literacy program
Time frame: Week 5
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 11 May 2023.
- Individual participant dataSharing planned: No
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Functional Literacy for Adults in people with Chronic Conditions, Multiple and Aging, run by Julie Richardson 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 1 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 11 May 2023. 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 Function at Baseline (Week 1) (time frame: Week 1). The study lists 6 primary outcomes in all. 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 11 May 2023.