Seniors With Mobility LimitationsNCT01593345
Self-management of Chronic Mobility Limitations in MUHC Seniors
A study testing Mobility self-management with Mentor and Mobility self-management with guidebook in people with Seniors With Mobility Limitations, run by McGill University at 3 sites in Canada.
Trial summary
The population is aging and chronic conditions, which are major causes of pain and mobility limitations, are on the rise, however, current access to physiotherapy is difficult. Knowledge on managing disability is substantial, but methods to translate into action are lacking. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Seniors With Mobility Limitations
- What is being tested?
- Mobility self-management with Mentor and Mobility self-management with guidebook
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesCanada
- Study dates
- Feb 2013to Dec 2015
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- community dwelling seniors,
- aged 70 years and older,
- recently discharged from one of the adult general (MGH, RVH, Lachine) hospital sites,
- with anyone of the following mobility limitations:
- Limitation in walking more than 1 block
- Limitation in going up 1 flight of stairs
Show all 11Show fewer
- Unable to get groceries without help
- Unable to do housework (dishes, meals, vacuuming, making bed) without help
- Self-rated health fair or poor
- Pain
- Shortness of breath
Who cannot join
- seniors discharged with orthopaedic or cardiac surgery, or
- with stroke or myocardial infarction, as formal rehabilitation is part of the usual care plan for these conditions.
- Also excluded will be people with dementia as identified on the medical chart.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Lachine Hospital
Montreal, Quebec
Montreal General Hospital
Montreal, Quebec
Royal Victoria Hospital
Montreal, Quebec
About this study
Official title: Promotion of Self-management of Chronic Mobility Limitations Among Vulnerable Seniors at the MUHC: Training the New Generation of Canadian Physiotherapists for This Role. Addendum: Planning Physiotherapy Services for Persons Treated at the MUHC for Cancer: A Needs Assessment
The population is aging and chronic conditions, which are major causes of pain and mobility limitations, are on the rise, however, current access to physiotherapy is difficult. Knowledge on managing disability is substantial, but methods to translate into action are lacking. This project is designed to test a novel method of promoting function in vulnerable seniors and simultaneously develop awareness in the new generation of physiotherapists that they can have a proactive role in health promotion. The investigators are proposing a pilot project targeting both students and patients.
The research question are (1) What are the needs of vulnerable patients at the MUHC? Two groups will be targeted; newly discharged seniors (who will be eligible for an intervention) and cancer outpatients who will be surveyed only);(2) For a senior population at risk for physical deterioration, to what extent is a personalized mentoring approach to optimizing function and preventing disability through developing self-management skills more effective in improving outcomes than the provision of written material covering the same general content? (3) Does a mentoring experience with vulnerable seniors through development and teaching of a self-management program (comprised of education and support) produce meaningful positive changes in future clinicians' knowledge, skills and attitude towards modes of delivering physiotherapy services and promoting self-management in Canadian seniors?
Read more
There are two phases to this study: a survey and randomized controlled trial (RCT). The survey phase will identify mobility needs of two groups, newly discharged seniors and cancer outpatients. The needs assessment for newly discharged seniors will identify people eligible for the (RCT) component; the needs assessment for cancer outpatients will inform the development of interventions for this specific group. The RCT component will be piloted for recently discharged community dwelling seniors 70 years and older only.
A sample of 400 seniors recently discharged from the adult, general, hospital sites of the MUHC will be contacted for a needs assessment. From this pool, the investigators anticipate 100 will be eligible and 60 will be randomized, 30 to the mentor intervention and 30 to the control group. Participants will be followed-up for 6 months and assessments will be performed at 2 time points (baseline and 6 months). The main outcome is a standardized response ratio (SRR) estimated across all persons and measures. SRRs will be calculated for three groups of response variables: impairment/mobility measures, quality of life indicators, and health services outcomes.
In parallel, to determine cancer survivor needs, the investigators will contact 600 cancer survivors; as the investigators anticipate 400 will answer the survey. The analysis of this survey will consist of frequency of specific needs by diagnosis and treatment.
- Conditions
- Seniors With Mobility Limitations
- Being tested
- Mobility self-management with Mentor, Mobility self-management with guidebook
- Keywords
- Elderly, mobility limitations, self-management, exercise
- Medical subject headings
- Mobility Limitation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobility self-management with MentorOther
will be offered an evaluation and treatment plan supervised by a qualified physiotherapist, accompanied by written and visual material to enhance mobility self-management skills, supported by telephone mentoring by physiotherapy students in the Professional Master's program. The components of the mobility self-management program will target skill enhancement of each senior to identify their functional limitations, set realistic goals for mobility improvement, develop a mobility action plan, carry out the plan, and then re-assess their function and mobility. Mobility self-assessment, personalized goals, and the action plan will be incorporated into a personalized workbook that the senior can use to monitor their function profile and serve as a communication aid during health care encounters.
Mobility self-management with guidebookOther
will be mailed an exercise guide targeting the key mobility limitations common in the elderly (range of motion, arm, leg, and core strength, and breathing). This guide has been developed and has been pilot tested on a small number of seniors and has been shown to be acceptable and feasible.
| Study group | Role | What they receive |
|---|---|---|
| Mentor | Experimental | Not described Receives: Other: Mobility self-management with Mentor |
| Guidebook | Active comparator | Not described Receives: Other: Mobility self-management with guidebook |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Pain Questionnaire
Measured: 2 time points (baseline and 6 months)
DASH
Measured: 2 time points (baseline and 6 months)
LEFS
Measured: 2 time points (baseline and 6 months)
RAND-MOS36
Measured: 2 time points (baseline and 6 months)
Short Self Efficacy scale
Measured: 2 time points (baseline and 6 months)
Secondary outcomes (2)
Health care utilization
Measured: 2 time points (baseline and 6 months)
Medication management
Measured: 2 time points (baseline and 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2012 (estimated)
- Study startFeb 2013
- Primary completionJan 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Seniors With Mobility LimitationsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- Richard and Edith Strauss Foundation of Canada
- Responsible party
- Principal investigator, Nancy Mayo, McGill University
- Investigators
- Nancy E Mayo, PhD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01593345
- Sponsor's protocol ID
- 2476
- Status last verified
- Dec 2015
- First submitted
- 3 May 2012
- Last updated
- 21 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Raina P, Dukeshire S, Lindsay J, Chambers LW. Chronic conditions and disabilities among seniors: an analysis of population-based health and activity limitation surveys. Ann Epidemiol. 1998 Aug;8(6):402-9. doi: 10.1016/s1047-2797(98)00006-4.
PubMed 9708876Passalent LA, Landry MD, Cott CA. Exploring wait list prioritization and management strategies for publicly funded ambulatory rehabilitation services in ontario, Canada: further evidence of barriers to access for people with chronic disease. Healthc Policy. 2010 May;5(4):e139-56.
PubMed 21532763Marks R, Allegrante JP, Lorig K. A review and synthesis of research evidence for self-efficacy-enhancing interventions for reducing chronic disability: implications for health education practice (part I). Health Promot Pract. 2005 Jan;6(1):37-43. doi: 10.1177/1524839904266790.
PubMed 15574526Marks R, Allegrante JP, Lorig K. A review and synthesis of research evidence for self-efficacy-enhancing interventions for reducing chronic disability: implications for health education practice (part II). Health Promot Pract. 2005 Apr;6(2):148-56. doi: 10.1177/1524839904266792.
PubMed 15855284Daniels R, van Rossum E, de Witte L, Kempen GI, van den Heuvel W. Interventions to prevent disability in frail community-dwelling elderly: a systematic review. BMC Health Serv Res. 2008 Dec 30;8:278. doi: 10.1186/1472-6963-8-278.
PubMed 19115992Fritz JM, Hunter SJ, Tracy DM, Brennan GP. Utilization and clinical outcomes of outpatient physical therapy for medicare beneficiaries with musculoskeletal conditions. Phys Ther. 2011 Mar;91(3):330-45. doi: 10.2522/ptj.20090290. Epub 2011 Jan 13.
PubMed 21233306Graham ID, Logan J, Harrison MB, Straus SE, Tetroe J, Caswell W, Robinson N. Lost in knowledge translation: time for a map? J Contin Educ Health Prof. 2006 Winter;26(1):13-24. doi: 10.1002/chp.47.
PubMed 16557505Wagner EH, Davis C, Schaefer J, Von Korff M, Austin B. A survey of leading chronic disease management programs: are they consistent with the literature? Manag Care Q. 1999 Summer;7(3):56-66.
PubMed 10620960Wagner EH, Austin BT, Davis C, Hindmarsh M, Schaefer J, Bonomi A. Improving chronic illness care: translating evidence into action. Health Aff (Millwood). 2001 Nov-Dec;20(6):64-78. doi: 10.1377/hlthaff.20.6.64.
PubMed 11816692Chodosh J, Morton SC, Mojica W, Maglione M, Suttorp MJ, Hilton L, Rhodes S, Shekelle P. Meta-analysis: chronic disease self-management programs for older adults. Ann Intern Med. 2005 Sep 20;143(6):427-38. doi: 10.7326/0003-4819-143-6-200509200-00007.
PubMed 16172441Kennedy A, Reeves D, Bower P, Lee V, Middleton E, Richardson G, Gardner C, Gately C, Rogers A. The effectiveness and cost effectiveness of a national lay-led self care support programme for patients with long-term conditions: a pragmatic randomised controlled trial. J Epidemiol Community Health. 2007 Mar;61(3):254-61. doi: 10.1136/jech.2006.053538.
PubMed 17325405Kennedy A, Rogers A, Bower P. Support for self care for patients with chronic disease. BMJ. 2007 Nov 10;335(7627):968-70. doi: 10.1136/bmj.39372.540903.94.
PubMed 17991978King AC, Pruitt LA, Phillips W, Oka R, Rodenburg A, Haskell WL. Comparative effects of two physical activity programs on measured and perceived physical functioning and other health-related quality of life outcomes in older adults. J Gerontol A Biol Sci Med Sci. 2000 Feb;55(2):M74-83. doi: 10.1093/gerona/55.2.m74.
PubMed 10737689Lazowski DA, Ecclestone NA, Myers AM, Paterson DH, Tudor-Locke C, Fitzgerald C, Jones G, Shima N, Cunningham DA. A randomized outcome evaluation of group exercise programs in long-term care institutions. J Gerontol A Biol Sci Med Sci. 1999 Dec;54(12):M621-8. doi: 10.1093/gerona/54.12.m621.
PubMed 10647968Kramer AF, Erickson KI, Colcombe SJ. Exercise, cognition, and the aging brain. J Appl Physiol (1985). 2006 Oct;101(4):1237-42. doi: 10.1152/japplphysiol.00500.2006. Epub 2006 Jun 15.
PubMed 16778001
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promotion of Self-management of Chronic Mobility Limitations Among Vulnerable Seniors at the MUHC: Training the New Generation of Canadian Physiotherapists for This Role. Addendum: Planning Physiotherapy Services for Persons Treated at the MUHC for Cancer: A Needs Assessment
- ClinicalTrials.gov ID
- NCT01593345
- Acronym / sponsor ID
- 2476
- Conditions
- Seniors With Mobility Limitations
- Keywords
- Elderly, mobility limitations, self-management, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- Richard and Edith Strauss Foundation of Canada
- Study start
- Feb 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 8 May 2012 (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 population is aging and chronic conditions, which are major causes of pain and mobility limitations, are on the rise, however, current access to physiotherapy is difficult. Knowledge on managing disability is substantial, but methods to translate into action are lacking. This project is designed to test a novel method of promoting function in vulnerable seniors and simultaneously develop awareness in the new generation of physiotherapists that they can have a proactive role in health promotion. The investigators are proposing a pilot project targeting both students and patients.
The research question are (1) What are the needs of vulnerable patients at the MUHC? Two groups will be targeted; newly discharged seniors (who will be eligible for an intervention) and cancer outpatients who will be surveyed only);(2) For a senior population at risk for physical deterioration, to what extent is a personalized mentoring approach to optimizing function and preventing disability through developing self-management skills more effective in improving outcomes than the provision of written material covering the same general content? (3) Does a mentoring experience with vulnerable seniors through development and teaching of a self-management program (comprised of education and support) produce meaningful positive changes in future clinicians' knowledge, skills and attitude towards modes of delivering physiotherapy services and promoting self-management in Canadian seniors?
There are two phases to this study: a survey and randomized controlled trial (RCT). The survey phase will identify mobility needs of two groups, newly discharged seniors and cancer outpatients. The needs assessment for newly discharged seniors will identify people eligible for the (RCT) component; the needs assessment for cancer outpatients will inform the development of interventions for this specific group. The RCT component will be piloted for recently discharged community dwelling seniors 70 years and older only.
A sample of 400 seniors recently discharged from the adult, general, hospital sites of the MUHC will be contacted for a needs assessment. From this pool, the investigators anticipate 100 will be eligible and 60 will be randomized, 30 to the mentor intervention and 30 to the control group. Participants will be followed-up for 6 months and assessments will be performed at 2 time points (baseline and 6 months). The main outcome is a standardized response ratio (SRR) estimated across all persons and measures. SRRs will be calculated for three groups of response variables: impairment/mobility measures, quality of life indicators, and health services outcomes.
In parallel, to determine cancer survivor needs, the investigators will contact 600 cancer survivors; as the investigators anticipate 400 will answer the survey. The analysis of this survey will consist of frequency of specific needs by diagnosis and treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mentor | Experimental | Other: Mobility self-management with Mentor |
| Guidebook | Active comparator | Other: Mobility self-management with guidebook |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- community dwelling seniors,
- aged 70 years and older,
- recently discharged from one of the adult general (MGH, RVH, Lachine) hospital sites,
- with anyone of the following mobility limitations:
Key exclusion criteria (3 listed)
- seniors discharged with orthopaedic or cardiac surgery, or
- with stroke or myocardial infarction, as formal rehabilitation is part of the usual care plan for these conditions.
- Also excluded will be people with dementia as identified on the medical chart.
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 |
|---|---|---|
| Mobility self-management with Mentorwill be offered an evaluation and treatment plan supervised by a qualified physiotherapist, accompanied by written and visual material to enhance mobility self-management skills, supported by telephone mentoring by physiotherapy students in the Professional Master's program. The components of the mobility self-management program will target skill enhancement of each senior to identify their functional limitations, set realistic goals for mobility improvement, develop a mobility action plan, carry out the plan, and then re-assess their function and mobility. Mobility self-assessment, personalized goals, and the action plan will be incorporated into a personalized workbook that the senior can use to monitor their function profile and serve as a communication aid during health care encounters. | Other | Mentor |
| Mobility self-management with guidebookwill be mailed an exercise guide targeting the key mobility limitations common in the elderly (range of motion, arm, leg, and core strength, and breathing). This guide has been developed and has been pilot tested on a small number of seniors and has been shown to be acceptable and feasible. | Other | Guidebook |
Primary outcome
Brief Pain Questionnaire
Time frame: 2 time points (baseline and 6 months)
DASH
Time frame: 2 time points (baseline and 6 months)
LEFS
Time frame: 2 time points (baseline and 6 months)
RAND-MOS36
Time frame: 2 time points (baseline and 6 months)
Short Self Efficacy scale
Time frame: 2 time points (baseline and 6 months)
2 secondary outcomes
Health care utilization
Time frame: 2 time points (baseline and 6 months)
Medication management
Time frame: 2 time points (baseline and 6 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 21 Dec 2015.
- Background: PubMed 9708876Raina P, Dukeshire S, Lindsay J, Chambers LW. Chronic conditions and disabilities among seniors: an analysis of population-based health and activity limitation surveys. Ann Epidemiol. 1998 Aug;8(6):402-9. doi: 10.1016/s1047-2797(98)00006-4.
- Background: PubMed 21532763Passalent LA, Landry MD, Cott CA. Exploring wait list prioritization and management strategies for publicly funded ambulatory rehabilitation services in ontario, Canada: further evidence of barriers to access for people with chronic disease. Healthc Policy. 2010 May;5(4):e139-56.
- Background: PubMed 15574526Marks R, Allegrante JP, Lorig K. A review and synthesis of research evidence for self-efficacy-enhancing interventions for reducing chronic disability: implications for health education practice (part I). Health Promot Pract. 2005 Jan;6(1):37-43. doi: 10.1177/1524839904266790.
- Background: PubMed 15855284Marks R, Allegrante JP, Lorig K. A review and synthesis of research evidence for self-efficacy-enhancing interventions for reducing chronic disability: implications for health education practice (part II). Health Promot Pract. 2005 Apr;6(2):148-56. doi: 10.1177/1524839904266792.
- Background: PubMed 19115992Daniels R, van Rossum E, de Witte L, Kempen GI, van den Heuvel W. Interventions to prevent disability in frail community-dwelling elderly: a systematic review. BMC Health Serv Res. 2008 Dec 30;8:278. doi: 10.1186/1472-6963-8-278.
- Background: PubMed 21233306Fritz JM, Hunter SJ, Tracy DM, Brennan GP. Utilization and clinical outcomes of outpatient physical therapy for medicare beneficiaries with musculoskeletal conditions. Phys Ther. 2011 Mar;91(3):330-45. doi: 10.2522/ptj.20090290. Epub 2011 Jan 13.
- Background: PubMed 16557505Graham ID, Logan J, Harrison MB, Straus SE, Tetroe J, Caswell W, Robinson N. Lost in knowledge translation: time for a map? J Contin Educ Health Prof. 2006 Winter;26(1):13-24. doi: 10.1002/chp.47.
- Background: PubMed 10620960Wagner EH, Davis C, Schaefer J, Von Korff M, Austin B. A survey of leading chronic disease management programs: are they consistent with the literature? Manag Care Q. 1999 Summer;7(3):56-66.
- Background: PubMed 11816692Wagner EH, Austin BT, Davis C, Hindmarsh M, Schaefer J, Bonomi A. Improving chronic illness care: translating evidence into action. Health Aff (Millwood). 2001 Nov-Dec;20(6):64-78. doi: 10.1377/hlthaff.20.6.64.
- Background: PubMed 16172441Chodosh J, Morton SC, Mojica W, Maglione M, Suttorp MJ, Hilton L, Rhodes S, Shekelle P. Meta-analysis: chronic disease self-management programs for older adults. Ann Intern Med. 2005 Sep 20;143(6):427-38. doi: 10.7326/0003-4819-143-6-200509200-00007.
- Background: PubMed 17325405Kennedy A, Reeves D, Bower P, Lee V, Middleton E, Richardson G, Gardner C, Gately C, Rogers A. The effectiveness and cost effectiveness of a national lay-led self care support programme for patients with long-term conditions: a pragmatic randomised controlled trial. J Epidemiol Community Health. 2007 Mar;61(3):254-61. doi: 10.1136/jech.2006.053538.
- Background: PubMed 17991978Kennedy A, Rogers A, Bower P. Support for self care for patients with chronic disease. BMJ. 2007 Nov 10;335(7627):968-70. doi: 10.1136/bmj.39372.540903.94.
- Health Care in Canada, 2011:A Focus on Seniors and Aging.Link provided by the sponsor.
- Portrait of Seniors in Canada.Link provided by the sponsor.
- Percentage of persons who are active, moderately active or inactive, by age group.Link provided by the sponsor.
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.
Nancy E Mayo, PhD principal investigator
McGill University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobility self-management with Mentor and Mobility self-management with guidebook in people with Seniors With Mobility Limitations, run by McGill University at 3 sites 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 11 inclusion and 3 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 21 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Brief Pain Questionnaire (time frame: 2 time points (baseline and 6 months)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01593345, which also lists 15 linked publications.
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 21 Dec 2015.