Self-management of Chronic Mobility Limitations in MUHC Seniors
Primary Purpose
Seniors With Mobility Limitations
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Mobility self-management with Mentor
Mobility self-management with guidebook
Sponsored by
About this trial
This is an interventional treatment trial for Seniors With Mobility Limitations focused on measuring Elderly, mobility limitations, self-management, exercise
Eligibility Criteria
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Lachine Hospital
- Montreal General Hospital
- Royal Victoria Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mentor
Guidebook
Arm Description
Outcomes
Primary Outcome Measures
Brief Pain Questionnaire
DASH
LEFS
RAND-MOS36
Short Self Efficacy scale
Secondary Outcome Measures
Health care utilization
Medication management
Full Information
NCT ID
NCT01593345
First Posted
May 3, 2012
Last Updated
December 18, 2015
Sponsor
McGill University
Collaborators
Richard and Edith Strauss Foundation of Canada
1. Study Identification
Unique Protocol Identification Number
NCT01593345
Brief Title
Self-management of Chronic Mobility Limitations in MUHC Seniors
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University
Collaborators
Richard and Edith Strauss Foundation of Canada
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seniors With Mobility Limitations
Keywords
Elderly, mobility limitations, self-management, exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mentor
Arm Type
Experimental
Arm Title
Guidebook
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Mobility self-management with Mentor
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Mobility self-management with guidebook
Intervention Description
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.
Primary Outcome Measure Information:
Title
Brief Pain Questionnaire
Time Frame
2 time points (baseline and 6 months)
Title
DASH
Time Frame
2 time points (baseline and 6 months)
Title
LEFS
Time Frame
2 time points (baseline and 6 months)
Title
RAND-MOS36
Time Frame
2 time points (baseline and 6 months)
Title
Short Self Efficacy scale
Time Frame
2 time points (baseline and 6 months)
Secondary Outcome Measure Information:
Title
Health care utilization
Time Frame
2 time points (baseline and 6 months)
Title
Medication management
Time Frame
2 time points (baseline and 6 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy E Mayo, PhD
Organizational Affiliation
McGill University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lachine Hospital
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Montreal General Hospital
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Royal Victoria Hospital
City
Montreal
State/Province
Quebec
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
9708876
Citation
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.
Results Reference
background
PubMed Identifier
21532763
Citation
Passalent 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.
Results Reference
background
PubMed Identifier
15574526
Citation
Marks 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.
Results Reference
background
PubMed Identifier
15855284
Citation
Marks 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.
Results Reference
background
PubMed Identifier
19115992
Citation
Daniels 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.
Results Reference
background
PubMed Identifier
21233306
Citation
Fritz 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.
Results Reference
background
PubMed Identifier
16557505
Citation
Graham 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.
Results Reference
background
PubMed Identifier
10620960
Citation
Wagner 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.
Results Reference
background
PubMed Identifier
11816692
Citation
Wagner 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.
Results Reference
background
PubMed Identifier
16172441
Citation
Chodosh 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.
Results Reference
background
PubMed Identifier
17325405
Citation
Kennedy 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.
Results Reference
background
PubMed Identifier
17991978
Citation
Kennedy 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.
Results Reference
background
PubMed Identifier
10737689
Citation
King 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.
Results Reference
background
PubMed Identifier
10647968
Citation
Lazowski 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.
Results Reference
background
PubMed Identifier
16778001
Citation
Kramer 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.
Results Reference
background
Links:
URL
https://secure.cihi.ca/estore/productFamily.htm?locale=en&pf=PFC1677
Description
Health Care in Canada, 2011:A Focus on Seniors and Aging.
URL
http://www.statcan.gc.ca/pub/89-519-x/89-519-x2006001-eng.pdf
Description
Portrait of Seniors in Canada.
URL
http://www.statcan.gc.ca/pub/89-519-x/2006001/t/4181621-eng.htm
Description
Percentage of persons who are active, moderately active or inactive, by age group.
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Self-management of Chronic Mobility Limitations in MUHC Seniors
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