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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
McGill University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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:

    1. Limitation in walking more than 1 block
    2. Limitation in going up 1 flight of stairs
    3. Unable to get groceries without help
    4. Unable to do housework (dishes, meals, vacuuming, making bed) without help
    5. Self-rated health fair or poor
    6. Pain
    7. 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

First Posted
May 3, 2012
Last Updated
December 18, 2015
Sponsor
McGill University
Collaborators
Richard and Edith Strauss Foundation of Canada
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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

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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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