Self-management of Chronic Mobility Limitations in MUHC Seniors

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by McGill University
Sponsor:
Collaborator:
Richard and Edith Strauss Foundation of Canada
Information provided by (Responsible Party):
Nancy Mayo, McGill University
ClinicalTrials.gov Identifier:
NCT01593345
First received: May 3, 2012
Last updated: February 20, 2013
Last verified: February 2013
  Purpose

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 estimated across all persons and measures. 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.


Condition Intervention
Seniors With Mobility Limitations
Other: Mobility self-management with Mentor
Other: Mobility self-management with guidebook

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by McGill University:

Primary Outcome Measures:
  • Brief Pain Questionnaire [ Time Frame: 2 time points (baseline and 6 months) ] [ Designated as safety issue: No ]
  • DASH [ Time Frame: 2 time points (baseline and 6 months) ] [ Designated as safety issue: No ]
  • LEFS [ Time Frame: 2 time points (baseline and 6 months) ] [ Designated as safety issue: No ]
  • RAND-MOS36 [ Time Frame: 2 time points (baseline and 6 months) ] [ Designated as safety issue: No ]
  • Short Self Efficacy scale [ Time Frame: 2 time points (baseline and 6 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health care utilization [ Time Frame: 2 time points (baseline and 6 months) ] [ Designated as safety issue: No ]
  • Medication management [ Time Frame: 2 time points (baseline and 6 months) ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: February 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mentor Other: Mobility self-management with Mentor
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.
Active Comparator: Guidebook Other: Mobility self-management with guidebook
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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

    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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01593345

Contacts
Contact: Sabrina M Figueiredo, PhD student 514-934-1934 ext 36926 sabrina.figueiredo@mail.mcgill.ca

Locations
Canada, Quebec
Royal Victoria Hospital Recruiting
Montreal, Quebec, Canada
Contact: Sabrina Figueiredo, PhD student    514-934-1934 ext 36926    sabrina.figueiredo@mail.mcgill.ca   
Principal Investigator: Nancy E Mayo, PhD         
Montreal General Hospital Recruiting
Montreal, Quebec, Canada
Contact: Sabrina Figueiredo, PhD student    514-934-1934 ext 36926    sabrina.figueiredo@mail.mcgill.ca   
Principal Investigator: Nancy E Mayo, PhD         
Lachine Hospital Not yet recruiting
Montreal, Quebec, Canada
Contact: Sabrina M Figueiredo, PhD student    514-934-1934 ext 36926    sabrina.figueiredo@mail.mcgill.ca   
Principal Investigator: Nancy E Mayo, PhD         
Sponsors and Collaborators
McGill University
Richard and Edith Strauss Foundation of Canada
Investigators
Principal Investigator: Nancy E Mayo, PhD McGill University
  More Information

Additional Information:
Publications:

Responsible Party: Nancy Mayo, Dr, McGill University
ClinicalTrials.gov Identifier: NCT01593345     History of Changes
Other Study ID Numbers: 2476
Study First Received: May 3, 2012
Last Updated: February 20, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by McGill University:
Elderly
mobility limitations
self-management
exercise

Additional relevant MeSH terms:
Mobility Limitation
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014