Seniors With Mobility Limitations Clinical Trial
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
| Verified date | December 2015 |
| Source | McGill University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: Ethics Review Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | December 2015 |
| Est. primary completion date | January 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 70 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Lachine Hospital | Montreal | Quebec |
| Canada | Montreal General Hospital | Montreal | Quebec |
| Canada | Royal Victoria Hospital | Montreal | Quebec |
| Lead Sponsor | Collaborator |
|---|---|
| McGill University | Richard and Edith Strauss Foundation of Canada |
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* Note: There are 15 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Brief Pain Questionnaire | 2 time points (baseline and 6 months) | No | |
| Primary | DASH | 2 time points (baseline and 6 months) | No | |
| Primary | LEFS | 2 time points (baseline and 6 months) | No | |
| Primary | RAND-MOS36 | 2 time points (baseline and 6 months) | No | |
| Primary | Short Self Efficacy scale | 2 time points (baseline and 6 months) | No | |
| Secondary | Health care utilization | 2 time points (baseline and 6 months) | No | |
| Secondary | Medication management | 2 time points (baseline and 6 months) | No |