Older Adults Clinical Trial
— EM-HEARTOfficial title:
Early Mobilization in Older Adults With Acute Cardiovascular Disease: A Prospective, Multi-centre Stepped Wedge Cluster Randomized Trial
Verified date | March 2023 |
Source | Lady Davis Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The EM-HEART study is a prospective, multi-centre stepped wedge cluster randomized trial to evaluate the effectiveness of a pragmatic early mobilization (EM) program to improve patient-centred and clinical outcomes in older adults with acute CV disease. There will be 256 participants ≥60 years old with acute CV disease enrolled at 6 participating Canadian hospitals. The study will investigate whether EM improves functional status during admission, as compared to usual care, and whether this leads to improved health-related quality of life post-hospitalization. Functional status will be measured with the validated Level of Function Mobility Scale. The primary outcome will be the Short-Form SF-36 physical component scale score at 1-month post-hospitalization. Secondary outcomes include functional status and hospital readmission at 1-month post-hospitalization.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | March 2024 |
Est. primary completion date | March 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility | Inclusion Criteria: - age = 60 years - no planned cardiac surgery during admission Exclusion Criteria: - projected cardiac ICU stays less than 24 hours - patients unable to complete follow-up |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Lady Davis Institute |
Semsar-Kazerooni K, Dima D, Valiquette J, Berube-Dufour J, Goldfarb M. Early Mobilization in People With Acute Cardiovascular Disease. Can J Cardiol. 2021 Feb;37(2):232-240. doi: 10.1016/j.cjca.2020.03.038. Epub 2020 Apr 2. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Short Form (SF)-36 Physical Component Summary (PCS) score at 1-month post-hospitalization | Health-related quality of life | 1 month post-hospitalization | |
Secondary | SF-36 Physical Component Scale score | Health-related quality of life | 12 months post-hospitalization | |
Secondary | SF-36 Mental Component Summary score | Health-related quality of life | 1 month post-hospitalization | |
Secondary | SF-36 Mental Component Summary score | Health-related quality of life | 12 months post-hospitalization | |
Secondary | Level of Function Mobility Score | Functional status | 1 month post-hospitalization | |
Secondary | Level of Function Mobility Score | Functional status | 12 months post-hospitalization | |
Secondary | Hospital readmission | Resource use outcome | 1 month post-hospitalization | |
Secondary | Hospital readmission | Resource use outcome | 12 months post-hospitalization |
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