Early Mobilization in Older Adults With Acute Cardiovascular Disease

NCT04593602 | Withdrawn Phase 3 DMC

• 1 other identifier: Lady Davis Institute
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Early Mobilization; Older Adults; Acute Cardiovascular Disease; Nursing

Outcome Measures

Primary Outcomes (1)

• Short Form (SF)-36 Physical Component Summary (PCS) score at 1-month post-hospitalization

  Health-related quality of life

  1 month post-hospitalization

Secondary Outcomes (7)

• SF-36 Physical Component Scale score

  12 months post-hospitalization

• SF-36 Mental Component Summary score

  1 month post-hospitalization

• SF-36 Mental Component Summary score

  12 months post-hospitalization

• Level of Function Mobility Score

  1 month post-hospitalization

• Level of Function Mobility Score

  12 months post-hospitalization

Study Arms (2)

Early Mobilization Intervention

EXPERIMENTAL

The bedside nurse determines the prehospital Level of Function based on patient and family report and current Level of Function based on nursing mobility assessment. Each Level of Function has 3 primary activities designed to promote the patient to the next level. The nurse leads mobility activities based on the patient's current Level of Function once per shift, twice daily (AM+PM). If a patient is able to complete each of the 3 activities, the nurse on the subsequent shift will assess whether the Level of Function can be advanced. Physiotherapy consultation is available if required, although not obligatory. Patients are encouraged to spend as much time in the chair and ambulatory as possible.

Behavioral: Early Mobilization

Usual Mobility Care

ACTIVE COMPARATOR

Usual mobility care involves following physician orders for mobilization (i.e., bedrest, mobilization to chair with meals, physiotherapy consultation and care) as per local practice.

Behavioral: Usual Mobility Care

Interventions

Early Mobilization BEHAVIORAL

Nurse-driven early mobilization activities twice daily

Early Mobilization Intervention

Usual Mobility Care BEHAVIORAL

Usual mobility care involves following physician orders for mobilization (i.e., bedrest, mobilization to chair with meals, physiotherapy consultation and care) as per local practice.

Usual Mobility Care

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 60 years
• no planned cardiac surgery during admission

You may not qualify if:

• projected cardiac ICU stays less than 24 hours
• patients unable to complete follow-up

Sponsors & Collaborators

• Lady Davis Institute: lead

Related Publications (1)

• 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.

  PMID: 32739452 RESULT

MeSH Terms

Interventions

Early Ambulation

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician-Investigator

Model Details: In the stepped-wedge cluster design, there is random and sequential crossover of clusters from control (phase 1) to intervention (phase 2) until all clusters are exposed. The nature of the intervention requires randomization of entire units to the intervention with associated mobility culture change and this precludes a standard randomized controlled trial design (i.e., randomization of some patients to the intervention but not others). The stepped-wedge design allows each site to function as its own control.

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 20, 2020
• Study Start: April 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: March 10, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share