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Cardiovascular DiseasesNCT06393829

Early Mobilization in Cardiovascular Units

A study testing Applying the Early Mobilization Program in people with Cardiovascular Diseases, run by Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Insufficient mobility contributes to functional decline in hospitalized cardiac patients. Early mobilization programs were shown to improve functional status, increase the likelihood of home discharges, and reduce the length of stay [1]. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiovascular Diseases
What is being tested?
Applying the Early Mobilization Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
350 participants
Where
1 siteCanada
Study dates
1 Jun 2024to 1 Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All healthcare professionals working in the cardiovascular unit at the Jewish General Hospital.
  • All patients admitted to the cardiovascular unit at the Jewish General Hospital.

Who cannot join

  • Patients who don't speak English or French.

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal/Centre de rech interdisciplinaire en réadaptation du Montréal métropolitain

    Montreal, Quebec, H3S 1M9

    514 340-2085 ext. 144778, administration.crir@ssss.gouv.qc.ca

Other trials in Canada

About this study

Official title: Implementation of an Early Mobilization Program in Cardiovascular Units

Insufficient mobility contributes to functional decline in hospitalized cardiac patients. Early mobilization programs were shown to improve functional status, increase the likelihood of home discharges, and reduce the length of stay [1]. Therefore, there is a need to adapt and implement early mobilization programs in Quebec hospitals. The overall goal of this study is to adapt and implement an early mobilization program in the Cardiovascular units of the Jewish General Hospital (JGH).

Read the detailed description

Background: Insufficient mobility contributes to functional decline in cardiovascular units. Early mobilization programs were shown to improve functional status, increase the likelihood of home discharges, and reduce the length of stay [1]. One example is the Level of Function (LOF) Mobility Scale implemented in the Cardiovascular units at the Jewish General Hospital, an academic tertiary care centre in Montreal, Quebec [2]. Despite evidence supporting the benefits of early mobilization programs, hospitalized individuals in cardiovascular units spend most of the day in bed [1-6]. Therefore, there is a need to adapt and implement early mobilization programs in Quebec hospitals. This project is research nested in a quality improvement initiative for the Jewish General Hospital Cardiovascular units.

Objectives: 1) Adapt an early mobilization program in a hospital setting; 2) Develop strategies to overcome individual and organizational barriers to implementing an early mobilization program; 3) Assess the reach, acceptability, and fidelity of implementing an early mobilization program; and 4) Assess the program's impact on patients and the organization.

Methods: A 3-phase study using an iterative participative approach. Phase 1: a qualitative design to adapt an early mobilization program. Phase 2: mixed methods repeated measures design to assess barriers and facilitators to implementing the program and develop implementation strategies.

Phase 3: An interrupted time series design to assess the implementation and the impact of the program.

Expected contribution: Early mobilization programs in the Cardiovascular units can improve the quality of care provided to these patients and promote further clinician-researcher partnerships, contributing to improved uptake of best practices in this clinical context.

Being tested
Applying the Early Mobilization Program
Keywords
Early mobilization program, cardiovascular, Level of mobility
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Applying the Early Mobilization ProgramBehavioural

    A mobilization intervention based on the level of function (LOF) ( i.e. patients should be assessed for mobilization status within 24 hours of admission; mobilization should occur at least three times a day, and mobility should be progressive and scaled, tailored to the patient's abilities); The frequency of patient mobilization (primary outcome) will be assessed 20 weeks before implementation, during the 20 weeks of implementation and 20 weeks after the end of implementation (60 weeks in total).

Study groups in NCT06393829
Study groupRoleWhat they receive
pre-implementationNo interventionThe proportion of patients mobilized pre-intervention period
ImplementationExperimentalThe proportion of patients mobilized during the intervention implementation period
Receives: Behavioral: Applying the Early Mobilization Program
Post-implementationNo interventionThe proportion of patients mobilized post-intervention period

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of implementation strategies developed to overcome the identified individual and organizational barriers and leverage the facilitators to implement an early mobilization program in this hospital setting.

    Investigators will develop strategies to overcome identified barriers and leverage the facilitators to implement the early mobilization program using data obtained from a mixed methods repeated measures design, including:

    1. Shadowing: an observational grid will be developed, including frequency of mobilization, length of mobilization activity, Health care professionals (HCPs) performing mobilization intervention, type of mobilization intervention, patient and caregiver acceptance and reaction, environmental barriers, available equipment, communication strategies among HCPs, reporting of mobilization interventions in the medical charts, clinicians' comment and observers' impressions and thoughts.
    2. HCPs will be invited to respond to a survey and participate in a focus group to assess perceived barriers and facilitators to early mobilization.
    3. Patients and caregivers will participate in a focus group to better understand barriers and facilitators to early mobilization.

    Measured: 3 months

  2. Number of patients mobilized divided by the total number of admitted patients during the evaluation period.

    Reach of the early mobilization program among patients will be measured with the following indicator: the number of patients mobilized (defined as the patient not being in bed during direct observation) divided by the total number of admitted patients during the evaluation period.

    Measured: 3 months

  3. Number of Patients refused being mobilized compared to number of admited patients during the evaluation period.

    Acceptability of the early mobilization program among patients will be measured with the refusal rate of being mobilized using the site's administrative data and a file audit that will include a form developed for this purpose.

    Measured: 3 months

  4. Number of days between admission and the development of a mobilization plan, between admission and first mobilization and number of patients with at least 3 mobilizations per day per week.

    Fidelity of intervention among HCPs will be measured with the following indicators:

    • Number of days between admission and the development of a mobilization plan
    • Number of days between admission and first mobilization
    • Number of patients with at least 3 mobilizations per day per week.

    Measured: 3 months

  5. Change in mobility levels during the unit's stay.

    Change in in mobility levels according to the LOF mobility scaleoccurring during the unit's stay.

    Measured: 3 months

  6. Change in number of Pressure ulcers occurance in the unit during the evaluation period.

    Change in Pressure ulcers rate in the unit during the evaluation period.

    Measured: 3 months

  7. Number of fall incidents occurring in the unit' during the evaluation period.

    Change in rate of falls occurring in the unit' during the evaluation period.

    Measured: 3 months

  8. Change in Length of stay

    Change in organizational outcomes measured by change in number of days the patient stay in the hospital.

    Measured: 3 months

  9. Number of patients discharged to home versus number discharged to an institutional care.

    Number of patients discharged to home versus number discharged to an institutional care used to evaluate the Effect of early monbilization on the discharge destination (home or institutional care).

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2024
  2. Study start1 Jun 2024 (estimated)
  3. Primary completion1 Apr 2026 (estimated)
  4. Study completion1 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Sequential
Model description
The proposed project will follow the steps of the Knowledge-to-Action framework (KTA) \[7\]. The KTA is a process model that provides practical guidance in planning and implementing research evidence into practice \[8\]. It is comprised of a Knowledge Creation Funnel and an Action Cycle. Our project will follow the steps of the Action Cycle from adapting to the local context through evaluating outcomes with a concern for sustaining knowledge use.
Masking
None (open label)
Enrolment
350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06393829
Sponsor's protocol ID
2024-4090
Status last verified
Apr 2024
First submitted
18 Mar 2024
Last updated
1 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The research assistant will de-identify the participants by generating a random code using a statistical method. The research team will extract and transfer the data using a password-protected Excel spreadsheet where modification is traceable. The private information (participant personal information, i.e., name, birth date) will be coded (unique code for each participant). The data capturing, coding, and analysis will be conducted on a password-protected computer at Constance Lethbridge Rehabilitation center connected to a secured server.

Publications

  • Anekwe DE, Biswas S, Bussieres A, Spahija J. Early rehabilitation reduces the likelihood of developing intensive care unit-acquired weakness: a systematic review and meta-analysis. Physiotherapy. 2020 Jun;107:1-10. doi: 10.1016/j.physio.2019.12.004. Epub 2019 Dec 19.

    PubMed 32135387
  • Dima D, Valiquette J, Berube-Dufour J, Goldfarb M. Level of function mobility scale for nurse-driven early mobilisation in people with acute cardiovascular disease. J Clin Nurs. 2020 Mar;29(5-6):778-784. doi: 10.1111/jocn.15124. Epub 2019 Dec 18.

    PubMed 31793086
  • Castro-Avila AC, Seron P, Fan E, Gaete M, Mickan S. Effect of Early Rehabilitation during Intensive Care Unit Stay on Functional Status: Systematic Review and Meta-Analysis. PLoS One. 2015 Jul 1;10(7):e0130722. doi: 10.1371/journal.pone.0130722. eCollection 2015.

    PubMed 26132803
  • TEAM Study Investigators; Hodgson C, Bellomo R, Berney S, Bailey M, Buhr H, Denehy L, Harrold M, Higgins A, Presneill J, Saxena M, Skinner E, Young P, Webb S. Early mobilization and recovery in mechanically ventilated patients in the ICU: a bi-national, multi-centre, prospective cohort study. Crit Care. 2015 Feb 26;19(1):81. doi: 10.1186/s13054-015-0765-4.

    PubMed 25715872
  • Zanni JM, Korupolu R, Fan E, Pradhan P, Janjua K, Palmer JB, Brower RG, Needham DM. Rehabilitation therapy and outcomes in acute respiratory failure: an observational pilot project. J Crit Care. 2010 Jun;25(2):254-62. doi: 10.1016/j.jcrc.2009.10.010. Epub 2009 Nov 26.

    PubMed 19942399
  • Dubb R, Nydahl P, Hermes C, Schwabbauer N, Toonstra A, Parker AM, Kaltwasser A, Needham DM. Barriers and Strategies for Early Mobilization of Patients in Intensive Care Units. Ann Am Thorac Soc. 2016 May;13(5):724-30. doi: 10.1513/AnnalsATS.201509-586CME.

    PubMed 27144796
  • Graham ID, Logan J, Harrison MB, Straus SE, Tetroe J, Caswell W, Robinson N. Lost in knowledge translation: time for a map? J Contin Educ Health Prof. 2006 Winter;26(1):13-24. doi: 10.1002/chp.47.

    PubMed 16557505
  • Nilsen P. Making sense of implementation theories, models and frameworks. Implement Sci. 2015 Apr 21;10:53. doi: 10.1186/s13012-015-0242-0.

    PubMed 25895742

Questions about this trial

What is this clinical trial studying?

A study testing Applying the Early Mobilization Program in people with Cardiovascular Diseases, run by Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Diana M Zidarov (5143402085 ext. 4711, diana.zidarov@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of implementation strategies developed to overcome the identified individual and organizational barriers and leverage the facilitators to implement an early mobilization program in this hospital setting. (time frame: 3 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06393829, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.

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