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Improving Family Engagement in Acute Cardiovascular Care: The NGAGE Trial

Real-Time Feedback to Improve Family Engagement in Acute Cardiovascular Care

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05939427
Acronym
NGAGE
Enrollment
88
Registered
2023-07-11
Start date
2023-04-01
Completion date
2024-12-01
Last updated
2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Family Engagement

Brief summary

The objective of this study is to assess if the NGAGE real-time feedback tool improves family engagement in family members of people admitted to an acute cardiac care unit The investigators will randomize 88 family members of people hospitalized in the acute cardiac ward in a 1:1 manner to either the NGAGE intervention or usual care. Family members will be eligible if the expected unit stay of their loved one is \>48 hours and if they can communicate in English or French. A family member is considered anyone with a biological, emotional, or legal relationship with the patient whom the patient wishes to be involved in their care. The primary outcome of the study will be the FAMily Engagement (FAME) score at hospital discharge. Secondary outcomes will be family mental health (by HADS score) and family care satisfaction (by FS-ICU score).

Interventions

Will have access to the NGAGE tool to learn about engaging in care and to request engagement activities.

Sponsors

Lady Davis Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Family member of CV patient with expected stay \> 48 hours (as per treating team) * Aged of at least 18 years old * Ability to communicate in English or French * Willing to fill out the questionnaires as per the study

Exclusion criteria

* Expected stay of \< 48 hours * Inability to communicate in English or French

Design outcomes

Primary

MeasureTime frameDescription
Family Engagement (FAME) scoreWithin 48-hours of hospital dischargeAn engagement score that measures the following domains: family presence, family needs, communication and education, decision making, and direct care. Family-centered care principles are also captured such as dignity and respect, information sharing, participation and collaboration. The score is continuous and ranges from 0 to 100, with higher scores indicating increased levels of care engagement.

Secondary

MeasureTime frameDescription
Mental healthWithin 48-hours of hospital dischargeThe Hospital Anxiety and Depression Scale (HADS) is a self-reported tool to measure anxiety and depression. Scores range from 0-14 with higher scores indicating increased levels of anxiety and depression.
Family satisfactionWithin 48-hours of hospital dischargeThe Family Satisfaction in the Intensive Care Unit (FS-ICU) tool is used to assess the family satisfaction and experience with care in the ICU. Scores range from 0-100 with higher scores indicating increased family satisfaction.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026