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OpenTrials
Completed

NCT Number: NCT05939427

Improving Family Engagement in Acute Cardiovascular Care: The NGAGE Trial

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).

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Key information

Conditions

Family Engagement

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ladis Davis Institute

Montreal, Quebec, H3T1E2, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NGAGE tool

Other

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

Primary outcomes

  1. Family Engagement (FAME) score

    Time frame: Within 48-hours of hospital discharge

    An 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 outcomes

  1. Mental health

    Time frame: Within 48-hours of hospital discharge

    The 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.

  2. Family satisfaction

    Time frame: Within 48-hours of hospital discharge

    The 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.

Sponsors and collaborators

Lead sponsor

Lady Davis Institute

Other

Registry information

Official study title

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

Acronym: NGAGE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 11, 2023
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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