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Healing beyond surgery: new study tests emotional support for trauma patients

NCT ID NCT07584252

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding emotional and social support to standard medical care helps people recover from moderate to severe orthopedic injuries. It involves 804 patients, their care partners, and healthcare workers across multiple hospitals. The goal is to reduce anxiety and burnout by providing trauma-focused support during recovery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 804 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Mar 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Patients: Inclusion Criteria: 1. Age \>= 18 years 2. Anticipated hospital length of stay \> 72 hours 3. Moderate to severe orthopaedic trauma treated surgically for 1 or more injuries 4. GCS \>= 13 at the time of enrollment 5. Willing and able to meet with Evellere coach while hospitalized or via the telephone within 72 hours of discharge (intervention cohort only) Exclusion Criteria: 1. Non-english speaking (must be sufficiently fluent in English to consent and complete surveys without interpretive services) 2. Prior to index hospitalization, patient must not be receiving home services or be independent in daily tasks 3. Any penetrating brain injury 4. Patients with significant burn injury 5. Prior cognitive impairment 6. Hospital death or imminent death 7. Hospice care at time of trauma or selection for hospice during initial hospital admission or do not resuscitate or comfort care only before index visit 8. Prisoner/ inmate or police/ security intervention during hospitalization 9. No reliable internet access at baseline 10. Psychosis 11. Trauma presentation is a result of suicide attempt/ self-harm Care Partners Inclusion criteria: 1. Identified by the enrolled patient as a primary source of support during their recovery. A care partner can be in person or supporting remotely. 2. Age \>= 18 years 3. Willing and able to meet with an Evellere coach during patient hospitalization or via telephone within 72 hours of discharge (intervention cohort only) Exclusion criteria: 1. Non-english speaking (must be sufficiently fluent in English to consent and complete surveys without interpretive services) 2. Paid professionals or home healthcare providers whose support is provided as part of employment (e.g., nurses, aides, case managers) 3. Already enrolled as a care partner for another participant in the HEART Trial 4. Hospitalized at time of patient enrollment 5. No reliable internet access at baseline Healthcare Workers Inclusion criteria: 1. Age \> 18 years 2. Currently employed (full-time, part-time) at a participating trauma center in a role type associated with trauma care (e.g., engaged in clinical care navigation, behavioral health, rehabilitation, recovery coordination, etc.) 3. Provides or supports care for orthopedic trauma patients for ≥20% of their clinical time 4. Expected to remain employed at the trauma center for \>12 months after enrollment Exclusion criteria: 1. Are contracted staff or traveling temporary staff 2. Are students or trainees 3. No reliable internet access at baseline

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Conditions

The condition(s) this trial relates to.

injury Wounds, Nonpenetrating

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756, United States

  • Hennepin Healthcare

    Minneapolis, Minnesota, 55404, United States

  • Johns Hopkins University

    Baltimore, Maryland, 21218, United States

  • R Adams Cowley Shock Trauma Center

    Baltimore, Maryland, 21201, United States

  • The Ohio State University

    Columbus, Ohio, 43210, United States

  • University of Colorado Anschutz

    Aurora, Colorado, 80045, United States

  • Vanderbilt University

    Nashville, Tennessee, 37203, United States

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