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Recovering Together for Neurological Injury

N/A

Recruiting

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Hospitalized with any ANI within 6 weeks (patient) OR informal caregiver of a patient currently admitted with any ANI

Age 18 or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0 weeks, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 3 months

Awards & highlights

Study Summary

This trial will test whether a brief emotional intervention can help prevent chronic distress for patients and caregivers admitted to a NICU after a brain injury.

Who is the study for?

This trial is for pairs of patients with acute neurological injuries (ANI) in the Neuro-ICU and their informal caregivers. Participants must be over 18, speak English, and have internet access. They should show signs of emotional distress but not have severe mental health conditions or cognitive impairments that would hinder participation.Check my eligibility

What is being tested?

'Recovering Together' is a brief intervention program being tested to see if it can prevent long-term emotional distress in patient-caregiver dyads dealing with ANI. The study involves six sessions aimed at improving recovery outcomes and overall quality of life.See study design

What are the potential side effects?

Since 'Recovering Together' is a psychological support intervention rather than a medical treatment, there are no direct physical side effects expected. However, discussing emotional topics could potentially cause temporary discomfort or stress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was hospitalized for an acute neurological incident within the last 6 weeks OR I am caring for someone who is.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0 weeks, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0 weeks, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 weeks, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Emotional Distress

Secondary outcome measures

Change in Interpersonal Factors (avoidant or anxious communication)

Change in Interpersonal Factors (dyadic strain and positive interpersonal interactions)

Change in Interpersonal Factors (perceived social support)

+5 more

Other outcome measures

Change in Degree of disability or dependence (potential moderator)

Change in Independence in activities of daily living (potential moderator)

Demographic Factors (potential moderators)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Experimental Patient-Caregiver DyadsExperimental Treatment1 Intervention

There will be 6 sessions with 2 general sessions delivered in person at bedside in the NICU (or virtual depending on COVID and discharge status) and 4 tailored specific sessions (chosen from by the dyads from 6 available modules) to be delivered via live video using Zoom. Content will be primarily skills.

Group II: Control Patient-Caregiver DyadsActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Recovering Together

2019

N/A

~130

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,931 Previous Clinical Trials

13,198,057 Total Patients Enrolled

Media Library

Recovering Together Clinical Trial Eligibility Overview. Trial Name: NCT05157880 — N/A

Neurological Injury Research Study Groups: Control Patient-Caregiver Dyads, Experimental Patient-Caregiver Dyads

Neurological Injury Clinical Trial 2023: Recovering Together Highlights & Side Effects. Trial Name: NCT05157880 — N/A

Recovering Together 2023 Treatment Timeline for Medical Study. Trial Name: NCT05157880 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being recruited for participation in this research?

"Affirmative. In accordance with clinicaltrials.gov, this research project is actively attempting to recruit participants since its commencement on December 10th 2021 and last update on August 25th 2022. 388 individuals are being sought from a single site for participation in the trial."

Answered by AI

Is this experiment currently enrolling new participants?

"Indeed, the information hosted on clinicaltrials.gov reveals that this medical trial is presently looking for participants to enrol in the study. The original posting date was December 10th 2021 and it has been amended as of August 25th 2022. There are 388 patients needed from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Building Resiliency in Dyads of Patients With an ANI Admitted to the Neuro-ICU and Their Informal Caregivers

Ana-Maria Vranceanu, PhD 2021. "Building Resiliency in Dyads of Patients With an ANI Admitted to the Neuro-ICU and Their Informal Caregivers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05157880.