Recovering Together for Neurological Injury

Overseen By Ana-Maria Vranceanu, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Cognitive impairment, Aphasia, Terminal diagnosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 6 weeks

388 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the present investigation is to test the efficacy of a brief (6 sessions) dyadic (patient and caregiver together) intervention to prevent chronic emotional distress in at risk dyads admitted to a Neuroscience Intensive Care Unit with an acute brain injury. Through this study, we seek to solve the unmet need of preventing chronic emotional distress in Neuroscience Intensive Care Unit (NICU) dyads through a feasible, acceptable and credible program, and ideally improve the recovery trajectory and dyads' overall quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Recovering Together for Neurological Injury?

The research highlights the importance of setting goals with patients and involving them in their rehabilitation process, which can lead to improved recovery outcomes. This approach is similar to the principles of the Recovering Together treatment, suggesting it may be effective in enhancing recovery from neurological injuries. ^{1 2 3 4 5}

How is the Recovering Together treatment different from other treatments for neurological injury?

Recovering Together is unique because it emphasizes a team-based approach to rehabilitation, involving an interdisciplinary team working closely with patients to improve recovery outcomes. This collaborative method is distinct from traditional treatments that may not integrate such comprehensive teamwork. ^{1 3 6 7 8}

Eligibility Criteria

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.

Inclusion Criteria

Patient and/or caregiver exhibit emotional distress on screening (using HADS D and/or HADS A scores > 7)

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

I am 18 years old or older.

Exclusion Criteria

Current untreated or unstable severe mental health conditions like bipolar disorder, schizophrenia, or active substance use

I do not have severe cognitive issues or speech problems that would prevent me from participating.

Terminal diagnosis

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a dyadic intervention consisting of 6 sessions to prevent chronic emotional distress

6 weeks

2 visits (in-person or virtual), 4 visits (virtual)

Follow-up

Participants are monitored for emotional distress and other outcomes after treatment

3 months

Assessments at baseline, 6 weeks, and 3 months

Treatment Details

Interventions

• Recovering Together

Trial Overview '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.

Participant Groups

Group I: Experimental Patient-Caregiver Dyads Experimental Treatment 1 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 Dyads Active Control 1 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 educational.

Recovering Together is already approved in United States for the following indications:

Approved in United States as Recovering Together for:

• Prevention of chronic emotional distress in Neuroscience Intensive Care Unit (NICU) dyads

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Findings from Research

The intervention aimed at improving the alliance between the interdisciplinary team and clients with traumatic brain injury resulted in the treatment group showing higher functional status at discharge compared to the control group, indicating its potential efficacy.

A stronger team alliance was linked to better outcomes, including program completion, return to productivity, improved client relationships, reduced family discord, and fewer depressive symptoms, suggesting that enhancing team dynamics can positively impact recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of an interdisciplinary team intervention to improve therapeutic alliance in post-acute brain injury rehabilitation. Evans, CC., Sherer, M., Nakase-Richardson, R., et al.[2019]

In a study involving 116 patients across five rehabilitation facilities, common goals included improvements in walking, recreation, leisure, pain management, and transfers, highlighting the importance of patient-centered goal setting in rehabilitation.

Despite identifying and structuring patient goals using the International Classification of Functioning, Disability and Health (ICF), achieving these goals did not predict overall improvements in functioning, suggesting that other factors may also play a significant role in rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The ICF forms a useful framework for classifying individual patient goals in post-acute rehabilitation. Lohmann, S., Decker, J., Müller, M., et al.[2019]

The IMPROVE study is a longitudinal, multicenter research project that will follow stroke patients for up to one year after inpatient rehabilitation to better understand their long-term functional recovery and the factors influencing it.

The primary outcome will focus on hand motor function, measured by the Fugl-Meyer Assessment, providing objective data on recovery dynamics and helping to inform future rehabilitation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for a multicenter observational prospective study of functional recovery from stroke beyond inpatient rehabilitation - The Interdisciplinary Platform for Rehabilitation Research and Innovative Care of Stroke Patients (IMPROVE). Birke, G., Wolf, S., Ingwersen, T., et al.[2022]

Involving patients in multidisciplinary goal setting during early rehabilitation after brain injury significantly increased the number of goals set per patient, from an average of 6.3 to 8.05, indicating enhanced engagement in their recovery process.

The intervention also led to a broader range of goals being established, particularly in areas like sleep and continence, without compromising the achievability of these goals, as the proportion of goals achieved remained consistent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient inclusion in goal setting during early inpatient rehabilitation after acquired brain injury. Dalton, C., Farrell, R., De Souza, A., et al.[2019]

The Brain Recovery Core system is a new organized approach to stroke rehabilitation that spans from hospital admission to community discharge, aiming to improve patient outcomes.

This multidisciplinary effort has led to significant changes in how rehabilitation services are delivered, enhancing the overall effectiveness of stroke recovery programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The brain recovery core: building a system of organized stroke rehabilitation and outcomes assessment across the continuum of care. Lang, CE., Bland, MD., Connor, LT., et al.[2019]

The article highlights the effectiveness of an interdisciplinary team approach in neurological rehabilitation services in North America, which enhances patient outcomes.

It provides a detailed description of the structure of the neurological rehabilitation team, emphasizing the collaboration among various healthcare professionals to optimize rehabilitation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Patient rehabilitation in Canada and the USA]. Marchuk, G., Tizel, P.[2016]

The study revealed that the structure and composition of neurological rehabilitation teams varied significantly, with inconsistencies in the adoption of interdisciplinary teamwork and patient involvement across different teams.

Therapists recognized the potential benefits of teamwork in rehabilitation, but the actual implementation of team processes was complex and diverse, indicating a need for more standardized approaches in practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapists' experiences and perceptions of teamwork in neurological rehabilitation: reasoning behind the team approach, structure and composition of the team and teamworking processes. Suddick, KM., De Souza, L.[2019]

Evidence-based interventions in neurological rehabilitation, such as constraint-induced movement therapy (CIMT) and robot-assisted training, have significantly improved motor functions and quality of life for patients with conditions like stroke and multiple sclerosis, as demonstrated through various therapeutic strategies over the past 20 years.

Early and frequent speech and language therapy (SLT) is crucial for effective recovery from communicative disorders, with PC-assisted training enhancing outcomes, highlighting the importance of tailored rehabilitation approaches for cognitive and communicative impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[DGRW-update: neurology--from empirical strategies towards evidence based interventions]. Schupp, W.[2011]

References

1. United States pubmed.ncbi.nlm.nih.gov

Evaluation of an interdisciplinary team intervention to improve therapeutic alliance in post-acute brain injury rehabilitation. [2019]

2. Sweden pubmed.ncbi.nlm.nih.gov

The ICF forms a useful framework for classifying individual patient goals in post-acute rehabilitation. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Protocol for a multicenter observational prospective study of functional recovery from stroke beyond inpatient rehabilitation - The Interdisciplinary Platform for Rehabilitation Research and Innovative Care of Stroke Patients (IMPROVE). [2022]

4. England pubmed.ncbi.nlm.nih.gov

Patient inclusion in goal setting during early inpatient rehabilitation after acquired brain injury. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

The brain recovery core: building a system of organized stroke rehabilitation and outcomes assessment across the continuum of care. [2019]

6. Ukraine pubmed.ncbi.nlm.nih.gov

[Patient rehabilitation in Canada and the USA]. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

Therapists' experiences and perceptions of teamwork in neurological rehabilitation: reasoning behind the team approach, structure and composition of the team and teamworking processes. [2019]

8. Germany pubmed.ncbi.nlm.nih.gov

[DGRW-update: neurology--from empirical strategies towards evidence based interventions]. [2011]