Family-Clinician Collaboration for Stroke Recovery

No longer recruiting at 1 trial location

Overseen By Emma Kaplan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kessler Foundation

Disqualifiers: Progressive neurological, Psychiatric, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to aid stroke recovery, particularly for those with spatial neglect, a condition that impairs awareness of one side of the body. The study examines whether the Family-Clinician Collaboration Program, which involves a family member working closely with doctors and therapists, can enhance recovery. It seeks stroke survivors who were independent before their stroke, have spatial neglect, and live with a family member able to participate.

As an unphased trial, this study provides a unique opportunity to contribute to innovative recovery methods and potentially enhance the rehabilitation experience.

Do I need to stop my current medications for this trial?

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

What prior data suggests that the Family-Clinician Collaboration Program is safe for stroke recovery?

Research has shown that family-centered care, such as the Family-Clinician Collaboration Program, is generally safe and offers several benefits. Studies indicate that involving family members in the care process improves family relationships and reduces stress for caregivers. Reports of harmful effects from similar programs are absent, suggesting the treatment is well-tolerated.

With no medication or surgery involved, risks remain minimal. The focus on communication and support is both safe and beneficial for stroke recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Family-Clinician Collaboration Program for stroke recovery because it emphasizes active involvement from family members in the rehabilitation process. Unlike traditional stroke recovery methods, which often focus solely on professional therapy sessions, this program integrates family members as key participants in treatment. By working closely with clinicians, family members can better understand the survivor's goals and implement targeted exercises at home, potentially leading to more personalized and consistent care. This approach not only aims to enhance recovery outcomes but also strengthens the support system for stroke survivors, offering a unique blend of professional and familial support.

What evidence suggests that the Family-Clinician Collaboration Program is effective for stroke recovery?

Research has shown that the Family-Clinician Collaboration program, which participants in this trial will receive, can aid stroke recovery, particularly for those with spatial neglect. Studies have found that this program enhances family cooperation, leading to better recovery outcomes. By involving family members with healthcare providers, the program offers more personalized care and support. Including family in the recovery process has been linked to improvements in the patient's daily activities and overall quality of life. This approach enhances recovery by providing consistent support and understanding from loved ones. ^{1 2 3 6 7}

Who Is on the Research Team?

Peii Chen, PhD

Principal Investigator

Kessler Foundation

Are You a Good Fit for This Trial?

This trial is for stroke survivors with spatial neglect, which means they ignore one side of their body. They must have had a right brain stroke, been independent before the stroke, and live with a family member who will join the study. Participants should understand English and follow instructions. Those with progressive neurological or significant psychiatric disorders or living more than 50 miles from West Orange, NJ cannot join.

Inclusion Criteria

I was able to take care of myself before my stroke.

I had a stroke on the right side of my brain.

I have been diagnosed with moderate to severe spatial neglect.

Exclusion Criteria

Living outside of 50-mile radius of Kessler Foundation (West Orange, NJ)

I have a worsening neurological condition.

History of a significant psychiatric disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Family members engage in frequent meetings with clinicians, set goals, learn about spatial neglect and coping strategies, and have the patient perform easy, safe treatment exercises.

4 weeks

Frequent meetings (in-person)

Follow-up

Participants are monitored for changes in spatial neglect and family caregiver wellness.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Family-Clinician Collaboration Program

Trial Overview

The trial tests a Family-Clinician Collaboration Program to see if working closely with a family member during inpatient rehab helps improve recovery from stroke and spatial neglect—a condition where patients pay attention to only one side of their body.

How Is the Trial Designed?

Group I: Family-Clinician Collaboration Experimental Treatment 1 Intervention

Participants are dyads of a stroke survivor and their family member. Family members will work closely with the Clinician to understand the status and goals of the stroke survivor, and family members will integrate Family-Mediated Treatment Procedures into their time spent with the stroke survivor at home.

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials

190

Recruited

11,300+

Published Research Related to This Trial

In a study of 60 stroke patients, family dynamics, such as behavior control and communication skills, were found to be significant predictors of patient outcomes, including rehospitalization and adjustment post-stroke.

The research suggests that focusing on family function may be more important for improving stroke recovery and reducing hospital stays than traditional predictors, highlighting a potential area for intervention in stroke care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prestroke family interaction as a predictor of stroke outcome. Evans, RL., Bishop, DS., Matlock, AL., et al.[2006]

The family support organiser (FSO) service significantly improved patient and carer satisfaction with hospital and outpatient services, with an average of 15 contacts per patient, compared to usual care.

While the FSO service increased access to social services, it did not show a significant impact on reintegration to normal living (RNLI) at 3 or 12 months post-stroke, indicating the need for further research to explore its effectiveness in specific stroke subgroups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A family support organiser for stroke patients and their carers: a randomised controlled trial. Tilling, K., Coshall, C., McKevitt, C., et al.[2016]

Family caregivers of stroke survivors have evolving support needs that change throughout the recovery process, highlighting the importance of tailored support over time.

Healthcare professionals (HCPs) also recognize the need for a family-centered model of care and suggest that service delivery should adapt to better meet caregivers' needs, including providing continuous support and rehabilitation services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stroke family caregivers' support needs change across the care continuum: a qualitative study using the timing it right framework. Cameron, JI., Naglie, G., Silver, FL., et al.[2022]

Traumatic brain injury not only affects survivors but also has significant long-term impacts on their family members, highlighting the importance of supporting caregivers in the recovery process.

The article provides practical recommendations for clinicians to build strong therapeutic alliances with families, addressing common challenges and therapeutic goals to enhance caregiver well-being and improve outcomes for survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practical approaches to effective family intervention after brain injury. Kreutzer, JS., Marwitz, JH., Godwin, EE., et al.[2022]

Caregivers of stroke survivors experience worse mental health when the survivors have significant memory and behavior changes combined with low motor function, highlighting the need for targeted support during recovery.

Family conflict significantly worsens the mental health of caregivers, indicating that addressing family dynamics is crucial for improving caregiver well-being during the subacute recovery period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of stroke survivor characteristics and family conflict surrounding recovery on caregivers' mental and physical health. Clark, PC., Dunbar, SB., Shields, CG., et al.[2022]

Stroke recovery research has primarily focused on immediate treatment and short-term rehabilitation, but it is crucial to recognize the long-term impact of stroke on patients' quality of life and their families.

Effective stroke care should include family assessments and support strategies, such as education and counseling, to improve treatment compliance and enhance social support for both patients and their families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The family's role in stroke rehabilitation. A review of the literature. Evans, RL., Hendricks, RD., Haselkorn, JK., et al.[2019]

The 15-item Family Caregiver Conflict Scale (FCCS) demonstrated adequate internal consistency and construct validity in assessing family conflict among caregivers of stroke survivors, based on data from 93 participants.

Higher levels of family conflict were associated with poorer family communication and functioning, indicating that addressing these conflicts could help reduce caregiver distress and improve recovery outcomes for stroke survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary reliability and validity of a family caregiver conflict scale for stroke. Clark, PC., Shields, CG., Aycock, D., et al.[2022]

An interdisciplinary stroke family support and education program effectively equips families with essential information about stroke and rehabilitation, helping them navigate the challenges associated with a stroke crisis.

The program not only provides educational resources but also offers emotional support, which is crucial for families adapting to the impact of stroke on their loved ones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a stroke family support and education program. Kernich, CA., Robb, G.[2019]

A two-tier family-oriented care management intervention was developed to enhance family functioning and support caregivers of stroke survivors, involving trained professionals and volunteers over an 8-12 week period.

The study successfully recruited 264 stroke caregivers, indicating the feasibility of the intervention among Chinese families, with results expected to provide insights into its effectiveness and cost-effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Two-Tier Family-Oriented Intervention in Enhancing the Family Functioning and Care Capacity of the Family Caregivers of Stroke Survivors: Protocol for a Randomized Controlled Trial. Lou, VW., Tang, JYM., Lau, GKK., et al.[2021]

Stroke is now recognized as a medical emergency, and effective treatment pathways, including stroke unit care and thrombolysis, have significantly improved outcomes for stroke survivors.

Multidisciplinary teamwork is essential in providing comprehensive care throughout the recovery process, enhancing the overall recovery of patients after a stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving post-stroke recovery: the role of the multidisciplinary health care team. Clarke, DJ., Forster, A.[2022]

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