- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07625098
Feasibility of SUPPORT-TBI
17 de agosto de 2026 atualizado por: Jessica Kersey, Washington University School of Medicine
From Isolation to Connection: A Dyadic Approach to Enhancing Health After TBI
Many people who have had a traumatic brain injury (TBI) struggle to stay connected with others.
They often lose friendships, become isolated, and have strained family relationships.
This lack of social support is linked to worse physical and mental health, lower quality of life, and even a shorter lifespan.
The investigators developed a program where a person with TBI and one close supporter work together with a therapist over 12 weekly sessions.
They learn skills in communication, setting shared goals, supporting each other emotionally, and problem-solving, with occasional guidance from a peer mentor who has been through a similar experience.
This study will determine whether the program is practical to deliver.
We are conducting a pilot study with 30 pairs of participants to test whether sessions run smoothly, whether people show up and stay engaged, and whether participants find the program worthwhile.
Based on what they learn, the investigators will refine this program before testing it on a larger scale.
If successful, this could lead to a practical, low-risk intervention that improves the lives of people with TBI and the family members and friends who support them.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Descrição detalhada
People with traumatic brain injury (TBI) experience poor long-term health and daily life participation, yet current rehabilitation approaches fail to meaningfully improve these outcomes.
Social support is closely associated with daily life participation and a range of physical and mental health outcomes.
Further, it is an important protective factor against functional decline, chronic disease, mental illness, and early mortality.
While social support is important for quality of life, few rehabilitation interventions leverage it as a mechanism for improving outcomes.
People with TBI have particularly low social support.
They experience shrinking social networks, loss of friendships, high rates of divorce, and reduced quality of family relationships.
Yet, people with TBI value strong reciprocal relationships with one or two close family members as the key component of social support.
This project will examine the feasibility of a novel dyadic intervention (SUPPORT-TBI) aimed at enhancing social support to promote greater participation and long-term health outcomes among people with TBI by improving the quality of a support relationship between the person with TBI and a close family member or friend.
The goals of this intervention are to provide the dyad with strategies to sustain an effective support relationship.
The investigators have designed SUPPORT-TBI to improve social support through five central intervention elements (1) communication strategies, (2) shared goals and activities, (3) psychosocial support, (4) peer mentorship, and (5) joint problem-solving.
This intervention was developed based on a core elements review of existing social support intervention literature in other fields and populations and was guided by input from people with brain injury, their family members, brain injury rehabilitation providers, and brain injury intervention researchers.
The investigators are currently refining it through a case series study.
Though conceptually promising, evidence-based, and rooted in stakeholder priorities, our early pilot testing of this intervention has demonstrated that the proposed 12 weekly sessions is a burdensome time commitment and is difficult to schedule when involving the person with TBI, their support person, and peer mentors.
These barriers, in addition to insurance barriers that limit coverage of outpatient and community-based rehabilitation services, suggest important implementation barriers that must be addressed as investigators refine this intervention protocol.
To address this, investigators propose to optimize the intervention using the Multiphase Optimization Strategy (MOST).
This framework will allow investigators to identify which intervention components, delivery structures, and dosages maximize efficiency without compromising intervention effects.
In the proposed study, investigators will conduct the preparation phase of the MOST framework, which involves testing the feasibility of the proposed intervention elements to inform the design of a factorial, randomized optimization trial (MOST Phase 2).
Investigators will conduct a feasibility study of the full protocol with 30 dyads, and examine participant satisfaction (HEAL Treatment Expectancy Short Form), engagement in intervention sessions(Pittsburgh Rehabilitation Participation Scale), and fidelity of delivery (study-specific fidelity checklist) of each intervention session.
Then the investigators will select the combinations of conditions to be tested in the optimization phase by refining the delivery of each intervention element for feasibility and identifying the intervention elements, dosages, and delivery models likely to contribute to intervention effects while minimizing participant burden.
This will enable the investigators to develop a thoughtful, comprehensive optimization study (MOST phase 2), and an eventual confirmation study to examine intervention effectiveness (MOST phase 3).
Tipo de estudo
Intervencional
Inscrição (Estimado)
60
Estágio
- Fase 1
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Jessica Kersey, PhD, OTR/L
- Número de telefone: 3142737540
- E-mail: jkersey@wustl.edu
Estude backup de contato
- Nome: Curtis Comer, Clinical Research Coordinator I
- Número de telefone: 3142733288
- E-mail: curtisccomer@wustl.edu
Locais de estudo
-
-
Missouri
-
St Louis, Missouri, Estados Unidos, 63110
- Recrutamento
- Washington University School of Medicine
-
Contato:
- Jessica Kersey, PhD, OTR/L
- Número de telefone: 3142737540
- E-mail: jkersey@wustl.edu
-
Contato:
- Curtis Comer, Clinical Research Coordinator I
- E-mail: jkersey@wustl.edu
-
Investigador principal:
- Jessica Kersey
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
Inclusion Criteria:
- Age 18 or older
- Live in a community setting (not an institutional setting)
- Sustained a traumatic brain injury more than 6 months prior to enrollment
- Report mild-moderate TBI-related disability (score of 5 or greater) on the Glasgow Outcome Scale - Extended
- Report low social support (score of less than 50 on the MOS Social Support Survey)
Exclusion Criteria:
- Insufficient English language fluency
- Active substance use disorder (meets diagnostic criteria on the PRIME-MD MINI alcohol or non-alcoholic substances modules)
- Active, untreated psychotic disorder (meets diagnostic criteria on the PRIME-MD MINI psychotic disorders module)
- Severe memory impairment (score of less than 21 on the Montreal Cognitive Assessment)
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: SUPPORT-TBI
This novel dyadic intervention incorporates essential elements of communication strategies, shared goals and activities, psychosocial support, peer mentorship, and problem-solving.
The person with TBI and a close supporter complete intervention procedures together and work to develop sustainable strategies for an effective support relationship.
The intervention is delivered in weekly 1-hour sessions for 12 consecutive weeks.
|
This novel dyadic intervention incorporates essential elements of communication strategies, shared goals and activities, psychosocial support, peer mentorship, and problem-solving.
The person with TBI and a close supporter complete intervention procedures together and work to develop sustainable strategies for an effective support relationship.
The intervention is delivered in weekly 1-hour sessions for 12 consecutive weeks.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
HEAL Treatment Expectancy Short Form
Prazo: Immediately at the conclusion of each intervention session (included as part of the interventionist's session documentation)
|
6-item measure of intervention satisfaction with a 5-point Likert scale (range 6-30).
|
Immediately at the conclusion of each intervention session (included as part of the interventionist's session documentation)
|
|
Pittsburgh Rehabilitation Participation Scale
Prazo: Immediately at the conclusion of each intervention session (included as part of the interventionist's session documentation)
|
Measure of engagement in intervention sessions (range 1-6); administered each session and combined into an intervention-wide engagement score.
|
Immediately at the conclusion of each intervention session (included as part of the interventionist's session documentation)
|
|
Study-specific fidelity checklist
Prazo: Immediately at the conclusion of each intervention session (included as part of the interventionist's session documentation)
|
Checklist measuring the percentage of adherence to the outlined intervention elements; administered each session and combined into an intervention-wide adherence rate.
|
Immediately at the conclusion of each intervention session (included as part of the interventionist's session documentation)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
MOS Social Support Survey
Prazo: Baseline, Post-intervention (12 weeks)
|
19-item questionnaire examining perceived social support on a 5-point Likert scale with transformed scores (0-100).
|
Baseline, Post-intervention (12 weeks)
|
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PROMIS Ability to Participate in Social Roles and Activities
Prazo: Baseline, Post-intervention (12 weeks)
|
Computer adaptive test examining social participation abilities; scores reported as T-scores.
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Baseline, Post-intervention (12 weeks)
|
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PROMIS-29
Prazo: Baseline, Post-intervention (12 weeks)
|
29-item measure of multiple health domains using a 5-point Likert scale and reported as T-scores.
|
Baseline, Post-intervention (12 weeks)
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Jessica Kersey, PhD, OTR/L, Washington University School of Medicine
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
17 de agosto de 2026
Conclusão Primária (Estimado)
31 de dezembro de 2027
Conclusão do estudo (Estimado)
31 de março de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
22 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
1 de junho de 2026
Primeira postagem (Real)
4 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
19 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
17 de agosto de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 202512160
- KL2TR002346 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
This study will produce feasibility data and clinical outcome data on 30 participants with brain injury and 30 support providers, comprising 30 total dyads who complete all research procedures together.
Data collection will be performed at Washington University medical campus or community sites in and around St. Louis, MO.
Session-level outcome data will include the patient-reported HEAL Treatment Expectancy short form, the HEAL Patient-Provider Connection short form, the Pittsburgh Rehabilitation Participation Scale, and our study-specific fidelity checklist.
Intervention-level outcome data will include the Client Satisfaction Questionnaire-8, MOS Social Support Survey, PROMIS Ability to Participate in Social Roles and Activities, and PROMIS-29.
Individual level processed data will be available for sharing.
Prazo de Compartilhamento de IPD
Data will be made available within 6 months of the end of the grant period and will remain available for a minimum of 10 years.
Critérios de acesso de compartilhamento IPD
There are no anticipated factors or limitations that will affect the access, distribution, or reuse of the de-identified scientific data generated by this proposal.
Controlled access will not be used.
The data that is shared will be shared by unrestricted download.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- CIF
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .