- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07625098
Feasibility of SUPPORT-TBI
1. června 2026 aktualizováno: 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.
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
Intervence / Léčba
Detailní popis
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).
Typ studie
Intervenční
Zápis (Odhadovaný)
60
Fáze
- Fáze 1
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Jessica Kersey, PhD, OTR/L
- Telefonní číslo: 3142737540
- E-mail: jkersey@wustl.edu
Studijní záloha kontaktů
- Jméno: Curtis Comer, Clinical Research Coordinator I
- Telefonní číslo: 3142733288
- E-mail: curtisccomer@wustl.edu
Studijní místa
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Missouri
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St Louis, Missouri, Spojené státy, 63110
- Washington University School of Medicine
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Kontakt:
- Jessica Kersey, PhD, OTR/L
- Telefonní číslo: 3142737540
- E-mail: jkersey@wustl.edu
-
Kontakt:
- Curtis Comer, Clinical Research Coordinator I
- E-mail: jkersey@wustl.edu
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Vrchní vyšetřovatel:
- Jessica Kersey
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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)
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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HEAL Treatment Expectancy Short Form
Časové okno: Immediately at the conclusion of each intervention session (included as part of the interventionist's session documentation)
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6-item measure of intervention satisfaction with a 5-point Likert scale (range 6-30).
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Immediately at the conclusion of each intervention session (included as part of the interventionist's session documentation)
|
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Pittsburgh Rehabilitation Participation Scale
Časové okno: Immediately at the conclusion of each intervention session (included as part of the interventionist's session documentation)
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Measure of engagement in intervention sessions (range 1-6); administered each session and combined into an intervention-wide engagement score.
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Immediately at the conclusion of each intervention session (included as part of the interventionist's session documentation)
|
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Study-specific fidelity checklist
Časové okno: Immediately at the conclusion of each intervention session (included as part of the interventionist's session documentation)
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Checklist measuring the percentage of adherence to the outlined intervention elements; administered each session and combined into an intervention-wide adherence rate.
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Immediately at the conclusion of each intervention session (included as part of the interventionist's session documentation)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
MOS Social Support Survey
Časové okno: Baseline, Post-intervention (12 weeks)
|
19-item questionnaire examining perceived social support on a 5-point Likert scale with transformed scores (0-100).
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Baseline, Post-intervention (12 weeks)
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PROMIS Ability to Participate in Social Roles and Activities
Časové okno: Baseline, Post-intervention (12 weeks)
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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
Časové okno: Baseline, Post-intervention (12 weeks)
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29-item measure of multiple health domains using a 5-point Likert scale and reported as T-scores.
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Baseline, Post-intervention (12 weeks)
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Jessica Kersey, PhD, OTR/L, Washington University School of Medicine
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. června 2026
Primární dokončení (Odhadovaný)
31. prosince 2027
Dokončení studie (Odhadovaný)
31. března 2028
Termíny zápisu do studia
První předloženo
22. května 2026
První předloženo, které splnilo kritéria kontroly kvality
1. června 2026
První zveřejněno (Aktuální)
4. června 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
4. června 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
1. června 2026
Naposledy ověřeno
1. května 2026
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 202512160
- KL2TR002346 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu 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.
Časový rámec sdílení 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.
Kritéria přístupu pro sdílení 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.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- ICF
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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