- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07625098
Feasibility of SUPPORT-TBI
1. Juni 2026 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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).
Studientyp
Interventionell
Einschreibung (Geschätzt)
60
Phase
- Phase 1
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Jessica Kersey, PhD, OTR/L
- Telefonnummer: 3142737540
- E-Mail: jkersey@wustl.edu
Studieren Sie die Kontaktsicherung
- Name: Curtis Comer, Clinical Research Coordinator I
- Telefonnummer: 3142733288
- E-Mail: curtisccomer@wustl.edu
Studienorte
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Missouri
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St Louis, Missouri, Vereinigte Staaten, 63110
- Washington University School of Medicine
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Kontakt:
- Jessica Kersey, PhD, OTR/L
- Telefonnummer: 3142737540
- E-Mail: jkersey@wustl.edu
-
Kontakt:
- Curtis Comer, Clinical Research Coordinator I
- E-Mail: jkersey@wustl.edu
-
Hauptermittler:
- Jessica Kersey
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-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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)
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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HEAL Treatment Expectancy Short Form
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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MOS Social Support Survey
Zeitfenster: Baseline, Post-intervention (12 weeks)
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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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: Jessica Kersey, PhD, OTR/L, Washington University School of Medicine
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. Juni 2026
Primärer Abschluss (Geschätzt)
31. Dezember 2027
Studienabschluss (Geschätzt)
31. März 2028
Studienanmeldedaten
Zuerst eingereicht
22. Mai 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
1. Juni 2026
Zuerst gepostet (Tatsächlich)
4. Juni 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
4. Juni 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
1. Juni 2026
Zuletzt verifiziert
1. Mai 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 202512160
- KL2TR002346 (US NIH Stipendium/Vertrag)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
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.
IPD-Sharing-Zeitrahmen
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.
IPD-Sharing-Zugriffskriterien
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.
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- ICF
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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