- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07741149
Self-Management Training Among Individuals With TBI
Chronic Disease Self-Management Among Individuals With TBI
Traumatic brain injury (TBI) can have long-term and chronic effects on an individual's physical, social, and emotional health, impacting quality of life and the ability to engage in meaningful life roles. Despite the potential for long-term effects, much of the care for individuals with TBI is front-loaded in the weeks to months post-injury. Self-management and self-management training are key components of long-term care for many chronic health conditions, but they are not standard parts of care for individuals with TBI.
In this study the investigators will address two objectives: 1) identify self-management priorities from the perspectives of individuals with chronic TBI, families, and health care providers and 2) pilot test an existing virtual community-based self-management training program (the Chronic Disease Self-Management Program (CDMSP)), to a) evaluate changes in quality of life, self-management self-efficacy, and other patient-reported outcomes before and after participating in the training, and b) identify barriers and facilitators to participating in community-based self-management training.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Emily Evans, PT, PhD
- Telefonnummer: (617) 353 7493
- E-post: eaevans@bu.edu
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Aged ≥18 years at time of first TBI
- At least one year since the most recent TBI
- Received care at BMC's Concussion/TBI program for a TBI or concussion
- At least partially involved in Self-care
- Able to provide consent
- Able to speak and understand English
- Available for study duration.
Exclusion Criteria:
• Aged <18 at the time of their first TBI
- Severe mental, cognitive, social, or emotional difficulties due to another neurologic, developmental, psychological condition, or active substance use disorder
- Participating in another interventional clinical trial
- Planned major surgery in the next 4 months.
- Pregnancy (self-report).
- Suspected or known drugs or alcohol abuse
- Endorses suicidal ideation
- All individuals with reduced decision-making capacity, an assigned LAR, or conservator.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Self-management training
Individuals enrolled in this arm will participate in a community-based self management training program
|
Individuals will participate in a 6-week group training course run by a community-based organization that provides training in self-management skills for individuals with chronic health conditions.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
PROMIS Self-Efficacy to Manage Chronic Disease Scale
Tidsramme: baseline, after the intervention on average 6 weeks
|
A patient reported outcome measure that assesses self-efficacy to managing chronic disease across 5 domains: Managing: Symptoms, Social Interactions, Medications, Emotions, and Daily Activities
|
baseline, after the intervention on average 6 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Quality of Life After Brain Injury
Tidsramme: baseline, after the intervention on average 6 weeks
|
This tool was developed to assess quality of life among individuals with traumatic brain injury
|
baseline, after the intervention on average 6 weeks
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Emily Evans, PT, PhD, Boston University Charles River Campus
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 8410E
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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