Behavioral Trial Studying Programmed Training to Improve Advocacy Skills for Individuals With Traumatic Brain Injury (MAP)
16 gennaio 2013 aggiornato da: Allen Brown, Mayo Clinic
Midwest Advocacy Project: A Community-based Randomized Practical Behavioral Trial of Programmed Advocacy Training for Individuals With Traumatic Brain Injury and Their Significant Others
The Midwest Advocacy Project (MAP) is a community-based multiple-site randomized practical behavioral trial of advocacy skill training for individuals with traumatic brain injury (TBI), their families, and significant others. The purpose is to evaluate the efficacy of a 4-session advocacy training program to improve behavioral advocacy skills compared to self-directed advocacy training of the same session frequency. Groups will be randomly assigned to either a programmed group or a self-directed group in collaboration with the Brain Injury Associations of Minnesota, Iowa, and Wisconsin each year over the 5 year study period. The primary outcome is pre-post measures of written and verbal advocacy skill measured by the Advocacy Behavior Rating Scale.
It is hypothesized that subjects who receive programmed advocacy training will show greater positive change on pre-post measures of advocacy skill measures than subjects receiving self-directed training.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
234
Fase
- Fase 2
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Iowa
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Urbandale, Iowa, Stati Uniti, 50322
- Brain Injury Association of Iowa
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Minnesota
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Minneapolis, Minnesota, Stati Uniti, 55413
- Brain Injury Association of Minnesota
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Wisconsin
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Pewaukee, Wisconsin, Stati Uniti, 53072
- Brain Injury Association of Wisconsin
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- 18 years of age or older
- moderate-severe TBI as indicated by one of the following:
- post traumatic amnesia (PTA) > 24 hours
- or loss of consciousness > 30 minutes
- or neuroimaging evidence of trauma-related intracranial abnormality
- Or the family/significant other of an individual with TBI meeting the above criteria
- 1 or more years post-injury
- Functional English speaker
- Signed consent to participate
Exclusion Criteria:
- Severe cognitive impairment as indicated by one or more of the following:
- Disorientation to person or year
- Unable to complete pre-program interview because of severe communication limitations
- Unable to remember important information given in the course of the pre-program interview, such as, time and place of program, number of sessions, and contact person
- Unable to complete the pre-program interview because of loss of emotional control, such as, extended tearfulness, sustained anger, verbal attack on interviewer
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Curriculum
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Day-long presentation of an advocacy training curriculum by the state's Brain Injury Association staff: One session per month for 4 consecutive months.
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Comparatore attivo: Self-directed
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Day-long group-based self-directed advocacy training activity: One session per month for 4 consecutive months.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Score on the Advocacy Behavior Rating Scale
Lasso di tempo: Written and verbal (video) advocacy statements are obtained twice from each subject and rated by blinded investigators: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
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Written and verbal (video) advocacy statements are obtained twice from each subject and rated by blinded investigators: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Score on Advocacy Activity Scale
Lasso di tempo: The Advocacy Activity Scale score is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
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The Advocacy Activity Scale score is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
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Score on the Perceived Control Scale for Brain Injury
Lasso di tempo: The Perceived Control Scale for Brain Injury score is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
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The Perceived Control Scale for Brain Injury score is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
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The Craig Hospital Inventory of Environmental Factors-Short Form
Lasso di tempo: The Craig Hospital Inventory of Environmental Factors-Short Form score is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
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The Craig Hospital Inventory of Environmental Factors-Short Form score is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
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The Satisfaction with Life Scale
Lasso di tempo: The Satisfaction with Life Scale is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
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The Satisfaction with Life Scale is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
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The SF-12
Lasso di tempo: The SF-12 score is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
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The SF-12 score is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
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Advocacy Activity Scale
Lasso di tempo: Every 6 months after intervention until the end of the 5-year study period
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Every 6 months after intervention until the end of the 5-year study period
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Allen W Brown, MD, Mayo Clinic
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 agosto 2007
Completamento primario (Effettivo)
1 settembre 2012
Completamento dello studio (Effettivo)
1 settembre 2012
Date di iscrizione allo studio
Primo inviato
22 ottobre 2009
Primo inviato che soddisfa i criteri di controllo qualità
26 ottobre 2009
Primo Inserito (Stima)
27 ottobre 2009
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
17 gennaio 2013
Ultimo aggiornamento inviato che soddisfa i criteri QC
16 gennaio 2013
Ultimo verificato
1 gennaio 2013
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 08-000981
- H133A070013-09
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .