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A Health & Wellness Intervention for Individuals With Traumatic Brain Injury (TBI)

24. November 2014 aktualisiert von: Lisa Brenner, VA Eastern Colorado Health Care System

A Health & Wellness Intervention for Individuals With Traumatic Brain Injury

The primary goal of the proposed study is to evaluate the efficacy of a replicable community-based group intervention, designed to address both general wellness and specific TBI health-related issues. Emphasis is placed on goal setting to develop healthy habits, utilizing problem solving strategies, learning means of maintaining progress and setting new goals. Facilitators will utilize approaches aimed at maximizing participant self-efficacy, reducing barriers to health promotion, and developing personal resources. A randomized wait-list control group design will be used to evaluate the efficacy of the intervention. It is hypothesized that individuals with TBI who participate in the intervention group will report increased health promoting behaviors, health related self-efficacy, health-related quality of life, level of participation, and greater perceived wellness and satisfaction with life as compared to the control group.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Health promotion in the general population and in disability groups, such as individuals with TBI, has been identified in recent decades as a specific need by the Surgeon General, the U.S. Department of Health and Human Services Healthy People 2010, the NIDRR Rehabilitation Research and Training Center (RRTC) on Health and Wellness and the Centers for Disease Control and Prevention (CDC). Additionally, decreased quality of life and increased health-related secondary conditions in TBI supports the need for health and wellness promotion. A number of health and wellness programs have been developed for specific disabled populations, with a few providing evidence for efficacy; however, no evidence based program designed to meet the unique needs of individuals with TBI has been identified. This proposal responds to the NIDRR Long Range Plan and the Healthy People 2010 call for further research in health promotion to improve quality of life, decrease disability, and eliminate disparities in health within disability populations, specifically those individuals with TBI.

The primary goal of the proposed study is to evaluate the efficacy of a replicable community-based group intervention, designed to address both general wellness and specific TBI health-related issues. Emphasis is placed on goal setting to develop healthy living habits, utilize problem solving strategies, learn means of maintaining progress and set new goals. Facilitators will utilize approaches aimed at maximizing participant self-efficacy, reducing barriers to health promotion, and developing personal resources. A randomized wait-list control group design will be used to evaluate the efficacy of the intervention.

It is hypothesized that individuals with TBI who participate in the intervention group will report increased health promoting behaviors, health related self-efficacy, health-related quality of life, level of participation, and greater perceived wellness and satisfaction with life, than the control group. Intervention group members are expected to attain individualized health and wellness goals, and maintain gains on follow-up at six months. Findings from this study will advance knowledge regarding health and wellness intervention for individuals with TBI, and may clarify areas of future research.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

74

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Wahrscheinlichkeitsstichprobe

Studienpopulation

Veterans and community members

Beschreibung

Inclusion Criteria:

  • individuals will be included in the study if they meet the following criteria:

    1. history of TBI as defined as damage to brain tissue caused by an external mechanical force as evidenced by loss of consciousness or post traumatic amnesia (PTA) due to brain trauma or by objective neurological findings that can be reasonably attributed to TBI on physical examination or mental status examination.
    2. received inpatient or outpatient rehabilitation, or an evaluation related to their TBI;
    3. are classified as moderate to severe TBI based on a TBI medical/professional evaluation;
    4. are at least one year post-injury;
    5. are 18 years of age or older at the time of the study;
    6. function at Rancho Los Amigo Level of Cognitive Functioning Level of 6 or above, based on current interview with participant and family member/identified resource person
    7. have adequate receptive and expressive communication skills functional for group participation (score >5 on the Comprehension and Expression items of the Functional Independence Measure (FIM) based on current interview);
    8. have sufficient recall of day-to-day events for learning in the group setting, based on screening interview with family member or identified resource person;
    9. have the ability to participate in ongoing group sessions with no documented or reported medical or neurological conditions (e.g. upcoming hospitalizations, uncontrolled seizures), behavioral concerns (e.g. frustration tolerance, behavioral/anger control,) or other issues that preclude group participation;
    10. be English speaking in order to complete study measures (if the intervention is proven efficacious, future studies would be needed with non-English speaking participants);
    11. provide informed consent to participate.

Exclusion Criteria:

  • Failure to meet inclusion criteria
  • Failure to provide informed consent as evidenced by inability to respond to the above stated questions

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
Initial Treatment Group
Verhalten: Health & Wellness
The specific content of the intervention was adapted from four existing evidence-based interventions: (1) "Healthy Lifestyles for People with Disabilities," (2) Promoting Wellness for Women with MS," (3) "Living Well with Disability," and (4) "Social Skills and TBI: A Workbook for Group Treatment."
Deferred Treatment Group
Verhalten: Health & Wellness
The specific content of the intervention was adapted from four existing evidence-based interventions: (1) "Healthy Lifestyles for People with Disabilities," (2) Promoting Wellness for Women with MS," (3) "Living Well with Disability," and (4) "Social Skills and TBI: A Workbook for Group Treatment."

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Health Promoting Lifestyle Profile-II
Zeitfenster: Baseline and Follow-up
Baseline and Follow-up

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

VA Eastern Colorado Health Care System

Mitarbeiter

Craig Hospital

Ermittler

  • Hauptermittler: Lisa Brenner, Ph.D., VA VISN 19, ECHCS
  • Hauptermittler: Cynthia Braden (nee Dahlberg), MA, Craig Hospital

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

1. Oktober 2008

Primärer Abschluss (Tatsächlich)

1. November 2014

Studienabschluss (Tatsächlich)

1. November 2014

Studienanmeldedaten

Zuerst eingereicht

11. April 2011

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

12. April 2011

Zuerst gepostet (Schätzen)

13. April 2011

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

25. November 2014

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

24. November 2014

Zuletzt verifiziert

1. November 2014

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 07-1146
  • H133A070022 (Andere Zuschuss-/Finanzierungsnummer: NIDRR)

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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