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

24 listopada 2014 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Rzeczywisty)

74

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka prawdopodobieństwa

Badana populacja

Veterans and community members

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
Initial Treatment Group
Behawioralne: 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
Behawioralne: 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."

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Ramy czasowe
Health Promoting Lifestyle Profile-II
Ramy czasowe: Baseline and Follow-up
Baseline and Follow-up

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

VA Eastern Colorado Health Care System

Współpracownicy

Craig Hospital

Śledczy

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

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 października 2008

Zakończenie podstawowe (Rzeczywisty)

1 listopada 2014

Ukończenie studiów (Rzeczywisty)

1 listopada 2014

Daty rejestracji na studia

Pierwszy przesłany

11 kwietnia 2011

Pierwszy przesłany, który spełnia kryteria kontroli jakości

12 kwietnia 2011

Pierwszy wysłany (Oszacować)

13 kwietnia 2011

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

25 listopada 2014

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

24 listopada 2014

Ostatnia weryfikacja

1 listopada 2014

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 07-1146
  • H133A070022 (Inny numer grantu/finansowania: NIDRR)

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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