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

NCT ID: NCT01334398

Last Updated: 2014-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

74 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2014-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Traumatic Brain Injury

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Initial Treatment Group

Health & Wellness

Intervention Type BEHAVIORAL

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

Health & Wellness

Intervention Type BEHAVIORAL

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."

Interventions

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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."

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

* Failure to provide informed consent as evidenced by inability to respond to the above stated questions
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Craig Hospital

OTHER

Sponsor Role collaborator

VA Eastern Colorado Health Care System

FED

Sponsor Role lead

Responsible Party

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Lisa Brenner

Director, MIRECC

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lisa Brenner, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

VA VISN 19, ECHCS

Cynthia Braden (nee Dahlberg), MA

Role: PRINCIPAL_INVESTIGATOR

Craig Hospital

Locations

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VA ECHCS

Denver, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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H133A070022

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

07-1146

Identifier Type: -

Identifier Source: org_study_id