Expired Study
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Denver, Colorado 80220


Purpose:

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.


Study summary:

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.


Criteria:

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


Study is Available At:


Original ID:

07-1146


NCT ID:

NCT01334398


Secondary ID:

H133A070022


Study Acronym:


Brief Title:

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


Official Title:

A Health & Wellness Intervention for Individuals With Traumatic Brain Injury


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

VA Eastern Colorado Health Care System


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Case Control, Time Perspectiv


Number of Arms:

0


Number of Groups:

2


Total Enrollment:

74


Enrollment Type:

Actual


Overall Contact Information

Official Name:Lisa Brenner, Ph.D.
Principal Investigator
VA VISN 19, ECHCS

Study Dates

Start Date:October 2008
Completion Date:November 2014
Completion Type:Actual
Primary Completion Date:November 2014
Primary Completion Type:Actual
Verification Date:November 2014
Last Changed Date:November 24, 2014
First Received Date:April 11, 2011

Study Outcomes

Outcome Type:Primary Outcome
Measure:Health Promoting Lifestyle Profile-II
Time Frame:Baseline and Follow-up
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Health & Wellness
Description: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."
Arm Name:Initial Treatment Group

Study Arms

Study Arm Type:Other
Arm Name:Deferred Treatment Group
Study Arm Type:Other
Arm Name:Initial Treatment Group

Study Agencies

Agency Class:U.S. Fed
Agency Type:Lead Sponsor
Agency Name:VA Eastern Colorado Health Care System
Agency Class:Other
Agency Type:Collaborator
Agency Name:Craig Hospital

Samples and Retentions

Study Population: Veterans and community members
Sample Method:Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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