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

NCT01334398 | Completed

• 2 other identifiers: 07-1146H133A070022
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Traumatic Brain Injury

Keywords

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• Health Promoting Lifestyle Profile-II

  Baseline and Follow-up

Study Arms (2)

Initial Treatment Group

Behavioral: Health & Wellness

Deferred Treatment Group

Behavioral: Health & Wellness

Interventions

Health & Wellness 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; Initial Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Veterans and community members

You may qualify if:

• individuals will be included in the study if they meet the following criteria:
• 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.
• received inpatient or outpatient rehabilitation, or an evaluation related to their TBI;
• are classified as moderate to severe TBI based on a TBI medical/professional evaluation;
• are at least one year post-injury;
• are 18 years of age or older at the time of the study;
• 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
• 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);
• 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;
• 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;
• 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);
• provide informed consent to participate.

You may not qualify if:

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

Sponsors & Collaborators

• VA Eastern Colorado Health Care System: lead
• Craig Hospital: collaborator

Study Sites (1)

VA ECHCS

Denver, Colorado, 80220, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Health

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

• Lisa Brenner, Ph.D.

  VA VISN 19, ECHCS

  PRINCIPAL INVESTIGATOR

• Cynthia Braden (nee Dahlberg), MA

  Craig Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, MIRECC

Study Record Dates

• First Submitted: April 11, 2011
• First Posted: April 13, 2011
• Study Start: October 1, 2008
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: November 25, 2014

Record last verified: 2014-11

Locations

US (1)