A Health and Wellness Lifestyle Program to Support Community-Dwelling Persons With Traumatic Brain Injury

Study Overview
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Brief Summary
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To evaluate the efficacy of an adapted telehealth-based, health and wellness lifestyle program on promoting healthy lifestyle behaviors and improving health outcomes.

Detailed Description
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The purpose of this study is to evaluate the efficacy of an adapted telehealth-based, health and wellness lifestyle program (POWERS-TBI) on promoting healthy lifestyle behaviors and improving self-efficacy for healthy activities such as amount of physical activity, dietary/food intake, mental stimulation and activity, substance use, mindfulness/spirituality, social relationships, and/or leisure activities among persons with TBI and their caregivers. The treatment program will be delivered via the internet, along with ongoing telephone health coaching calls designed to motivate, problem-solve challenges, reinforce skills learned, and prevent relapse. The goals are to evaluate the impact of the treatment program on improving health outcomes for people with TBI. The investigators plan to accomplish this by evaluating the impact of the program using a case-control crossover design.

Official Title
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A Health and Wellness Lifestyle Program to Support Community-Dwelling Persons With Traumatic Brain Injury (TBI) and Their Caregivers: In-House Research Project, Objective 2

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Behavioral: Telehealth-Based Health and Wellness Program (POWERS-TBI)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: age 19 years or older sustained a TBI at least 6-months or greater out from injury willing to work on one or more health goals among any of the following areas of focus (e.g., health knowledge, physical activity/exercise, dietary intake/nutrition, stress management, mental activity/stimulation, social ' relationships, leisure, sleep, mindfulness/spirituality, substance use) able to potentially participate in physical activity or alter dietary intake, if that is a potential health goal (e.g., no medical contraindication given by their doctor) not currently enrolled in a health and wellness program or research study involving a health/wellness program or intervention indicates a potential health goal to lose weight and does not independently prepare their own meals, cook, grocery shop, but has a caregiver defined by providing some type of ongoing support (emotional or instrumental) who is willing to participate as a study partner during the intervention condition has access to a telephone has regular access to the internet from a computer or laptop not pregnant (due to the effect on engaging in certain health promoting behaviors such as weight loss) does not have a significant psychiatric disorder, such as schizophrenia or bipolar disorder (those with depression or anxiety will not be excluded) Exclusion criteria: non-English speaking difficulty hearing significant problems with communication
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: case-control crossover
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Health and Wellness Program | Behavioral: Telehealth-Based Health and Wellness Program (POWERS-TBI)<br>* The treatment program is interactive and will be delivered via the internet, along with ongoing telephone health coaching calls designed to motivate, problem-solve challenges, reinforce skills learned, and prevent relapse.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Promoting Lifestyle Profile II | HPLP-II; Total scores and subscale scores are summed and divided by number of items on each scale respectively for an average, with higher scores indicating greater lifestyle behaviors | Up to 13 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barriers to Physical Activity and Disability Survey | BPADS: Response choices (yes/no) for 31 items are summarized; 3 items are open-ended, higher scores indicate greater barriers | Up to 13 months | 
| Social Support and Exercise Support for Eating and Physical Activity Habits | SSES: Subscale scores are obtained for exercise support (ranging from 10 for friends and 10 for family to 80 for friends and 80 for family); higher scores indicate greater support | Up to 13 months | 
| Stages of Change Readiness and Treatment Engagement Scale | SOCRATES: Items are summed and averaged across each subscale: Recognition scores range from 7-35; Ambivalence scores range from 4-20; Taking Steps scale range from 8-40: Higher scores indicate greater motivation | Up to 13 months | 
| Patient Health Questionnaire-9 Item | PHQ-9: Scores are summed and range from 0 to 27, higher scores indicate greater depressive symptomatology | Up to 13 months | 
| Fatigue Severity Scale | FSS: Scores range from 9 to 63 with higher scores indicating greater fatigue | Up to 13 months | 
| Bodily Pain Index | BPI: Scores for the Interference scale are summed and average for a mean (range 0 to 70) with higher scores indicating greater pain interference | Up to 13 months | 
| Craig Handicap Assessment Reporting Technique short form | CHARTsf: Suscales scores are summed and averaged for respective scales with higher scores indicating greater community integration | Up to 13 months | 
| Perceived Wellness Survey | PWS: A total score and subscale scores are calculated with a formula and range between 36 to 316 and average with higher scores indicating greater personal wellness | Up to 13 months | 
| Barriers to Health Activities among Disabled Persons scale | BHADP: Ratings are summed across each item for how interfering they are with health promotion (range of possible scores 18 to 72) | Up to 13 months | 
| Zarit Burden Scale | ZBS: Scores are summed (ranges 0 to 48) for a total scores, higher scores are indicative of greater burden | Up to 13 months | 
| Sociodemographic Characteristics | No abbreviation: Frequencies, summed total, or averages are reported to characterize the sample | Up to 13 months |