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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Health and Wellness Program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telehealth-Based Health and Wellness Program (POWERS-TBI) | Behavioral | 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. |
| 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 |
| 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 |
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Inclusion criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
Will need IRB approval
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D006293 | Health Promotion |
| ID | Term |
|---|---|
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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case-control crossover
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|
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 |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |