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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Health Promoting Lifestyle Profile II
研究概览
简要总结
To evaluate the efficacy of an adapted telehealth-based, health and wellness lifestyle program on promoting healthy lifestyle behaviors and improving health outcomes.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •non-English speaking
- •difficulty hearing
- •significant problems with communication
研究组 & 干预措施
Treatment
Health and Wellness Program
干预措施: Telehealth-Based Health and Wellness Program (POWERS-TBI) (Behavioral)
结局指标
主要结局
Health Promoting Lifestyle Profile II
时间窗: Up to 13 months
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
次要结局
- Barriers to Physical Activity and Disability Survey(Up to 13 months)
- Barriers to Health Activities among Disabled Persons scale(Up to 13 months)
- Patient Health Questionnaire-9 Item(Up to 13 months)
- Fatigue Severity Scale(Up to 13 months)
- Zarit Burden Scale(Up to 13 months)
- Social Support and Exercise Support for Eating and Physical Activity Habits(Up to 13 months)
- Stages of Change Readiness and Treatment Engagement Scale(Up to 13 months)
- Bodily Pain Index(Up to 13 months)
- Craig Handicap Assessment Reporting Technique short form(Up to 13 months)
- Perceived Wellness Survey(Up to 13 months)
- Sociodemographic Characteristics(Up to 13 months)
研究者
Laura E. Dreer, PhD
Associate Professor
University of Alabama at Birmingham