Comparing Approaches to Helping People With Chronic Traumatic Brain Injury Manage Their Health Care
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Elder's Health Empowerment Scale (EHES)
研究概览
简要总结
The goal of this double-masked, randomized control trial is to learn about the potential benefits of two different strategies at helping people with traumatic brain injury who see a brain injury physician be more engaged in their healthcare and feel more confident in managing their health.
The main questions it aims to answer are:
- When comparing the two strategies, which will result in high participant-reported health empowerment assessed approximately 7 - 21 days of completing the approach?
- When comparing the two strategies, which will result in high participant-reported health engagement assessed approximately 7 - 21 days of completing the approach?
Participants will:
- complete baseline assessments about their health, daily activities, and their attitudes about healthcare and their treatment. These will be done over the phone and/or online survey.
- have one virtual session with a health professional to discuss their health and wellness.
- 7-21 days after the session with a health professional, participants will complete an online survey about their attitudes about healthcare and their treatment.
- Some participants may be invited to complete an additional interview about their study participation around 3 months after their session with the health professional.
详细描述
Phase II trial of PPC for persons with TBI versus resource education control; and qualitative input from selected participants. The study uses mixed methods including double-masked (neither participants nor researchers/assessors know which approach participants are receiving), parallel-group randomized, controlled trial (RCT) using a person-centered approach, Patient Priorities Care (PPC) to enhance health empowerment/self-efficacy and engagement, as compared to a resource education approach (control). Additionally, qualitative interviews will be conducted with selected participants to assess the experience (impact, satisfaction, barriers, and facilitators) of participating in the PPC approach among select adults with chronic TBI randomized to that approach arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •community dwelling adult (>18 years at enrollment)
- •≥1-year post-TBI that resulted in loss of consciousness based on The Ohio State University-TBI Identification Method
- •followed by a brain injury physician for TBI care who refers them to the study
- •must have sufficient comprehension, communication, sensorimotor function, and English proficiency (due to outcome measures not being validated in languages other than English)
- •must provide informed consent and have webcam and Internet access for assessments and approach
- •Additionally, meet 1 or more of the following criteria:
- •2 or more current chronic conditions (including chronic TBI)
- •5 or more medications
- •3 or more emergency department visits within the past 12 months
- •1 or more hospital admissions within the past 12 months
- •Under care of 2 or more specialists (non-primary care), including physicians, midlevel providers, therapists, mental health professionals) with visits with these providers in the past 12 months
排除标准
- •non-community dwelling
研究组 & 干预措施
Patient Priorities Care (PPC)
The PPC approach consists of one 30 minute session with a health professional to identify patient priorities.
干预措施: Patient Priorities Care (PPC) (Behavioral)
Resource Education
The Resource Education approach consists of one 30 minute session with a health professional about resources on living with brain injury.
干预措施: Resource Education (Behavioral)
结局指标
主要结局
Elder's Health Empowerment Scale (EHES)
时间窗: collected at baseline and post-approach (approximately 7 - 21 days).
A validated self-report instrument designed to measure health empowerment among older adults. The EHES evaluates multiple dimensions of empowerment, including self-control, self-efficacy, problems solving, psychosocial coping, support, motivation, and decision making. The 8-item scale is rated on a Likert-type scale, with higher scores indicating greater levels of health empowerment. The instrument has demonstrated good psychometric properties, including reliability and validity, making it suitable for use in research examining health behaviors, healthcare engagement, and outcomes among older adult populations. The EHES is particularly useful in studies investigating interventions aimed at promoting self-management, patient activation, or healthcare participation among elderly individuals, as it provides a quantifiable measure of empowerment-related constructs that are increasingly recognized as important factors in successful aging and chronic disease management.
Patient Activation Measure (PAM)
时间窗: collected at baseline and post-approach (approximately 7 - 21 days).
a 10-item measure of how informed and involved individuals are in their healthcare. It uses a 0-100 scale, segmenting activation into four levels, with higher scores indicating greater engagement. A unidimensional, interval-level, Guttman-like scale, PAM has strong psychometric properties and predicts key health behaviors, outcomes, and costs (obtaining screenings, immunizations, healthy diet, regular exercise, self-management, health-information seeking, better health outcomes and lower utilization and costs). PAM scores improve with supports and interventions and the PAM is a reliable and valid instrument for research in patients with neuro-logical conditions.
次要结局
未报告次要终点
研究者
Flora Hammond
Principal Investigator
Indiana University