Communication Bridge: Optimizing an Evidence-based Intervention for Individuals With Primary Progressive Aphasia
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Change in Communication Participation Person Centered Goals
研究概览
简要总结
This study will use a randomized controlled trial design to evaluate the effect of two evidence-based treatments for adults with mild-moderate Primary Progressive Aphasia (PPA). The aim of the study is to help us better understand the effects of speech-language therapy on communication abilities in individuals with PPA.
详细描述
Participants with a diagnosis of PPA and their actively-engaged care partners will be involved in the study for approximately 17 months. Each participant will receive a laptop equipped with the necessary applications and features for the study. Participants will receive up to 10 evaluations and 20 speech therapy sessions with a licensed speech therapist, as well as access to Communication Bridge, a personalized web application to practice home exercises that reinforce treatment strategies. There are no costs to participate in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(person with PPA):
- •Meets diagnostic criteria for PPA based on neurologist and supporting medical assessments (extracted from medical records)
- •English as primary language used in daily communication activities (by self-report)
- •Adequate hearing (aided or unaided) for communicating with others in a crowded room (by self-report)
- •Adequate vision (aided or unaided) for reading a newspaper, or other functional materials (by self-report)
- •Able to pass technology screening and demonstrates sufficient knowledge for use of video conference and Communication Bridge™ web application use (with or without training)
- •Geriatric Depression Scale score ≤ 9
- •Mild-moderate PPA informed by a structured interview with a speech-language pathologist and a standardized testing battery.
- •Inclusion Criteria (Co-enrolled communication partner):
- •18+ years of age
- •English as primary language used in daily communication activities (by self-report)
- •Adequate hearing (aided or unaided) for communicating with others in a crowded room (by self-report)
- •Able to pass technology screening* and demonstrates sufficient knowledge for use of video conference and Communication Bridge™ web application use (with or without training)
排除标准
- •A dementia diagnosis other than Primary Progressive Aphasia
- •Participation is co-enrolled in an outside speech language therapy program during the study course.
- •Communication partners will be excluded if they have a pre-existing communication impairment that would affect study participation (e.g., aphasia, dementia)
- •Medical records will be requested and reviewed to determine eligibility
研究组 & 干预措施
Communication Bridge™
Participants receive Communication Bridge™, a multi-component, participation-focused, dyadic intervention in which both the person with PPA and their co-enrolled communication partner are intervention recipients. Communication Bridge™ is modelled on the Living with Aphasia: Framework for Outcome Measurement (A-FROM) and the Care Pathway Model that was developed for persons living with primary progressive aphasia. Consistent with participation-focused intervention models personally salient training stimuli are incorporated into all therapy activities in the Experimental arm.
干预措施: Communication Bridge™ (Behavioral)
Evidence-Based Impairment Focused
The Control arm includes a non-dyadic intervention in which the person with PPA is the active intervention recipient and their communication partner is in a supporting role. In the Control arm, participants receive a speech-language intervention designed to address impairment and functional limitations, comprised of activities that address word retrieval and 'automatic' speech production using fixed, non-personalized, stimuli across participants.
干预措施: Evidence-Based Impairment Focused (Behavioral)
结局指标
主要结局
Change in Communication Participation Person Centered Goals
时间窗: 5 assessment time points through study completion (up to 18 months)
Goal Attainment Scaling, a 7-point rating scale with -3 representing 'no longer participating' and +3 representing 'exceeded goal'. Higher scores indicate better progress in goal achievement.
Change in Communication Participation
时间窗: 5 assessment time points through study completion (up to 18 months)
The CPIB measure is a 10-item, disorder-generic, Likert scale that asks persons to rate how their condition interferes with participating in daily communication activities (e.g., talking to people you know/do not know, securing a turn in a fast-moving conversation). The psychometric properties of the measure have been published previously (Baylor et al., 2013; Baylor et al., 2019). Both raw and T-scores are available. The CPIB T-score has a theoretical mean of 50 and standard deviation of 10 with higher numbers reflecting higher levels of participation in communication activities.
Montgomery Burden Inventory (MBI)
时间窗: 5 assessment time points through study completion (up to 18 months)
The MBI is a pen/paper Likert scale with 16 items distributed across three subscales (Montgomery et al., 1985) completed by the care partner. Total and mean item scores are calculated for each of the three subscales: Objective burden is defined as the perceived infringement of disruption of tangible aspects of a caregiver's life; Subjective demand/relational burden is typically described as the extent to which the caregiver perceives that the care recipient is overly demanding in the context of caregiving; Subjective stress burden is the emotional impact of caregiving responsibilities. Participants rate each item with a score between 1 (Not at all) and 5 (A great deal) corresponding to the amount of perceived burden. Higher scores reflect increased burden. Internal consistency .81 to .90. Construct validity demonstrated in mixed cohort of care partners of persons with dementia. Test-retest stability coefficients are robust (ICC of 0.92 to 0.91) (Farley et al., 2010).
次要结局
未报告次要终点