Communication Bridge: A Person-centered Internet-based Intervention for Individuals With Primary Progressive Aphasia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- Change in Communication Confidence (CCRSA)
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 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.
Participants with a diagnosis of PPA and their actively-engaged care partners will be involved in the study for 12 months. Each participant will receive a laptop equipped with the necessary applications and features for the study. Participants will receive 5 evaluations and 15 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
- Double (Participant, Outcomes Assessor)
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
- 未提供
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.
结局指标
主要结局
Change in Communication Confidence (CCRSA)
时间窗: 5 assessment time points through study completion - Baseline, Post Intervention 1 (3 months), Six months, Post Intervention 2 (9 months), and 12 months
Communication Confidence Rating Scale in Aphasia, a 0-100 numeric rating scale with 0 representing 'not confident' and 100 representing 'very confident'. Higher scores indicate greater confidence.
Change in Communication Participation Item Bank (CPIB)
时间窗: 5 assessment time points through study completion - Baseline, Post Intervention 1 (3 months), Six months, Post Intervention 2 (9 months), and 12 months
Communication Participation Item Bank is a 4-point rating scale with 0 representing 'very much' and 3 representing 'not at all'. Higher scores indicate greater severity of communication challenges. We are reporting on change in CPIB scores using T-scores. The Communicative Participation Item Bank (CPIB) T-score range is as follows: T57.5 and above: Represents a "normal" experience of communicative participation or "minimal problems" T57.5-T45: Represents mild challenges T45-T35: Represents moderate challenges T35 and below: Represents severe challenges The CPIB is a patient-reported instrument that measures communicative participation. The mean T-score is 50, and the standard deviation is 10. Higher scores are more favorable, indicating less interference in participation. The ideal score, or someone who reports no problems with communicative participation, would be a T-score of 74.3
Change in Communication Participation Person Centered Goals
时间窗: 4 assessment time points through study completion - Post Intervention 1 (3 months), Six months, Post Intervention 2 (9 months), and 12 months
This measure assesses progress toward communication participation goals using Goal Attainment Scaling (GAS). Participants developed personalized goals, each set to a baseline value of '0'. Progress was tracked using a 7-point scale, where -3 represents 'no longer participating' and +3 represents 'exceeded goal'. Higher scores indicate better progress toward goal achievement. Goals were evaluated at 3, 6, 9, and 12 months, with the results reported as the percentage of goals that: Worsened (scores of -1, -2, or -3) No change (score remained at 0) Improved (scores of +1, +2, or +3), including getting close to, reaching, or exceeding the goal. The table below presents the percentage of goals falling into each of these categories at each assessment point.
次要结局
未报告次要终点