Intervention to Promote Communication Quality of Life for Persons With Language-Led Dementia and Their Partners: A Randomized Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Maya Henry
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in spoken naming of trained/untrained items
研究概览
简要总结
The goal of this clinical trial is to learn whether a personalized, multi-component, virtual speech language treatment program can improve communication and quality of life for adults with primary progressive aphasia (PPA) and their primary communication partners. The study will enroll participants who speak English and/or Spanish.
The main questions the study aims to answer are:
- Is the telerehabilitation program feasible and acceptable for people with PPA and their study partners?
- Do participants with PPA and study partners find treatment beneficial?
- What patterns of treatment response are seen in participants?
- Which outcome measures are most useful for evaluating changes in communication and quality of life?
Researchers will compare participants who receive intervention immediately to participants assigned to a waitlist control group (who will receive treatment after a delay) to see whether participation in the treatment program is associated with improvements in communication and quality of life.
Participants will:
- Take part in speech language therapy sessions delivered by video visit that combine restorative, compensatory, and partner-focused communication strategies. Treatment may take place after a waiting period.
- Receive education and communication training together with their partner.
- Complete speech, language, and cognitive assessments.
- Complete questionnaires about communication abilities, daily functioning, and quality of life.
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
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for Persons with PPA:
- •A PPA (Gorno-Tempini et al., 2011) or "PPA-plus" (Mesulam et al., 2001) diagnosis
- •MMSE score of 15 or higher and must be able to produce single monosyllabic words intelligibly
- •Must speak English, Spanish or both languages (i.e., bilingual speakers of English or Spanish)
- •Hearing and vision adequate for participation in teleconference meetings
- •Must have a study partner available (someone who will commit to attending teleconference sessions, as needed, during assessment and treatment phases)
- •Inclusion criteria for Care Partners:
- •Partners must express willingness to attend and participate in assessment and treatment sessions, including those targeting dyadic communication goals
- •Partners must speak English, Spanish or both languages (i.e., bilingual speakers of English or Spanish)
- •Partner's hearing and vision should be adequate for participation in teleconference meetings
- •The participant and/or study partner must have basic experience using a computer.
排除标准
- •for persons with PPA:
- •Other central nervous system or medical diagnosis that can account for symptoms
- •Psychiatric diagnosis that can account for symptoms
研究组 & 干预措施
Waitlist Control
Individuals in the waitlist-control group will undergo initial assessment followed by a waiting interval of 12 (Multi-VISTA) or 13 (Multi-LRCT) weeks. Following the waiting period, they will again complete baseline assessments prior to the treatment phase (co-development of training materials and Multi-VISTA or Multi-LRCT treatment).
干预措施: Multicomponent Lexical Retrieval Cascade Training (Behavioral)
Waitlist Control
Individuals in the waitlist-control group will undergo initial assessment followed by a waiting interval of 12 (Multi-VISTA) or 13 (Multi-LRCT) weeks. Following the waiting period, they will again complete baseline assessments prior to the treatment phase (co-development of training materials and Multi-VISTA or Multi-LRCT treatment).
干预措施: Multicomponent Video Implemented Script Training in Aphasia (Behavioral)
Immediate Treatment
Individuals in the immediate treatment group will undergo initial assessment followed immediately by the treatment phase (co-development of training materials and Multi-VISTA or Multi-LRCT treatment).
干预措施: Multicomponent Lexical Retrieval Cascade Training (Behavioral)
Immediate Treatment
Individuals in the immediate treatment group will undergo initial assessment followed immediately by the treatment phase (co-development of training materials and Multi-VISTA or Multi-LRCT treatment).
干预措施: Multicomponent Video Implemented Script Training in Aphasia (Behavioral)
结局指标
主要结局
Change in spoken naming of trained/untrained items
时间窗: change from pre-treatment or waitlist to post-treatment or waitlist (12-13 weeks), and follow-up at 3 months post-treatment
Percent correctly named trained/untrained pictures
Change in script production accuracy
时间窗: change from pre-treatment or waitlist to post-treatment or waitlist (12-13 weeks), and follow-up at 3 months post-treatment
Percent correct intelligible, scripted words for trained/untrained scripts
Change in barriers and facilitators in dyad conversation
时间窗: change from pre-treatment or waitlist to post-treatment or waitlist (12-13 weeks), and follow-up at 3 months post-treatment
Number of conversation barriers and facilitators observed in conversation
Communication Modality Inventory
时间窗: change from pre-treatment or waitlist to post-treatment or waitlist (12-13 weeks), and follow-up at 3 months post-treatment
A likert-type survey characterizing frequency and type of communication modalities used in conversation, administered to both the person with PPA and their conversation partner.
Change in spoken naming of trained/untrained items
时间窗: change from pre-treatment to post-treatment (11 weeks after treatment onset) and follow-up at 3 months post-treatment
Percent correctly named trained/untrained pictures
Change in script production accuracy
时间窗: change from pre-treatment to post-treatment (9 weeks after treatment onset) and follow-up at 3 months post-treatment
Percent correct intelligible, scripted words for trained/untrained scripts
Change in barriers and facilitators in dyad conversation
时间窗: change from pre-treatment to post-treatment (9-11 weeks after treatment onset) and follow-ups at 3 months post-treatment
Number of conversation barriers and facilitators observed in conversation
Goal Attainment Score
时间窗: change from pre-treatment to post-treatment (approximately 9-11 weeks after treatment onset) and follow-ups at 3 months post-treatment
The Goal Attainment Score measures self-reported progress on personalized goals based on a five point scale, with higher values indicating better goal attainment. The minimum score is -2 (much less than expected) and the maximum score is +2 (much more than expected).
次要结局
- Change on Quick Aphasia Battery(change from pre-treatment or waitlist to post-treatment or waitlist (12-13 weeks), and follow-up at 3 months post-treatment)
- Change on Aphasia Impact Questionnaire(change from pre-treatment or waitlist to post-treatment or waitlist (12-13 weeks), and follow-up at 3 months post-treatment)
- Acceptability and Perception of Change Survey(post-treatment (approximately 12-13 weeks after treatment onset))
- Change on Adult Carers Quality of Life Questionnaire(change from pre-treatment or waitlist to post-treatment or waitlist (12-13 weeks), and follow-up at 3 months post-treatment)
- Change on Brief - Coping Orientation to Problems Experienced Inventory (Brief-COPE)(change from pre-treatment or waitlist to post-treatment or waitlist (12-13 weeks), and follow-up at 3 months post-treatment)
- Change on Quick Aphasia Battery(change from pre-treatment to post-treatment (approximately 9-11 weeks after treatment onset) and follow-ups at 3 months post-treatment)
- Change on Aphasia Impact Questionnaire(change from pre-treatment to post-treatment (approximately 9-11 weeks after treatment onset) and follow-ups at 3 months post-treatment)
- Change on Adult Carers Quality of Life Questionnaire(change from pre-treatment to post-treatment (approximately 9-11 weeks after treatment onset) and follow-ups at 3 months post-treatment)
- Change on Brief - Coping Orientation to Problems Experienced Inventory (Brief-COPE)(change from pre-treatment to post-treatment (approximately 9-11 weeks after treatment onset) and follow-ups at 3 months post-treatment)
研究者
Maya Henry
Associate Professor, Associate Dean for Research
University of Texas at Austin