Intervention for Communication Quality of Life in Primary Progressive Aphasia

Official title

Intervention to Promote Communication Quality of Life for Persons With Language-Led Dementia and Their Partners: A Randomized Pilot Trial

Overview

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.

Interventions

• Behavioral Multicomponent Lexical Retrieval Cascade Training
  In person or via teletherapy: A multi-component treatment incorporating elements of restitutive, compensatory, and care-partner focused interventions. Participants work on producing names of personally relevant targets in multiple communication modalities. Biweekly (45-90 minute) sessions with a clinician target multimodal communication and the use of strategies to support word retrieval. These skills are also trained via daily independent practice. The participant meets six times during the cou
• Behavioral Multicomponent Video Implemented Script Training in Aphasia
  In person or via teletherapy: A multi-component treatment incorporating elements of restitutive, compensatory, and care-partner focused interventions. Treatment focuses on production of individually-tailored, personally relevant scripts. The participant completes 30 minutes per day of independent practice, during which they speak in unison with a video model. Biweekly (45-90 minute) sessions with a clinician target clear and accurate script production, memorization, and conversational usage, as

Primary outcome measures

• Change in spoken naming of trained/untrained items [Time frame: change from pre-treatment or waitlist to post-treatment or waitlist (12-13 weeks), and follow-up at 3 months post-treatment]
• Change in script production accuracy [Time frame: change from pre-treatment or waitlist to post-treatment or waitlist (12-13 weeks), and follow-up at 3 months post-treatment]
• Change in barriers and facilitators in dyad conversation [Time frame: change from pre-treatment or waitlist to post-treatment or waitlist (12-13 weeks), and follow-up at 3 months post-treatment]
• Communication Modality Inventory [Time frame: change from pre-treatment or waitlist to post-treatment or waitlist (12-13 weeks), and follow-up at 3 months post-treatment]

Secondary outcome measures (5)

• Change on Quick Aphasia Battery [Time frame: 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 [Time frame: 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 [Time frame: post-treatment (approximately 12-13 weeks after treatment onset)]
• Change on Adult Carers Quality of Life Questionnaire [Time frame: 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) [Time frame: change from pre-treatment or waitlist to post-treatment or waitlist (12-13 weeks), and follow-up at 3 months post-treatment]

Eligibility criteria

Inclusion Criteria 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.

Exclusion criteria for persons with PPA:

• Other central nervous system or medical diagnosis that can account for symptoms
• Psychiatric diagnosis that can account for symptoms

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Texas — Austin

Publications

• Henry ML, Hubbard HI, Grasso SM, Mandelli ML, Wilson SM, Sathishkumar MT, Fridriksson J, Daigle W, Boxer AL, Miller BL, Gorno-Tempini ML. Retraining speech production and fluency in non-fluent/agrammatic primary progressive aphasia. Brain. 2018 Jun 1;141(6):1799-1814. doi: 10.1093/brain/awy101. PMID 29718131
• Henry ML, Hubbard HI, Grasso SM, Dial HR, Beeson PM, Miller BL, Gorno-Tempini ML. Treatment for Word Retrieval in Semantic and Logopenic Variants of Primary Progressive Aphasia: Immediate and Long-Term Outcomes. J Speech Lang Hear Res. 2019 Aug 15;62(8):2723-2749. doi: 10.1044/2018_JSLHR-L-18-0144. Epub 2019 Aug 7. PMID 31390290
• Dial HR, Hinshelwood HA, Grasso SM, Hubbard HI, Gorno-Tempini ML, Henry ML. Investigating the utility of teletherapy in individuals with primary progressive aphasia. Clin Interv Aging. 2019 Feb 25;14:453-471. doi: 10.2147/CIA.S178878. eCollection 2019. PMID 30880927

Identifiers

NCT: NCT07219680 · R61AG089318

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗