Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06511752
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-06
Brief Title:
Educational Support Group Program for Bilingual and Spanish-speaking Carepartners and People With Progressive Aphasia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Educational Support Group Program for Carepartners of Bilingual and Spanish-speaking Persons With Progressive Forms of Aphasia and for Persons With Progressive Forms of Aphasia
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The current study aims to examine the benefits of an educationsupport group program for individuals with progressive aphasia caused by various etiologies diagnoses and their carepartners The current study utilizes pre- post-treatment and follow-up assessments to measure effects of a psychoeducational support group and an implementationcommunication skills training phase on measures of psychosocial function communicative effectiveness and speechlanguage function Analysis of study-specific surveys and semi-structured interviews will provide qualitative data regarding outcomes Before beginning the education and support group focus groups will be run in order to set priorities for the themes to be included in the education program Participants will join via tele-based means if preferred and these participants may reside in the United States or internationally including Mexico and Spain
Detailed Description:
Two educationalsupport group routes will be offered
1 Progressive aphasia PA educationalsupport group or
2 Caregiver educational support group with an implementation phase including their partner with PA
The caregiver educational support group path will be delivered in two phases whereas the PA educational support group path will only consist of the first phase The first phase of the caregiver educational support group will focus on the educational support group and the second phase will consist of implementation and practice of strategies with feedback provided by the clinician
The educationalsupport groups Routes 1 and 2 will include opportunities for discussion of issues related to language-led dementia or progressive aphasia eg coping with changes in cognition and language use of strategies for effective communication and education regarding the disorder provided by relevant experts eg speech-language pathologists licensed professional counselors separately for carepartners and individuals with progressive aphasia
The implementation phase Route 2 only will allow for practice of strategies and skills learned in the first phase
The total amount of time participants will be involved in the study will be 8 months inclusive of follow-up
Phase 1 Timeline for the support group portion of the study Participants will complete pre-treatment measures during a period of 1-2 weeks prior to their first meeting After four months of twice monthly meetings post-treatment measures will be completed within 1-2 weeks of treatment completion Follow-up evaluation will take place at 2-months post-treatment
Phase 2 Timeline for the implementationdyad training portion of the study Post-treatment assessment from Phase 1 will serve as pre-treatment assessment for Phase 2 Treatment sessions will be held once weekly for 4 weeks and post-treatment assessment will be completed within 1-2 weeks of phase 2 treatment completion Follow-up evaluation will take place at 2-months post-treatment
1 Progressive aphasia PA educationalsupport group or
2 Caregiver educational support group with an implementation phase including their partner with PA
The caregiver educational support group path will be delivered in two phases whereas the PA educational support group path will only consist of the first phase The first phase of the caregiver educational support group will focus on the educational support group and the second phase will consist of implementation and practice of strategies with feedback provided by the clinician
The educationalsupport groups Routes 1 and 2 will include opportunities for discussion of issues related to language-led dementia or progressive aphasia eg coping with changes in cognition and language use of strategies for effective communication and education regarding the disorder provided by relevant experts eg speech-language pathologists licensed professional counselors separately for carepartners and individuals with progressive aphasia
The implementation phase Route 2 only will allow for practice of strategies and skills learned in the first phase
The total amount of time participants will be involved in the study will be 8 months inclusive of follow-up
Phase 1 Timeline for the support group portion of the study Participants will complete pre-treatment measures during a period of 1-2 weeks prior to their first meeting After four months of twice monthly meetings post-treatment measures will be completed within 1-2 weeks of treatment completion Follow-up evaluation will take place at 2-months post-treatment
Phase 2 Timeline for the implementationdyad training portion of the study Post-treatment assessment from Phase 1 will serve as pre-treatment assessment for Phase 2 Treatment sessions will be held once weekly for 4 weeks and post-treatment assessment will be completed within 1-2 weeks of phase 2 treatment completion Follow-up evaluation will take place at 2-months post-treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None