Educational Support Group Program for Bilingual and Spanish-speaking Carepartners and People With… (NCT06511752) | Clinical Trial Compass
RecruitingEarly Phase 1
Educational Support Group Program for Bilingual and Spanish-speaking Carepartners and People With Progressive Aphasia
United States120 participantsStarted 2024-05-21
Plain-language summary
The current study aims to examine the benefits of an education/support 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 implementation/communication skills training phase on measures of psychosocial function, communicative effectiveness and speech/language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
All participants must:
* speak Spanish and/or English (although participants may speak other languages in addition to Spanish and/or English)
* identify as Hispanic and/or Latinx,
* or their spouse/family member with PA identifies as Hispanic and/or Latinx
* see and hear well enough to participate
* have access to a computer or mobile device with video capability
* have an internet connection
Additional inclusion criteria for PA/ language-led dementia support group participants:
* Individuals with PA:
* Has a diagnosis of PA, or language-led dementia, and aphasia is one of the primary causes of difficulty with activities of daily living
* Aware of language difficulties and willing to discuss them
* Able to actively engage in group discussion and complete activities with minimal support
* Able to regularly attend meetings
* Willing to follow the rules of the support group for interacting with others respectfully
Additional inclusion criteria for care partner support group plus implementation phase participants:
* Individuals with PA:
* Diagnosis of aphasia or dementia that is progressive in nature, and aphasia is one of the primary causes of difficulty with activities of daily living
* Have some ability to communicate and understand communication in order to participate in training sessions
* Are functionally able to engage in training sessions (e.g., able to maintain some attention, minimal challenging behavior that would cause disruption)
* Have a c…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is focused specifically on bilingual and Spanish-speaking caregivers and people with progressive aphasia — does my family member's language background and type of aphasia actually match what this study is looking for?
2Since this is an Early Phase 1 study, it seems like researchers are still figuring out whether the program is acceptable and usable rather than proving it works — what does that mean for what my family member and I would actually get out of participating?
3The main thing being measured is a survey about whether the support group program feels acceptable to participants, so how would joining this trial compare to getting established caregiver support services that already exist in Spanish?
4Progressive aphasia can make communication really difficult over time — how would my family member's current ability to communicate affect whether they could meaningfully participate in a group education program like this?
5Given that this trial is still in very early stages and is recruiting now, would it make more sense for us to focus first on standard care and existing Spanish-language resources, or is there a reason to consider this trial at this point in our situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Treatment/Acceptability Survey
Timeframe: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment