MedPath

Educational Support Group Program for Bilingual and Spanish-speaking Carepartners and People With Progressive Aphasia

Early Phase 1
Recruiting
Conditions
Progressive Aphasia
Dementia
Aphasia
Alzheimer Disease
Primary Progressive Aphasia
Progressive Aphasia in Alzheimer's Disease
Interventions
Behavioral: Psychosocial educational, support group and implementation of strategies
Registration Number
NCT06511752
Lead Sponsor
University of Texas at Austin
Brief 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.

Detailed Description

Two educational/support group routes will be offered:

1. Progressive aphasia (PA) educational/support 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 educational/support groups (Routes 1 and 2) will include opportunities for discussion of issues related to language-led dementia or progressive aphasia (e.g., coping with changes in cognition and language, use of strategies for effective communication) and education regarding the disorder provided by relevant experts (e.g., 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 9 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 3-months post-treatment.

Phase 2. Timeline for the implementation/dyad 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 3-months post-treatment.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
120
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 care partner who also consents to participating in the project
  • Care partners:
  • Self-identification as a caregiver of an individual with a diagnosis of PA or language-led dementia
  • Willing to discuss caregiving for individuals with PA/ language-led dementia
  • Able to regularly attend meetings
  • Willing to follow the rules of the support group for interacting with others respectfully
Exclusion Criteria

• Beyond the inclusion criteria included above, no additional exclusion criteria apply

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Treatment ConditionPsychosocial educational, support group and implementation of strategiesSupport group meetings and strategy practice
Primary Outcome Measures
NameTimeMethod
Treatment/Acceptability SurveyBaseline, Immediately following treatment, Follow-up at 3-months post-treatment

In-house Acceptability and Perception of Change Survey

Secondary Outcome Measures
NameTimeMethod
Acceptability MeasureBaseline, Immediately following treatment, Follow-up at 3-months post-treatment

Acceptability scale for healthcare interventions (the Theoretical Framework of Acceptability based questionnaire; Sekhon et al., 2022)

% participants who complete intervention, % sessions completedBaseline, Immediately following treatment, Follow-up at 3-months post-treatment

Adherence/receipt of intervention, 0-100, greater better

% completion of homeworkBaseline, Immediately following treatment, Follow-up at 3-months post-treatment

Engagement, 0-100, greater better

RetentionBaseline, Immediately following treatment, Follow-up at 3-months post-treatment

Number of dropouts, reasons for dropout (related to intervention or not), and overall, retention rate at final assessment and follow-up; 80% is successful at the final post-treatment assessment and 80% is successful at the 2-month follow-up, 0-100, greater better

Aphasia Impact QuestionnaireBaseline, Immediately following treatment, Follow-up at 3-months post-treatment

Aphasia impact, Higher score indicates poorer quality of life (worse) Range of scores for each question: 0-4 Total 0-84

Mini-Mental State ExamBaseline, Immediately following treatment, Follow-up at 3-months post-treatment

Cognitive screener, 0-30, greater better

Quick Aphasia BatteryBaseline, Immediately following treatment, Follow-up at 3-months post-treatment

Aphasia severity, 0-10, greater better

Stroke and Aphasia Quality of Life Scale- 39Baseline, Immediately following treatment, Follow-up at 3-months post-treatment

Quality of life, greater score is better, 0-195

Progressive Aphasia Severity Scale (PASS)Baseline, Immediately following treatment, Follow-up at 3-months post-treatment

Aphasia severity, higher score = worse, 0-3

The Neuropsychiatric InventoryBaseline, Immediately following treatment, Follow-up at 3-months post-treatment

Neuropsychiatric status, higher score = worse, 0-36

Clinical Dementia Rating Scale (CDR)Baseline, Immediately following treatment, Follow-up at 3-months post-treatment

Dementia Rating, higher score = worse, 0-3

Quality of the Caregiver Patient Relationship (QCPR)Baseline, Immediately following treatment, Follow-up at 3-months post-treatment

Quality of life, higher scores is better,14-70

Dementia Quality of LifeBaseline, Immediately following treatment, Follow-up at 3-months post-treatment

Quality of life, higher score is better, 28-112

Geriatric Depression ScaleBaseline, Immediately following treatment, Follow-up at 3-months post-treatment

Depression, higher score is worse, 0-15

Dementia Knowledge Assessment ScaleBaseline, Immediately following treatment, Follow-up at 3-months post-treatment

Dementia Knowledge, higher score is better, 0-60

Center for Epidemiologic Studies Depression ScaleBaseline, Immediately following treatment, Follow-up at 3-months post-treatment

Depression, higher score is worse, 0- 60

Cuestionario de Salud 36-Item Short Form Survey InstrumentBaseline, Immediately following treatment, Follow-up at 3-months post-treatment

General health, higher score is better, 0-100

General Anxiety Disorder-7Baseline, Immediately following treatment, Follow-up at 3-months post-treatment

Anxiety, higher score is worse, 0-21

The Duke University Religion IndexBaseline, Immediately following treatment, Follow-up at 3-months post-treatment

Religion Index

Familism ScaleBaseline, Immediately following treatment, Follow-up at 3-months post-treatment

Familism Scale, higher score= greater religiosity, 1-15 considering all subscales

Acculturation Rating Scale for Mexican AmericansBaseline, Immediately following treatment, Follow-up at 3-months post-treatment

Acculturation, higher score is better, 20-124

Adult Carer Quality of Life QuestionnaireBaseline, Immediately following treatment, Follow-up at 3-months post-treatment

Quality of Life, higher score is better, 0 -105

Brief COPEBaseline, Immediately following treatment, Follow-up at 3-months post-treatment

Coping strategies, higher score is better, 0-6

Brief Assessment Scale for CaregiversBaseline, Immediately following treatment, Follow-up at 3-months post-treatment

Coping strategies, higher score = worse, -28-28

Zarit Burden InterviewBaseline, Immediately following treatment, Follow-up at 3-months post-treatment

Burden, higher score = worse, 0-88

Perceived Stress ScaleBaseline, Immediately following treatment, Follow-up at 3-months post-treatment

Stress level, higher = worse, 0-40

Devereux Adult Resilience ScaleBaseline, Immediately following treatment, Follow-up at 3-months post-treatment

Resilience

Dementia Management Strategies Scale (Tan et al., 2013)Baseline, Immediately following treatment, Follow-up at 3-months post-treatment

Dementia management, higher score= higher frequency of action, subscales 8-55

Trial Locations

Locations (1)

University of Texas at Austin

🇺🇸

Austin, Texas, United States

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