Educational Support Group Program for Bilingual and Spanish-speaking Carepartners and People With Progressive Aphasia
NCT Number: NCT06511752
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Alzheimer Disease|Dementia|Primary Progressive Aphasia|Aphasia|Progressive Aphasia|Progressive Aphasia in Alzheimer's Disease
Interventions: BEHAVIORAL: Psychosocial educational, support group and implementation of strategies
Sponsor: University of Texas at Austin
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-21
Completion Date: 2030-12
Locations: University of Texas at Austin, Austin, Texas, 78702, United States

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.

Primary Outcome Measures: Treatment/Acceptability Survey, In-house Acceptability and Perception of Change Survey, Baseline, Immediately following treatment, Follow-up at 2-months post-treatment
Secondary Outcome Measures: Acceptability Measure, Acceptability scale for healthcare interventions (the Theoretical Framework of Acceptability based questionnaire; Sekhon et al., 2022), Baseline, Immediately following treatment, Follow-up at 2-months post-treatment|% participants who complete intervention, % sessions completed, Adherence/receipt of intervention, 0-100, greater better, Baseline, Immediately following treatment, Follow-up at 2-months post-treatment|% completion of homework, Engagement, 0-100, greater better, Baseline, Immediately following treatment, Follow-up at 2-months post-treatment|Retention, 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, Baseline, Immediately following treatment, Follow-up at 2-months post-treatment|Aphasia Impact Questionnaire, Aphasia impact, Higher score indicates poorer quality of life (worse) Range of scores for each question: 0-4 Total 0-84, Baseline, Immediately following treatment, Follow-up at 2-months post-treatment|Mini-Mental State Exam, Cognitive screener, 0-30, greater better, Baseline, Immediately following treatment, Follow-up at 2-months post-treatment|Quick Aphasia Battery, Aphasia severity, 0-10, greater better, Baseline, Immediately following treatment, Follow-up at 2-months post-treatment|Stroke and Aphasia Quality of Life Scale- 39, Quality of life, greater score is better, 0-195, Baseline, Immediately following treatment, Follow-up at 2-months post-treatment|Progressive Aphasia Severity Scale (PASS), Aphasia severity, higher score = worse, 0-3, Baseline, Immediately following treatment, Follow-up at 2-months post-treatment|The Neuropsychiatric Inventory, Neuropsychiatric status, higher score = worse, 0-36, Baseline, Immediately following treatment, Follow-up at 2-months post-treatment|Clinical Dementia Rating Scale (CDR), Dementia Rating, higher score = worse, 0-3, Baseline, Immediately following treatment, Follow-up at 2-months post-treatment|Quality of the Caregiver Patient Relationship (QCPR), Quality of life, higher scores is better,14-70, Baseline, Immediately following treatment, Follow-up at 2-months post-treatment|Dementia Quality of Life, Quality of life, higher score is better, 28-112, Baseline, Immediately following treatment, Follow-up at 2-months post-treatment|Geriatric Depression Scale, Depression, higher score is worse, 0-15, Baseline, Immediately following treatment, Follow-up at 2-months post-treatment|Dementia Knowledge Assessment Scale, Dementia Knowledge, higher score is better, 0-60, Baseline, Immediately following treatment, Follow-up at 2-months post-treatment|Center for Epidemiologic Studies Depression Scale, Depression, higher score is worse, 0- 60, Baseline, Immediately following treatment, Follow-up at 2-months post-treatment|Cuestionario de Salud 36-Item Short Form Survey Instrument, General health, higher score is better, 0-100, Baseline, Immediately following treatment, Follow-up at 2-months post-treatment|General Anxiety Disorder-7, Anxiety, higher score is worse, 0-21, Baseline, Immediately following treatment, Follow-up at 2-months post-treatment|The Duke University Religion Index, Religion Index, Baseline, Immediately following treatment, Follow-up at 2-months post-treatment|Familism Scale, Familism Scale, higher score= greater religiosity, 1-15 considering all subscales, Baseline, Immediately following treatment, Follow-up at 2-months post-treatment|Acculturation Rating Scale for Mexican Americans, Acculturation, higher score is better, 20-124, Baseline, Immediately following treatment, Follow-up at 2-months post-treatment|Adult Carer Quality of Life Questionnaire, Quality of Life, higher score is better, 0 -105, Baseline, Immediately following treatment, Follow-up at 2-months post-treatment|Brief COPE, Coping strategies, higher score is better, 0-6, Baseline, Immediately following treatment, Follow-up at 2-months post-treatment|Brief Assessment Scale for Caregivers, Coping strategies, higher score = worse, -28-28, Baseline, Immediately following treatment, Follow-up at 2-months post-treatment|Zarit Burden Interview, Burden, higher score = worse, 0-88, Baseline, Immediately following treatment, Follow-up at 2-months post-treatment|Perceived Stress Scale, Stress level, higher = worse, 0-40, Baseline, Immediately following treatment, Follow-up at 2-months post-treatment|Devereux Adult Resilience Scale, Resilience, Baseline, Immediately following treatment, Follow-up at 2-months post-treatment|Dementia Management Strategies Scale (Tan et al., 2013), Dementia management, higher score= higher frequency of action, subscales 8-55, Baseline, Immediately following treatment, Follow-up at 2-months post-treatment