Clinical trial NCT03621397: Online Spanish Cognitive Intervention Program for Spanish-Speaking Latino/Hispanic Subarachnoid Hemorrhage Patients
Official title: The Effectiveness of an Online Spanish Cognitive Intervention Program for Spanish-Speaking Latino/Hispanic Subarachnoid Hemorrhage Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Subarachnoid Hemorrhage
Cognitive Impairment
Quality of Life
Depression, Anxiety
Keywords: Spanish-speakers
Subarachnoid hemorrhage
Cognitive Intervention
Lead sponsor: DHR Health Institute for Research and Development
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 40 Spanish-speaking research participants who have sustained a subarachnoid hemorrhage in the last 6 months will participate in the research study. Participants will be randomly assigned to one of two groups: 1) Cognitive intervention group (n = 20) or 2) Control group (n = 20). The Cognitive Intervention group will receive the cognitive intervention, while the Control group will not receive any intervention.
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to examine the effectiveness of an online Spanish cognitive intervention program in Latino/Hispanic Spanish-speaking subarachnoid hemorrhage patients. In particular, the researchers will examine whether cognitive impairments associated with a subarachnoid hemorrhagic event improve after completing the online cognitive intervention program. Secondary outcomes of the research study include examining whether there is an improvement in research participants' quality of life and psychological functioning as a result of the online Spanish cognitive intervention program.

Detailed description: 40 Spanish-speaking research participants who have sustained a subarachnoid hemorrhage in the last 6 months will participate in the current research study. Participants will be randomly assigned to one of two groups: 1) Cognitive intervention group (n = 20) or 2) Control group (n = 20).

Eligibility criteria: Inclusion Criteria:

* History of a subarachnoid hemorrhage within the last 6-months. Must be confirmed by medical records and/or neurointerventionist radiologist
* 18 years and older
* Primarily Spanish-Speaking
* Able to read in Spanish
* Able to use a computer

Exclusion Criteria:

* History of neurological conditions (e.g., Alzheimer's disease, epilepsy, traumatic brain injury, brain tumor, encephalitis, meningitis, Parkinson's disease) other than subarachnoid hemorrhage
* History of neurodevelopment disorder (e.g., autism spectrum disorders, attention deficit-hyperactivity disorder)
* History of learning disabilities
* History of psychiatric illness (e.g., depression, anxiety, bipolar disorder, schizophrenia)
* Alcohol or illicit substance abuse or dependence
* Currently on medication(s) that may impact performance on the neuropsychological evaluation or online cognitive intervention program
* Severe expressive aphasia
* Upper extremities or vision problems that prevent participant from adequately using a computer or completing the neuropsychological evaluation
* Unable to commit to participate for the entire study including returning for one-year follow-up neuropsychological evaluation

Primary outcomes:
measure: Spanish Rey Auditory Verbal Learning Test
timeFrame: 16 months
measure: Escala Wechsler de Inteligencia Para Adultos-IV (WAIS-IV; Wechsler, 2008) Retención de dígitos
timeFrame: 16 months
measure: Escala Wechsler de Inteligencia Para Adultos-IV (WAIS-IV) Claves subtest
timeFrame: 16 months
measure: Color Trails 1 and 2 (D'Elia, Satz, Lyons-Uchiyama, & White, 1996)
timeFrame: 16 months
measure: FAS (Lezak, 1995; Pontón et al., 1996; O'Bryant et al., 2017; Benton, Hamsher, & Sivan, 2000)
timeFrame: 16 months
measure: Animal Naming (Lezak, 1995; O'Bryant et al., 2017
timeFrame: 16 months
Secondary outcomes:
measure: Spanish SF-36 (Ware, 1992; Alonso, 1995; Ware, 2000)
timeFrame: 16 months
measure: Spanish Satisfaction with Life Questionnaire (Diener, Emmons, Larsen, & Griffin, 1985; Diener & Gonzalez, 2011; Vásquez, Duque, & Hervás, 2013)
timeFrame: 16 months
measure: Spanish Beck Depression Inventory-Second Edition (Beck, Steer, & Brown, 1996)
timeFrame: 16 months
measure: Spanish Beck Anxiety Inventory (Beck & Steer, 1993)
timeFrame: 16 months
Other outcomes:
measure: Spanish Marín Acculturation Scale (Marín et al., 1987)
timeFrame: One week
measure: Escala Wechsler de Inteligencia Para Adultos-IV (WAIS-IV) Vocabulario subtest
timeFrame: One week
measure: Woodcock-Johnson III/Batería III Pruebas de aprovechamiento (Mather & Woodcock, 2005): Identificación de letras y palabras subtest:
timeFrame: One week
measure: Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV; Wechsler, 2008) Vocabulary subtest
timeFrame: One week
measure: Wide Range Achievement Test-Fourth Edition (WRAT-4; Wilkson & Robertson, 2006) Reading subtest
timeFrame: One week
Locations:
city: Edinburg
country: United States
facility: DHR Health Neuroscience Institute
state: Texas
Study officials:
affiliation: DHR Health
name: Eduardo Estevis, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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