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Online Spanish Cognitive Intervention Program for Spanish-Speaking Latino/Hispanic Subarachnoid Hemorrhage Patients

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ClinicalTrials.gov Identifier: NCT03621397
Recruitment Status : Recruiting
First Posted : August 8, 2018
Last Update Posted : November 1, 2019
Sponsor:
Information provided by (Responsible Party):
Eduardo Estevis, Doctors Hospital at Renaissance

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.

Condition or disease Intervention/treatment Phase
Subarachnoid Hemorrhage Cognitive Impairment Quality of Life Depression, Anxiety Device: brainHQ by Posit Science Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effectiveness of an Online Spanish Cognitive Intervention Program for Spanish-Speaking Latino/Hispanic Subarachnoid Hemorrhage Patients
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: Cognitive Intervention Group
Research participants in the cognitive intervention group will undergo a baseline neuropsychological evaluation. One week later, they will receive the online training program (brainHQ by Posit Science) three times a week for 45 minutes for a total of 12 weeks. This group will return one week after completing the online intervention program for their follow-up neuropsychological evaluation. They will then return again one year later for another follow-up neuropsychological evaluation.
Device: brainHQ by Posit Science
This is an online cognitive training program. It consists of 29 online exercises that work out attention, brain speed, memory, people skills, navigation, and intelligence. The current study will focus on the following exercises: attention, brain speed (e.g., processing speed), executive function, and memory.

No Intervention: Control Group
Research participants in the control group will undergo a baseline neuropsychological evaluation. They will then return 13 weeks after their baseline neuropsychological evaluation for a follow-up neuropsychological evaluation and again one year later.



Primary Outcome Measures :
  1. Spanish Rey Auditory Verbal Learning Test [ Time Frame: 16 months ]
    This is a commonly used comprehensive verbal learning and memory test. The test consists of a 15-item word list that is presented five times. Participants are then asked to recall as many words following a brief delay and 20 minutes later. Raw scores from the following scales will be utilized: Total Recall, Short-Delayed Free Recall, Long-Delayed Free Recall, and Recognition Hits. Score values range from 0-to-15. These are considered participants' raw scores. Raw scores will then be converted to scaled scores based on available published normative data. All converted scores will be presented as scaled scores with a mean of ten and standard deviation of three in order to ensure that all scores are on a uniform scale. Scores falling at 1.5 standard deviations below the mean (scaled score ≤ 5) will be considered impaired. Scores that are above the 1.5 cut-off (scaled score ≥ 6) will be considered to be intact. Intact scores will be indicative of better memory outcomes.

  2. Escala Wechsler de Inteligencia Para Adultos-IV (WAIS-IV; Wechsler, 2008) Retención de dígitos [ Time Frame: 16 months ]
    This is an oral measure of working memory and attention abilities. Participants are presented with a series of numbers and must repeat them correctly in forward, reverse, and sequence order. Score values range from 0-to-48. These are considered participants' raw scores. Raw scores will then be converted to scaled scores based on available published normative data. All converted scores will be presented as scaled scores with a mean of ten and standard deviation of three in order to ensure that all scores are on a uniform scale. Scores falling at 1.5 standard deviations below the mean (scaled score ≤ 5) will be considered impaired. Scores that are above the 1.5 cut-off (scaled score ≥ 6) will be considered to be intact. Intact scores will be indicative of better outcomes on working memory and attentional abilities.

  3. Escala Wechsler de Inteligencia Para Adultos-IV (WAIS-IV) Claves subtest [ Time Frame: 16 months ]
    This is speeded graphomotor transcription subtest that assesses attention and processing speed abilities. Participants are required to a place a code with its designated number as quickly as possible in 120 seconds. Score values range from 0-to-135. These are considered participants' raw scores. Raw scores will then be converted to scaled scores based on available published normative data. All converted scores will be presented as scaled scores with a mean of ten and standard deviation of three in order to ensure that all scores are on a uniform scale. Scores falling at 1.5 standard deviations below the mean (scaled score ≤ 5) will be considered impaired. Scores that are above the 1.5 cut-off (scaled score ≥ 6) will be considered to be intact. Intact scores will be indicative of better outcomes on processing speed and attentional abilities.

  4. Color Trails 1 and 2 (D'Elia, Satz, Lyons-Uchiyama, & White, 1996) [ Time Frame: 16 months ]
    These two tests are non-verbal timed measures that assess processing speed and executive functioning abilities. Color Trails 1 is a sequencing test in which participants draw a line connecting numbers scattered throughout the test stimuli from least to greatest as quickly as possible. In Color Trails 2, participants are required to do the same as in Color Trails 1, but they must alternate colors for each number sequence as quickly as possible.

  5. FAS (Lezak, 1995; Pontón et al., 1996; O'Bryant et al., 2017; Benton, Hamsher, & Sivan, 2000) [ Time Frame: 16 months ]
    This is a measure of lexical fluency abilities. Participants are required to generate as many words as possible within 60 seconds with the letters F, A, and S.

  6. Animal Naming (Lezak, 1995; O'Bryant et al., 2017 [ Time Frame: 16 months ]
    This is a measure of semantic fluency abilities. Participants are required to generate as many animal names within 60 seconds.


Secondary Outcome Measures :
  1. Spanish SF-36 (Ware, 1992; Alonso, 1995; Ware, 2000) [ Time Frame: 16 months ]
    This is a 36-item quality of life measure. The 36-itmes are related to various aspects of the participants' life which are rated on a Likert scale of 1-to-5. From these items, the following eight subscales are derived: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role function, and mental. Scores on the SF-36 range from 1-100 with higher scores being indicative of better quality of life outcomes.

  2. Spanish Satisfaction with Life Questionnaire (Diener, Emmons, Larsen, & Griffin, 1985; Diener & Gonzalez, 2011; Vásquez, Duque, & Hervás, 2013) [ Time Frame: 16 months ]
    This is a 5-item questionnaire that assesses life satisfaction. These five items consist of Likert-scale responses that range from 1-7. Total scores on this measure range from 1-35 with higher scores being indicative of better life satisfaction outcomes.

  3. Spanish Beck Depression Inventory-Second Edition (Beck, Steer, & Brown, 1996) [ Time Frame: 16 months ]
    This is a 21-item depression self-report measure. These items consist of Likert-scale responses that range from 0-3 with lower scores being indicative of less depressive symptomology. Total scores range from 0-63. Cut-offs for depression severity is based on available published cut-off scores and includes the following ranges: minimal (0-13), mild (14-19), moderate (20-28), and severe (29-63). Participants who obtain classifications in the minimal range will be indicative of better psychological functioning outcomes. Participants who have scores in the moderate and severe range will be indicative of worse psychological functioning.

  4. Spanish Beck Anxiety Inventory (Beck & Steer, 1993) [ Time Frame: 16 months ]
    This is a 21-item anxiety self-report measure. These items consist of Likert-scale responses that range from 0-3 with lower scores being indicative of less anxiety. Total scores range from 0-63. Cut-offs for anxiety severity is based on available published cut-off scores and includes the following ranges: minimal (0-7), mild (8-15), moderate (16-25), and severe (26-63). Participants who obtain classifications in the minimal range will be indicative of better psychological functioning outcomes. Participants who have scores in the moderate and severe range will be indicative of worse psychological functioning.


Other Outcome Measures:
  1. Spanish Marín Acculturation Scale (Marín et al., 1987) [ Time Frame: One week ]
    This is a 13-item scale that assesses degree of acculturation. These items consist of 5-point Likert-scale responses with total scores ranging from 1-65. Low scores are suggestive of a low degree of acculturation and high scores are suggestive of a high degree of acculturation. This measure is not an outcome measure. It is use to establish level of acculturation. It will also be used in the data analysis to determine whether it impacts performance on cognitive measures.

  2. Escala Wechsler de Inteligencia Para Adultos-IV (WAIS-IV) Vocabulario subtest [ Time Frame: One week ]
    This is a Spanish oral measure of expressive vocabulary abilities. Participants are required to define words presented to them visually and orally. Score values range from 0-to-57. These are considered participants' raw scores. Raw scores will then be converted to scaled scores based on available published normative data. All converted scores will be presented as scaled scores with a mean of ten and standard deviation of three in order to ensure that all scores are on a uniform scale. Scores falling at 1.5 standard deviations below the mean (scaled score ≤ 5) will be considered impaired. Scores that are above the 1.5 cut-off (scaled score ≥ 6) will be considered to be intact. Intact scores will be indicative of participants' being Spanish-language dominant. This is not an outcome measure and only used to establish Spanish-language dominance.

  3. Woodcock-Johnson III/Batería III Pruebas de aprovechamiento (Mather & Woodcock, 2005): Identificación de letras y palabras subtest: [ Time Frame: One week ]
    This is a Spanish reading ability test. On this measure, participants are asked to name as many words as they can. This test initially begins with simple words and they increase in difficulty as the test progresses. Scores range from 1-76. These are considered participants' raw scores. Raw scores will then be converted to scaled scores based on available published normative data. All converted scores will be presented as scaled scores with a mean of ten and standard deviation of three in order to ensure that all scores are on a uniform scale. Scores falling at 1.5 standard deviations below the mean (scaled score ≤ 5) will be considered impaired. Scores that are above the 1.5 cut-off (scaled score ≥ 6) will be considered to be intact. Intact scores will be indicative of participants' being Spanish-language dominant. This is not an outcome measure and only used to establish Spanish-language dominance.

  4. Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV; Wechsler, 2008) Vocabulary subtest [ Time Frame: One week ]
    This is an English oral measure of expressive vocabulary abilities. Participants are required to define words presented to them visually and orally. Score values range from 0-to-57. These are considered participants' raw scores. Raw scores will then be converted to scaled scores based on available published normative data. All converted scores will be presented as scaled scores with a mean of ten and standard deviation of three in order to ensure that all scores are on a uniform scale. Scores falling at 1.5 standard deviations below the mean (scaled score ≤ 5) will be considered impaired. Scores that are above the 1.5 cut-off (scaled score ≥ 6) will be considered to be intact. Impaired scores will be indicative of participants' being Spanish-language dominant. This is not an outcome measure and is only being used to establish Spanish-language dominance.

  5. Wide Range Achievement Test-Fourth Edition (WRAT-4; Wilkson & Robertson, 2006) Reading subtest [ Time Frame: One week ]
    This is an English reading ability test. On this measure, participants are asked to name as many words as they can. This test initially begins with simple words and they increase in difficulty as the test progresses. Scores range from 0-70. These are considered participants' raw scores. Raw scores will then be converted to scaled scores based on available published normative data. All converted scores will be presented as scaled scores with a mean of ten and standard deviation of three in order to ensure that all scores are on a uniform scale. Scores falling at 1.5 standard deviations below the mean (scaled score ≤ 5) will be considered impaired. Scores that are above the 1.5 cut-off (scaled score ≥ 6) will be considered to be intact. Impaired scores will be indicative of participants' being Spanish-language dominant. This is not an outcome measure and is only being used to establish Spanish-language dominance.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03621397


Contacts
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Contact: Eduardo Estevis, Ph.D. 956-362-8507 e.estevis@dhr-rgv.com
Contact: Patrick T. Noonan, MD 956-362-8500 pt.noonan@dhr-rgv.com

Locations
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United States, Texas
DHR Health Neuroscience Institute Recruiting
Edinburg, Texas, United States, 78539
Contact: Eduardo Estevis, Ph.D.    956-362-8507    e.estevis@dhr-rgv.com   
Contact: Patrick T Noonan, MD    956-362-8500    pt.noonan@dhr-rgv.com   
Sponsors and Collaborators
Doctors Hospital at Renaissance
Investigators
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Principal Investigator: Eduardo Estevis, Ph.D. DHR Health

Publications of Results:
Marson DC, Strickland A, Hethcox A, DeVivo M, Taylor S, Krzywanski S, et al. Assessing competency to consent to treatment in traumatic brain injury. Paper presented at the 21st Annual Conference of the National Academy of Neuropsychology, San Francisco, California, 2001.

Other Publications:
Beck, AT, Steer, RA. Beck Anxiety Inventory. San Antonio, TX: Psychological Corporation, 1993.
Beck AT, Steer RA, Brown GK. Beck Depression Inventory-II. San Antonio, TX: Psychological Corporation, 1996.
Benton A L, Hamsher K, Sivan A. Multilingual Aphasia Examination: Manual. Iowa City, IA: AJA Associates Inc, 2000.
brainHQ from Posit Science (https://es.brainhq.com/).
D'Elia LF, Satz P, Lyons-Uchiyama C, White T. Color Trails Test Professional Manual. Lutz, FL: PAR, 1996.
Lezak MD. Neuropsychological assessment (3rd ed.). New York, NY US: Oxford University Press, 1995.
Marin G, Sabogal F, Otero-Sabogal R, Perez-Stable EJ. Development of a short acculturation scale for Hispanics. Hispanic Journal of Behavioral Sciences, 9, 183-205, 1987.
Mather N, Woodcock RW. Manual de examinador (L.Wolfson, Trans). Woodcock-Johnson III Pruebas de aprovechamiento. Rolling Meadows, IL: Riverside, 2005.
Rey A. L 'examen clinique en psychologie [Clinical tests in psychology]. Presses Universitaires de France, Paris, 1964.
Schmidt M. Rey Auditory and Verbal Learning Test: a handbook. Los Angeles, CA: Western Psychological Services, 1996.
Wechsler D. Wechsler Adult Intelligence Scale-Fourth Edition. San Antonio, TX: The Psychological Corporation, 2008.
Wechsler D. Escala Wechsler de Inteligencia Para Adultos-IV. México D.F.: Editorial El Manual Moderno, NCS Pearson Inc, 2008.
Wilkinson G, Robertson G. Wide range achievement test-fourth edition. Lutz, FL: Psychological Assessment Resources, Inc: 2006.

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Responsible Party: Eduardo Estevis, Clinical Neuropsychologist, Doctors Hospital at Renaissance
ClinicalTrials.gov Identifier: NCT03621397     History of Changes
Other Study ID Numbers: 1222300-1
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eduardo Estevis, Doctors Hospital at Renaissance:
Spanish-speakers
Subarachnoid hemorrhage
Cognitive Intervention
Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Hemorrhage
Cognitive Dysfunction
Pathologic Processes
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases