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

NCT03621397 | Withdrawn DMC

• 1 other identifier: 1222300-1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Subarachnoid Hemorrhage; Cognitive Impairment; Quality of Life; Depression, Anxiety

Keywords

Spanish-speakers; Subarachnoid hemorrhage; Cognitive Intervention

Outcome Measures

Primary Outcomes (6)

• Spanish Rey Auditory Verbal Learning Test

  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.

  16 months

• Escala Wechsler de Inteligencia Para Adultos-IV (WAIS-IV; Wechsler, 2008) Retención de dígitos

  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.

  16 months

• Escala Wechsler de Inteligencia Para Adultos-IV (WAIS-IV) Claves subtest

  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.

  16 months

• Color Trails 1 and 2 (D'Elia, Satz, Lyons-Uchiyama, & White, 1996)

  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.

  16 months

• FAS (Lezak, 1995; Pontón et al., 1996; O'Bryant et al., 2017; Benton, Hamsher, & Sivan, 2000)

  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.

  16 months

• Animal Naming (Lezak, 1995; O'Bryant et al., 2017

  This is a measure of semantic fluency abilities. Participants are required to generate as many animal names within 60 seconds.

  16 months

Secondary Outcomes (4)

• Spanish SF-36 (Ware, 1992; Alonso, 1995; Ware, 2000)

  16 months

• Spanish Satisfaction with Life Questionnaire (Diener, Emmons, Larsen, & Griffin, 1985; Diener & Gonzalez, 2011; Vásquez, Duque, & Hervás, 2013)

  16 months

• Spanish Beck Depression Inventory-Second Edition (Beck, Steer, & Brown, 1996)

  16 months

• Spanish Beck Anxiety Inventory (Beck & Steer, 1993)

  16 months

Other Outcomes (5)

• Spanish Marín Acculturation Scale (Marín et al., 1987)

  One week

• Escala Wechsler de Inteligencia Para Adultos-IV (WAIS-IV) Vocabulario subtest

  One week

• Woodcock-Johnson III/Batería III Pruebas de aprovechamiento (Mather & Woodcock, 2005): Identificación de letras y palabras subtest:

  One week

Study Arms (2)

Cognitive Intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

brainHQ by Posit Science DEVICE

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.

Cognitive Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• DHR Health Institute for Research and Development: lead

Study Sites (1)

DHR Health Neuroscience Institute

Edinburg, Texas, 78539, United States

Location

Related Publications (29)

• Alonso J, Prieto L, Anto JM. [The Spanish version of the SF-36 Health Survey (the SF-36 health questionnaire): an instrument for measuring clinical results]. Med Clin (Barc). 1995 May 27;104(20):771-6. Spanish.

  PMID: 7783470 BACKGROUND

• Beck, AT, Steer, RA. Beck Anxiety Inventory. San Antonio, TX: Psychological Corporation, 1993.

  BACKGROUND

• Beck AT, Steer RA, Brown GK. Beck Depression Inventory-II. San Antonio, TX: Psychological Corporation, 1996.

  BACKGROUND

• Benton A L, Hamsher K, Sivan A. Multilingual Aphasia Examination: Manual. Iowa City, IA: AJA Associates Inc, 2000.

  BACKGROUND

• brainHQ from Posit Science (https://es.brainhq.com/).

  BACKGROUND

• D'Elia LF, Satz P, Lyons-Uchiyama C, White T. Color Trails Test Professional Manual. Lutz, FL: PAR, 1996.

  BACKGROUND

• Lezak MD. Neuropsychological assessment (3rd ed.). New York, NY US: Oxford University Press, 1995.

  BACKGROUND

• 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.

  BACKGROUND

• Mather N, Woodcock RW. Manual de examinador (L.Wolfson, Trans). Woodcock-Johnson III Pruebas de aprovechamiento. Rolling Meadows, IL: Riverside, 2005.

  BACKGROUND

• O'Bryant SE, Edwards M, Johnson L, Hall J, Gamboa A, O'jile J. Texas Mexican American adult normative studies: Normative data for commonly used clinical neuropsychological measures for English- and Spanish-speakers. Dev Neuropsychol. 2018 Jan;43(1):1-26. doi: 10.1080/87565641.2017.1401628. Epub 2017 Nov 30.

  PMID: 29190120 BACKGROUND

• Ponton MO, Satz P, Herrera L, Ortiz F, Urrutia CP, Young R, D'Elia LF, Furst CJ, Namerow N. Normative data stratified by age and education for the Neuropsychological Screening Battery for Hispanics (NeSBHIS): Initial report. J Int Neuropsychol Soc. 1996 Mar;2(2):96-104. doi: 10.1017/s1355617700000941.

  PMID: 9375194 BACKGROUND

• Rey A. L 'examen clinique en psychologie [Clinical tests in psychology]. Presses Universitaires de France, Paris, 1964.

  BACKGROUND

• Schmidt M. Rey Auditory and Verbal Learning Test: a handbook. Los Angeles, CA: Western Psychological Services, 1996.

  BACKGROUND

• Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.

  PMID: 1593914 BACKGROUND

• Ware JE Jr. SF-36 health survey update. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3130-9. doi: 10.1097/00007632-200012150-00008. No abstract available.

  PMID: 11124729 BACKGROUND

• Wechsler D. Wechsler Adult Intelligence Scale-Fourth Edition. San Antonio, TX: The Psychological Corporation, 2008.

  BACKGROUND

• Wechsler D. Escala Wechsler de Inteligencia Para Adultos-IV. México D.F.: Editorial El Manual Moderno, NCS Pearson Inc, 2008.

  BACKGROUND

• Wilkinson G, Robertson G. Wide range achievement test-fourth edition. Lutz, FL: Psychological Assessment Resources, Inc: 2006.

  BACKGROUND

• Appelbaum PS, Grisso T. Assessing patients' capacities to consent to treatment. N Engl J Med. 1988 Dec 22;319(25):1635-8. doi: 10.1056/NEJM198812223192504.

  PMID: 3200278 RESULT

• Barnes DE, Yaffe K, Belfor N, Jagust WJ, DeCarli C, Reed BR, Kramer JH. Computer-based cognitive training for mild cognitive impairment: results from a pilot randomized, controlled trial. Alzheimer Dis Assoc Disord. 2009 Jul-Sep;23(3):205-10. doi: 10.1097/WAD.0b013e31819c6137.

  PMID: 19812460 RESULT

• Dreer LE, Devivo MJ, Novack TA, Krzywanski S, Marson DC. Cognitive Predictors of Medical Decision-Making Capacity in Traumatic Brain Injury. Rehabil Psychol. 2008 Nov 1;53(4):486-497. doi: 10.1037/a0013798.

  PMID: 20686627 RESULT

• Egeto P, Loch Macdonald R, Ornstein TJ, Schweizer TA. Neuropsychological function after endovascular and neurosurgical treatment of subarachnoid hemorrhage: a systematic review and meta-analysis. J Neurosurg. 2018 Mar;128(3):768-776. doi: 10.3171/2016.11.JNS162055. Epub 2017 Apr 14.

  PMID: 28409729 RESULT

• Estevis E, Basso MR, Combs D. Effects of practice on the Wechsler Adult Intelligence Scale-IV across 3- and 6-month intervals. Clin Neuropsychol. 2012;26(2):239-54. doi: 10.1080/13854046.2012.659219. Epub 2012 Feb 21.

  PMID: 22353021 RESULT

• Fernandez-Calvo B, Rodriguez-Perez R, Contador I, Rubio-Santorum A, Ramos F. [Efficacy of cognitive training programs based on new software technologies in patients with Alzheimer-type dementia]. Psicothema. 2011 Feb;23(1):44-50. Spanish.

  PMID: 21266141 RESULT

• Kesler S, Hadi Hosseini SM, Heckler C, Janelsins M, Palesh O, Mustian K, Morrow G. Cognitive training for improving executive function in chemotherapy-treated breast cancer survivors. Clin Breast Cancer. 2013 Aug;13(4):299-306. doi: 10.1016/j.clbc.2013.02.004. Epub 2013 May 4.

  PMID: 23647804 RESULT

• Latimer SF, Wilson FC, McCusker CG, Caldwell SB, Rennie I. Subarachnoid haemorrhage (SAH): long-term cognitive outcome in patients treated with surgical clipping or endovascular coiling. Disabil Rehabil. 2013 May;35(10):845-50. doi: 10.3109/09638288.2012.709909. Epub 2012 Aug 22.

  PMID: 22909316 RESULT

• 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.

  RESULT

• Penner IK, Vogt A, Stocklin M, Gschwind L, Opwis K, Calabrese P. Computerised working memory training in healthy adults: a comparison of two different training schedules. Neuropsychol Rehabil. 2012;22(5):716-33. doi: 10.1080/09602011.2012.686883. Epub 2012 Jun 6.

  PMID: 22671966 RESULT

• Westerberg H, Jacobaeus H, Hirvikoski T, Clevberger P, Ostensson ML, Bartfai A, Klingberg T. Computerized working memory training after stroke--a pilot study. Brain Inj. 2007 Jan;21(1):21-9. doi: 10.1080/02699050601148726.

  PMID: 17364516 RESULT

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Cognitive Dysfunction; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Eduardo Estevis, Ph.D.

  DHR Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Neuropsychologist

Model Details: 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.

Study Record Dates

• First Submitted: July 31, 2018
• First Posted: August 8, 2018
• Study Start: December 1, 2021
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: January 18, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)