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Subarachnoid HemorrhageNCT03621397

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

A study testing brainHQ by Posit Science in people with Subarachnoid Hemorrhage and Cognitive Impairment, run by DHR Health Institute for Research and Development at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
brainHQ by Posit Science
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Dec 2021to Aug 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • DHR Health Neuroscience Institute

    Edinburg, Texas, 78539

Other trials in United States

About this study

Official title: The Effectiveness of an Online Spanish Cognitive Intervention Program for Spanish-Speaking Latino/Hispanic Subarachnoid Hemorrhage Patients

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.

Read the 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).

Being tested
brainHQ by Posit Science
Keywords
Spanish-speakers, Subarachnoid hemorrhage, Cognitive Intervention
Medical subject headings
Subarachnoid Hemorrhage, Cognitive Dysfunction, Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • brainHQ by Posit ScienceDevice

    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.

Study groups in NCT03621397
Study groupRoleWhat they receive
Cognitive Intervention GroupExperimentalResearch 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.
Receives: Device: brainHQ by Posit Science
Control GroupNo interventionResearch 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 16 months

  2. 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.

    Measured: 16 months

  3. 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.

    Measured: 16 months

  4. 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.

    Measured: 16 months

  5. 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.

    Measured: 16 months

  6. 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.

    Measured: 16 months

Secondary outcomes (4)

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

    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.

    Measured: 16 months

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

    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.

    Measured: 16 months

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

    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.

    Measured: 16 months

  4. Spanish Beck Anxiety Inventory (Beck & Steer, 1993)

    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.

    Measured: 16 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2018
  2. Study startDec 2021 (estimated)
  3. Primary completionAug 2022 (estimated)
  4. Study completionAug 2022 (estimated)

Why it stopped: We are no longer recruiting research participants for this study. Also, a co-investigator is no longer working at this institution and is no longer a part of this study.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03621397
Sponsor's protocol ID
1222300-1
Status last verified
Jan 2022
First submitted
31 Jul 2018
Last updated
18 Jan 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 7783470

  • 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.

  • 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.

    PubMed 29190120

  • 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.

    PubMed 9375194

  • 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.

  • 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.

    PubMed 1593914

  • 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.

    PubMed 11124729

Questions about this trial

What is this clinical trial studying?

A study testing brainHQ by Posit Science in people with Subarachnoid Hemorrhage and Cognitive Impairment, run by DHR Health Institute for Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Spanish Rey Auditory Verbal Learning Test (time frame: 16 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03621397, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2022.

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