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

Primary Purpose

Subarachnoid Hemorrhage, Cognitive Impairment, Quality of Life

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

brainHQ by Posit Science

About this trial

This is an interventional treatment trial for Subarachnoid Hemorrhage focused on measuring Spanish-speakers, Subarachnoid hemorrhage, Cognitive Intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

DHR Health Neuroscience Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cognitive Intervention Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

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.

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.

Secondary Outcome Measures

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.

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.

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.

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.

Full Information

NCT ID

NCT03621397

First Posted

July 31, 2018

Last Updated

January 3, 2022

Sponsor

DHR Health Institute for Research and Development

1. Study Identification

Unique Protocol Identification Number

NCT03621397

Brief Title

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

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Withdrawn

Why 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.

Study Start Date

December 2021 (Anticipated)

Primary Completion Date

August 2022 (Anticipated)

Study Completion Date

August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

DHR Health Institute for Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Spanish-speakers, Subarachnoid hemorrhage, Cognitive Intervention

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cognitive Intervention Group

Arm Type

Experimental

Arm Description

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

Intervention Type

Device

Intervention Name(s)

brainHQ by Posit Science

Intervention Description

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.

Primary Outcome Measure Information:

Title

Spanish Rey Auditory Verbal Learning Test

Description

Time Frame

16 months

Title

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

Description

Time Frame

16 months

Title

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

Description

Time Frame

16 months

Title

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

Description

Time Frame

16 months

Title

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

Description

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.

Time Frame

16 months

Title

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

Description

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

Time Frame

16 months

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

16 months

Title

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

Description

Time Frame

16 months

Title

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

Description

Time Frame

16 months

Title

Spanish Beck Anxiety Inventory (Beck & Steer, 1993)

Description

Time Frame

16 months

Other Pre-specified Outcome Measures:

Title

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

Description

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.

Time Frame

One week

Title

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

Description

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.

Time Frame

One week

Title

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

Description

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.

Time Frame

One week

Title

Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV; Wechsler, 2008) Vocabulary subtest

Description

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.

Time Frame

One week

Title

Wide Range Achievement Test-Fourth Edition (WRAT-4; Wilkson & Robertson, 2006) Reading subtest

Description

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.

Time Frame

One week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eduardo Estevis, Ph.D.

Organizational Affiliation

DHR Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

DHR Health Neuroscience Institute

City

Edinburg

State/Province

Texas

ZIP/Postal Code

78539

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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