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GOALS Cognitive Training Delivered to Aging Veterans in Person or Via Telehealth

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Studies

Study First Submitted Date 2019-09-30
Study First Posted Date 2019-10-01
Last Update Posted Date 2022-12-22
Start Month Year September 9, 2020
Primary Completion Month Year September 9, 2024
Verification Month Year December 2022
Verification Date 2022-12-31
Last Update Posted Date 2022-12-22

Detailed Descriptions

Sequence: 20651181
Description The goal of this project is to investigate the feasibility and acceptability of using technology to implement home-based executive function training for aging Veterans with history of traumatic brain injury (TBI).

Background: Problems with attention and executive control are some of the most common sequelae of TBI, and these areas of cognition are also known to be vulnerable to aging. Goal Oriented Attentional Self-Regulation (GOALS) is a manualized cognitive training intervention for problems with attention and executive control that has been shown to improve cognitive, emotional, and functional outcomes in civilians and Veterans with history of TBI, including Veterans 65 and older, and healthy older adults.

Relevance and significance to Veteran’s health: TBI is prevalent among Veterans. Home-based telehealth (HBT) may be an effective tool to address lack of access to health care for aging Veterans.

Aim 1: Complete adaptation of the IP-GOALS protocol for a) HBT use and b) use with older Veterans via collection of feedback from [n=8] Veterans 65+ with history of TBI and cognitive complaints. Aim 2: Examine the feasibility (defined as recruitment yield, dropout after randomization, retention, and adherence) and participant-rated acceptability of [IP and] HBT-GOALS in n=36 Veterans 65+ with history of TBI and cognitive complaints. Hypothesis 2: Feasibility will be demonstrated by achieving targeted recruitment goals with reasonable rates of dropout after randomization, retention, and adherence, and high levels of participant-rated acceptability in both groups. Aim 3: Estimate effect sizes for [HBT-GOALS and IP-GOALS using a double-baseline control] on improving a) cognitive performance and self-reported b) emotional regulation and c) daily functioning in the same Aim 2 study cohort to inform sample size requirements for a future clinical trial. Hypothesis 3: Effect size estimates will provide evidence of clinically meaningful improvement on a) cognitive functioning (Attention and Executive Function Composite), b) emotional regulation (Profile of Mood States Total Mood Disturbance Score), and c) daily functioning outcomes (Mayo-Portland Adaptability Inventory Total Score). Exploratory analysis a) will examine whether Veteran characteristics (e.g., age, sex, family/caregiver support, distance to nearest clinic, and health/mobility issues including chronic pain) are associated with differences in participant-rated acceptability and feasibility (i.e., recruitment yield, dropout after randomization, retention and adherence), and [response to IP/HBT-GOALS vs. double baseline control.] Exploratory analysis b) will examine distribution of responses to select criteria to define responders in future studies.

Methods: Adaptation phase (Aim 1): Adaptation of the existing GOALS protocol for a) HBT use and b) use with older Veterans will be completed by collecting post-training feasibility and acceptability data. Pilot phase (Aims 2 and 3 and Exploratory Analyses): Feasibility, acceptability, cognitive, emotional, and daily functioning data will be collected from n=36 Veterans 65 or older before (baseline and delay baseline) and after participation in GOALS training delivered in person (IP) or via HBT. Veterans will be randomly assigned to IP or HBT. Outcome measures include participant-rated acceptability; feasibility (i.e., recruitment yield, dropout after randomization, retention, and adherence); standardized and validated measures of neurocognitive functioning; self-report of symptoms of depression, PTSD, mood disturbance, and daily functioning.

Innovation: The proposed study is the first to investigate implementation of an established cognitive rehabilitation intervention for use with aging Veterans with history of TBI and delivery via in-home videoconferencing technology.

Implications: This research may promote improved daily functioning for aging Veterans with history of TBI through rehabilitation of executive function, and increase access to such treatment.

Facilities

Sequence: 199335576
Status Recruiting
Name San Francisco VA Medical Center, San Francisco, CA
City San Francisco
State California
Zip 94121
Country United States

Facility Contacts

Sequence: 28019596
Facility Id 199335576
Contact Type primary
Name Erica S Kornblith, PhD
Email [email protected]
Phone 415-221-4810
Phone Extension 24125

Facility Investigators

Sequence: 18277635
Facility Id 199335576
Role Principal Investigator
Name Erica S. Kornblith, PhD

Conditions

Sequence: 51988662 Sequence: 51988663
Name Brain Injuries, Traumatic Name Executive Dysfunction
Downcase Name brain injuries, traumatic Downcase Name executive dysfunction

Id Information

Sequence: 40016410 Sequence: 40016411
Id Source org_study_id Id Source secondary_id
Id Value E3073-W Id Value 1IK2RX003073-01A2
Id Type U.S. NIH Grant/Contract
Id Link https://reporter.nih.gov/quickSearch/1IK2RX003073-01A2

Countries

Sequence: 42411166
Name United States
Removed False

Design Groups

Sequence: 55391608 Sequence: 55391609
Group Type Experimental Group Type Active Comparator
Title Home-based telehealth GOALS Title In-person GOALS
Description Participants in this arm will receive the GOALS intervention via in-home video telehealth. Description Participants in this arm will receive the GOALS intervention in the traditional in-person format.

Interventions

Sequence: 52300318 Sequence: 52300319
Intervention Type Other Intervention Type Other
Name Home-based telehealth GOALS Name In-person GOALS
Description Goal Oriented Attentional Self-Regulation (GOALS) is a manualized cognitive training intervention for problems with attention and executive control that has been shown to improve cognitive, emotional, and functional outcomes in civilians and Veterans with history of TBI, including Veterans 65 and older, and healthy older adults. It will be delivered to aging Veterans with history of TBI via in-home video telehealth. Description Goal Oriented Attentional Self-Regulation (GOALS) is a manualized cognitive training intervention for problems with attention and executive control that has been shown to improve cognitive, emotional, and functional outcomes in civilians and Veterans with history of TBI, including Veterans 65 and older, and healthy older adults. It will be delivered to aging Veterans with history of TBI in person.

Keywords

Sequence: 79579858 Sequence: 79579859 Sequence: 79579860 Sequence: 79579861
Name Veterans Name Rehabilitation Name Cognitive training Name Telehealth
Downcase Name veterans Downcase Name rehabilitation Downcase Name cognitive training Downcase Name telehealth

Design Outcomes

Sequence: 176736258 Sequence: 176736259 Sequence: 176736260
Outcome Type primary Outcome Type primary Outcome Type primary
Measure Overall Attention and Executive Function Change Measure Profile of Mood States (POMS) Total Mood Disturbance Change Measure Mayo-Portland Adaptability Inventory Total Score Change
Time Frame Baseline, after 5 week delay repeat baseline, and after 5 week intervention Time Frame Baseline, after 5 week delay repeat baseline, and after 5 week intervention Time Frame Baseline, after 5 week delay repeat baseline, and after 5 week intervention
Description Composite of neuropsychological measures of attention and executive function: Letter Number Sequencing; Auditory Consonant Trigrams 9, 18, 36 sec; Digit Vigilance Test -Time & Errors; Trails B; DKEFS Stroop Inhibition Time & Errors; DKEFS Stroop Inhibition-Switching Time & Errors; DKEFS Verbal Fluency Switching; & DKEFS Design Fluency Switching. All scores will be transformed to z scores using published normative data and then an average will be calculated to obtain the single Overall Attention and Executive Function score. The composite z score will range from -3 to 3, with higher scores indicating better performance. Description Measure of emotion regulation and overall psychological distress. Scores range from 0-200, and higher scores indicate more distress. Description Post-TBI daily functioning: abilities and participation in daily activities. Scores range from 0-111, with lower scores indicating better function and greater ability and participation.

Browse Conditions

Sequence: 192764763 Sequence: 192764764 Sequence: 192764765 Sequence: 192764766 Sequence: 192764767 Sequence: 192764768 Sequence: 192764769 Sequence: 192764770
Mesh Term Brain Injuries Mesh Term Brain Injuries, Traumatic Mesh Term Brain Diseases Mesh Term Central Nervous System Diseases Mesh Term Nervous System Diseases Mesh Term Craniocerebral Trauma Mesh Term Trauma, Nervous System Mesh Term Wounds and Injuries
Downcase Mesh Term brain injuries Downcase Mesh Term brain injuries, traumatic Downcase Mesh Term brain diseases Downcase Mesh Term central nervous system diseases Downcase Mesh Term nervous system diseases Downcase Mesh Term craniocerebral trauma Downcase Mesh Term trauma, nervous system Downcase Mesh Term wounds and injuries
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48148214
Agency Class FED
Lead Or Collaborator lead
Name VA Office of Research and Development

Overall Officials

Sequence: 29180366
Role Principal Investigator
Name Erica S. Kornblith, PhD
Affiliation San Francisco VA Medical Center, San Francisco, CA

Central Contacts

Sequence: 11967885
Contact Type primary
Name Erica S Kornblith, PhD
Phone (415) 221-4810
Email [email protected]
Phone Extension 24125
Role Contact

Design Group Interventions

Sequence: 67904017 Sequence: 67904018
Design Group Id 55391608 Design Group Id 55391609
Intervention Id 52300318 Intervention Id 52300319

Eligibilities

Sequence: 30658092
Gender All
Minimum Age 65 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria:

Veterans aged 65 or older with history of chronic TBI (>6 months post-injury) — sustained either during military service

including in combat
or as a civilian
Self-reported cognitive complaints [1 moderate or severe cognitive symptom(s) on the Neurobehavioral Symptom Inventory (NSI [58]) that interfere(s) with daily function]

Endorsement of comfort and familiarity with technology and/or the possession of a personal computer, or other HBT-compatible device

i.e., tablet, or smartphone

Per the investigators’ preliminary patient survey, approximately 75% of the target population has access to a personal computer

Participants who do not endorse comfort/familiarity with technology may be eligible to participate if they can identify a family member or other caregiver who is consistently present and willing to assist with connecting to study sessions
A limited number of VA-issued tablets will be available for use by participants who do not have access to a personal computer or other HBT-compatible device

Exclusion Criteria:

Moderate-severe objective cognitive impairment, as measured by score <20 on the Montreal Cognitive Assessment (MoCA [59-61]), that interferes with daily functioning (i.e., Major Neurocognitive Disorder)

Unstable medical, neurologic, or psychiatric conditions precluding participation in research activities
Other reasons for being unable or unwilling to participate in study procedures
Ongoing illicit or prescription drug (Mini International Neuropsychiatric Interview Version 7.0.2 (MINI) [79] or alcohol abuse (Alcohol Use Disorders Test-Consumption (AUDIT-C) [62]>8)
Active psychosis
Poor English comprehension

Adult False
Child False
Older Adult True

Calculated Values

Sequence: 254268325
Number Of Facilities 1
Registered In Calendar Year 2019
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 65
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 3

Designs

Sequence: 30404921
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Single
Masking Description Outcomes assessors will be blinded to which condition (in-person or home-based telehealth) a participant completed.
Intervention Model Description After a 5-week delay repeat baseline, participants will be randomized to receive either in-person GOALS or GOALS delivered via home-based video telehealth.
Outcomes Assessor Masked True

Responsible Parties

Sequence: 28771445
Responsible Party Type Sponsor