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

Primary Purpose

Brain Injuries, Traumatic, Executive Dysfunction

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home-based telehealth GOALS
In-person GOALS
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Injuries, Traumatic focused on measuring Veterans, Rehabilitation, Cognitive training, Telehealth

Eligibility Criteria

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

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

Sites / Locations

  • San Francisco VA Medical Center, San Francisco, CARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Home-based telehealth GOALS

In-person GOALS

Arm Description

Participants in this arm will receive the GOALS intervention via in-home video telehealth.

Participants in this arm will receive the GOALS intervention in the traditional in-person format.

Outcomes

Primary Outcome Measures

Overall Attention and Executive Function Change
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.
Profile of Mood States (POMS) Total Mood Disturbance Change
Measure of emotion regulation and overall psychological distress. Scores range from 0-200, and higher scores indicate more distress.
Mayo-Portland Adaptability Inventory Total Score Change
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.

Secondary Outcome Measures

Full Information

First Posted
September 30, 2019
Last Updated
December 21, 2022
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT04111549
Brief Title
GOALS Cognitive Training Delivered to Aging Veterans in Person or Via Telehealth
Acronym
TeleGOALS
Official Title
Rehabilitation of Executive Function in Aging Veterans With History of TBI
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 9, 2020 (Actual)
Primary Completion Date
September 9, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will use technology to deliver effective treatment for cognitive problems associated with TBI to Veterans at home, which may result in improved daily functioning and increased access to health care for the growing population of aging Veterans with history of TBI. The successful completion of this project may also increase older Veterans' ability to participate in research through increased understanding of the effect of in-home research opportunities on recruitment and retention. Additionally, the evidence gathered from this study may be used in future research studying home-based cognitive rehabilitation treatments for Veterans using telehealth technology.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries, Traumatic, Executive Dysfunction
Keywords
Veterans, Rehabilitation, Cognitive training, Telehealth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
Outcomes assessors will be blinded to which condition (in-person or home-based telehealth) a participant completed.
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Home-based telehealth GOALS
Arm Type
Experimental
Arm Description
Participants in this arm will receive the GOALS intervention via in-home video telehealth.
Arm Title
In-person GOALS
Arm Type
Active Comparator
Arm Description
Participants in this arm will receive the GOALS intervention in the traditional in-person format.
Intervention Type
Other
Intervention Name(s)
Home-based telehealth GOALS
Intervention 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.
Intervention Type
Other
Intervention Name(s)
In-person GOALS
Intervention 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.
Primary Outcome Measure Information:
Title
Overall Attention and Executive Function Change
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.
Time Frame
Baseline, after 5 week delay repeat baseline, and after 5 week intervention
Title
Profile of Mood States (POMS) Total Mood Disturbance Change
Description
Measure of emotion regulation and overall psychological distress. Scores range from 0-200, and higher scores indicate more distress.
Time Frame
Baseline, after 5 week delay repeat baseline, and after 5 week intervention
Title
Mayo-Portland Adaptability Inventory Total Score Change
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.
Time Frame
Baseline, after 5 week delay repeat baseline, and after 5 week intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erica S Kornblith, PhD
Phone
(415) 221-4810
Ext
24125
Email
Erica.kornblith@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erica S. Kornblith, PhD
Organizational Affiliation
San Francisco VA Medical Center, San Francisco, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco VA Medical Center, San Francisco, CA
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erica S Kornblith, PhD
Phone
415-221-4810
Ext
24125
Email
Erica.kornblith@va.gov
First Name & Middle Initial & Last Name & Degree
Erica S. Kornblith, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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