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Transferring Speed of Processing Gains to Everyday Cognitive Tasks After Stroke

Primary Purpose

Stroke, Cognitive Dysfunction

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Speed of Processing Training
Instrumental Activities of Daily Living In-lab Training
Cognitive Transfer Packagke
Family Caregiver Coaching
Follow-up Phone Calls
Healthy Lifestyle In-lab Training
Healthy Lifestyle Transfer Package
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, cognitive dysfunction, cognitive processing speed, IADL

Eligibility Criteria

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

Primary Inclusion Criteria:

  • stroke > 1 year previously
  • mild-to-moderate general cognitive impairment as determined by a Montreal Cognitive Assessment (MOCA) score between 10-26
  • some impairment in performance of daily activities; this will be determined by a score of 3 or below on the Cognitive Task Activity Log (CTAL)

Additional Inclusion Criteria:

  • 40 years or older; no upper limit if medically stable
  • sufficiently fit, from both a physical and mental health perspective, to take part in study
  • adequate sight and hearing to complete UFOV test
  • adequate thinking skills, e.g., ability to follow directions, retain information, to complete UFOV and CTAL, as marked by judgement of the screener that the candidate is able to adequately complete the UFOV and CTAL
  • reside in the community (as opposed to a hospital or skilled nursing facility)
  • able to travel to laboratory on multiple occasions
  • caregiver available

Exclusion Criteria:

  • cognitive impairment due to a developmental disability, psychiatric disorder, or substance abuse or due to another type of brain injury, such a traumatic brain injury, or a progressive brain disease, such as Alzheimer's Dementia

Sites / Locations

  • University of Alabama at BirminghamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

CICT with Follow-up Phone Calls

CICT without Follow-up Phone Calls

BF-HELP with Follow-up Phone Calls

BF-HELP without Follow-up Phone Calls

Arm Description

Participants in this group will receive 35 hours of training. Ten 1-hour sessions of SOPT will be scheduled in the home with training conducted independently by participants. Ten 2.5 hours of in-lab, face-to-face, therapist directed sessions will be scheduled. These sessions will feature a brief period of SOPT; the bulk of the sessions will be committed to (A) shaping on IADL and (B) the Cognitive Transfer Package. Training sessions will be permitted to be scheduled over 2-4 weeks. Family caregivers will receive training on how to best support participants in their therapeutic program. After treatment ends, four phone calls will be placed once-a-week for four weeks, then once-a-month for 11 months. The follow-up calls will target transition of any changes achieved during treatment into everyday life on a long-term basis.

Participants in this group will receive 35 hours of training. Ten 1-hour sessions of SOPT will be scheduled in the home with training conducted independently by participants. Ten 2.5 hours of in-lab, face-to-face, therapist directed sessions will be scheduled. These sessions will feature a brief period of SOPT; the bulk of the sessions will be committed to (A) shaping on IADL and (B) the Cognitive Transfer Package. Training sessions will be permitted to be scheduled over 2-4 weeks. Family caregivers will receive training on how to best support participants in their therapeutic program. No follow-up phone calls will be made after treatment ends.

Participants in this group will receive 35 hours of training. Ten 1-hour sessions of SOPT will be scheduled in the home with training conducted independently by participants. Ten 2.5 hours of in-lab, face-to-face, therapist directed sessions will be scheduled. These sessions will feature a brief period of SOPT; the bulk of the sessions will be committed to (A) training on relaxation, healthy nutrition, and healthy sleep, and (B) the Healthy Lifestyle Transfer Package. Training sessions will be permitted to be scheduled over 2-4 weeks. Family caregivers will receive training on how to best support participants in their therapeutic program. After treatment ends, four phone calls will be placed once-a-week for four weeks, then once-a-month for 11 months. The follow-up calls will target transition of any changes achieved during treatment into everyday life on a long-term basis.

Participants in this group will receive 35 hours of training. Ten 1-hour sessions of SOPT will be scheduled in the home with training conducted independently by participants. Ten 2.5 hours of in-lab, face-to-face, therapist directed sessions will be scheduled. These sessions will feature a brief period of SOPT; the bulk of the sessions will be committed to (A) training on relaxation, healthy nutrition, and healthy sleep, and (B) the Healthy Lifestyle Transfer Package. Training sessions will be permitted to be scheduled over 2-4 weeks. Family caregivers will receive training on how to best support participants in their therapeutic program. No follow-up phone calls will be made after treatment ends.

Outcomes

Primary Outcome Measures

Quality of Life in Neurological Disorders Measures (Neuro-QOL), Cognitive Function Scale
The Neuro-QOL assesses function in daily life in several domains; it is a widely used, validated, transdiagnostic, self-report measure. The development and use of the Neuro-QOL is supported by the National Institutes of Health. The component of the Neuro-QOL that assessed cognitive function will be used here. Items are rated by respondents using a five-point scale: 1 = not at all, 5 = very much. Higher scores indicate better function.

Secondary Outcome Measures

Full Information

First Posted
November 19, 2021
Last Updated
August 11, 2023
Sponsor
University of Alabama at Birmingham
Collaborators
National Institute on Aging (NIA), Posit Science
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1. Study Identification

Unique Protocol Identification Number
NCT05162781
Brief Title
Transferring Speed of Processing Gains to Everyday Cognitive Tasks After Stroke
Official Title
Transferring Speed of Processing Gains to Everyday Cognitive Tasks After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 9, 2022 (Actual)
Primary Completion Date
July 30, 2025 (Anticipated)
Study Completion Date
July 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
National Institute on Aging (NIA), Posit Science

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will compare two approaches to cognitive rehabilitation in adults with stroke with persistent, mild to moderate, cognitive impairment. Both approaches will feature a web-based computer "game" that trains cognitive processing speed, i.e., how quickly individuals process information that they receive through their senses. This training is termed Speed of Processing Training (SOPT). One approach will add (A) in-lab training on everyday activities with important cognitive components and (B) procedures designed to transfer improvements in cognition from the treatment setting to everyday life. This approach is termed Constraint-Induced Cognitive Therapy (CICT). The other approach will add (A) in-lab training on relaxation, healthy nutrition, and healthy sleep and (B) procedures designed to promote integration of these lifestyle changes into everyday life. This approach is termed Brain Fitness-Heath Education Lifestyle Program (BF-HELP). Both CICT and BF-HELP will involve 35 hours of training. Ten 1-hour sessions of SOPT will be scheduled in the home with training conducted independently by participants. Ten 2.5 hours of in-lab, face-to-face, therapist directed sessions will be scheduled. These sessions will feature a brief period of SOPT; the bulk of the sessions will be committed to in-lab training on the target behaviors and the procedures designed to promote transfer of therapeutic gains to daily life; The set of the latter procedures is termed the Transfer Package. To accommodate the demands of participants' other activities, training sessions will be permitted to be scheduled as tightly as every weekday over 2 weeks or as loosely as every other weekday or so over 4 weeks. Family caregivers in both groups will also receive training on how to best support participants in their therapeutic program. The study will also test if there is an advantage to placing follow-up phone calls after treatment ends. The purpose of the calls will be to support transition of any behavioral changes achieved during treatment into everyday life on a long-term basis. Participants will be randomly assigned to the interventions. Testing will happen one month before treatment, one day before treatment, one day afterwards, and 6- and 12-months afterwards. Outcomes measured will include cognitive processing speed, cognitive function on laboratory tests, and spontaneous performance of everyday activities with important cognitive components in daily life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cognitive Dysfunction
Keywords
stroke, cognitive dysfunction, cognitive processing speed, IADL

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Half of the participants will receive CICT, which consists of SOPT, IADL training in the lab, and a Transfer Package targeting IADL performance outside it. The other half will receive BF-HELP, which consists of SOPT, in-lab training on relaxation, nutrition, and sleep hygiene, and a Transfer Package targeting implementation of these lifestyle changes outside it. Half of the CICT group will receive 15 follow-up phone calls over the course of one year. The other CICT participants will receive none. The same will apply to the BF-HELP group. The phone calls will support integration of the behavioral changes targeted during treatment to everyday life afterwards. For all participants, outcome testing will take place one month before treatment (Baseline 1), one day before treatment (Baseline 2 aka Pre-treatment), one day afterwards (Post-treatment), 6-months afterwards (6-month Follow-up), and 12-months afterwards (12-month follow-up). Randomization will take place after Baseline 2.
Masking
Outcomes Assessor
Masking Description
Tester will be blinded to group assignment of participants.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CICT with Follow-up Phone Calls
Arm Type
Experimental
Arm Description
Participants in this group will receive 35 hours of training. Ten 1-hour sessions of SOPT will be scheduled in the home with training conducted independently by participants. Ten 2.5 hours of in-lab, face-to-face, therapist directed sessions will be scheduled. These sessions will feature a brief period of SOPT; the bulk of the sessions will be committed to (A) shaping on IADL and (B) the Cognitive Transfer Package. Training sessions will be permitted to be scheduled over 2-4 weeks. Family caregivers will receive training on how to best support participants in their therapeutic program. After treatment ends, four phone calls will be placed once-a-week for four weeks, then once-a-month for 11 months. The follow-up calls will target transition of any changes achieved during treatment into everyday life on a long-term basis.
Arm Title
CICT without Follow-up Phone Calls
Arm Type
Experimental
Arm Description
Participants in this group will receive 35 hours of training. Ten 1-hour sessions of SOPT will be scheduled in the home with training conducted independently by participants. Ten 2.5 hours of in-lab, face-to-face, therapist directed sessions will be scheduled. These sessions will feature a brief period of SOPT; the bulk of the sessions will be committed to (A) shaping on IADL and (B) the Cognitive Transfer Package. Training sessions will be permitted to be scheduled over 2-4 weeks. Family caregivers will receive training on how to best support participants in their therapeutic program. No follow-up phone calls will be made after treatment ends.
Arm Title
BF-HELP with Follow-up Phone Calls
Arm Type
Active Comparator
Arm Description
Participants in this group will receive 35 hours of training. Ten 1-hour sessions of SOPT will be scheduled in the home with training conducted independently by participants. Ten 2.5 hours of in-lab, face-to-face, therapist directed sessions will be scheduled. These sessions will feature a brief period of SOPT; the bulk of the sessions will be committed to (A) training on relaxation, healthy nutrition, and healthy sleep, and (B) the Healthy Lifestyle Transfer Package. Training sessions will be permitted to be scheduled over 2-4 weeks. Family caregivers will receive training on how to best support participants in their therapeutic program. After treatment ends, four phone calls will be placed once-a-week for four weeks, then once-a-month for 11 months. The follow-up calls will target transition of any changes achieved during treatment into everyday life on a long-term basis.
Arm Title
BF-HELP without Follow-up Phone Calls
Arm Type
Active Comparator
Arm Description
Participants in this group will receive 35 hours of training. Ten 1-hour sessions of SOPT will be scheduled in the home with training conducted independently by participants. Ten 2.5 hours of in-lab, face-to-face, therapist directed sessions will be scheduled. These sessions will feature a brief period of SOPT; the bulk of the sessions will be committed to (A) training on relaxation, healthy nutrition, and healthy sleep, and (B) the Healthy Lifestyle Transfer Package. Training sessions will be permitted to be scheduled over 2-4 weeks. Family caregivers will receive training on how to best support participants in their therapeutic program. No follow-up phone calls will be made after treatment ends.
Intervention Type
Behavioral
Intervention Name(s)
Speed of Processing Training
Other Intervention Name(s)
SOPT
Intervention Description
This training component targets cognitive processing speed, i.e., how quickly individuals process information that they receive through their senses. Cognitive processing speed is thought to be a basic capacity of the brain that underlies several other cognitive functions. Training is implemented using a web-based computer "game", in which participants are required to fixate on a target at the center of the screen and identify targets in the periphery. The game is made progressively more difficult, in small increments, as participants gain mastery by increasing the speed at which targets are presented and increasing the number of distractors.
Intervention Type
Behavioral
Intervention Name(s)
Instrumental Activities of Daily Living In-lab Training
Other Intervention Name(s)
IADL In-lab Training
Intervention Description
The training component is thought to bridge SOPT training, which targets a basic cognitive capacity, and IADL performance in daily life. This training component will involve repeated trials in which participants will practice carrying out simulated IADL tasks in the lab under the supervision of the trainer. The training will follow shaping principles, i.e., task requirements will be made progressively more challenging, in small increments, as participants gain mastery. Frequent, positive feedback will be provided.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Transfer Packagke
Intervention Description
This training component is designed to transfer improvements in cognition from the treatment setting to everyday life. Elements of this package include negotiating a behavioral contract about the roles of the participant and family caregiver in the treatment, monitoring behavior outside the lab, and assigning performance of IADL as homework.
Intervention Type
Behavioral
Intervention Name(s)
Family Caregiver Coaching
Intervention Description
One or more family members of the participant will receive coaching on how to best support the participant in carrying out the in-home components of the intervention.
Intervention Type
Behavioral
Intervention Name(s)
Follow-up Phone Calls
Intervention Description
After treatment ends, four phone calls will be placed once-a-week for four weeks, then once-a-month for 11 months. The follow-up calls will target transition of any changes achieved during treatment into everyday life on a long-term basis after.
Intervention Type
Behavioral
Intervention Name(s)
Healthy Lifestyle In-lab Training
Intervention Description
This training component is designed to promote lifestyle changes that support brain fitness. Participants will receive education and coaching in the lab on relaxation, healthy nutrition, and healthy sleep.
Intervention Type
Behavioral
Intervention Name(s)
Healthy Lifestyle Transfer Package
Intervention Description
This training component is designed to support integration into everyday life of the lifestyle changes training in the lab. Elements of this package include negotiating a behavioral contract about the roles of the participant and family caregiver in the treatment, monitoring behavior outside the lab, and assigning relaxation exercises, for example, as homework.
Primary Outcome Measure Information:
Title
Quality of Life in Neurological Disorders Measures (Neuro-QOL), Cognitive Function Scale
Description
The Neuro-QOL assesses function in daily life in several domains; it is a widely used, validated, transdiagnostic, self-report measure. The development and use of the Neuro-QOL is supported by the National Institutes of Health. The component of the Neuro-QOL that assessed cognitive function will be used here. Items are rated by respondents using a five-point scale: 1 = not at all, 5 = very much. Higher scores indicate better function.
Time Frame
Change from Day 30 to Day 60, i.e., from Pre- to Post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Primary Inclusion Criteria: stroke > 1 year previously mild-to-moderate general cognitive impairment as determined by a Montreal Cognitive Assessment (MOCA) score between 10-26 some impairment in performance of daily activities; this will be determined by a score of 3 or below on the Cognitive Task Activity Log (CTAL) Additional Inclusion Criteria: 40 years or older; no upper limit if medically stable sufficiently fit, from both a physical and mental health perspective, to take part in study adequate sight and hearing to complete UFOV test adequate thinking skills, e.g., ability to follow directions, retain information, to complete UFOV and CTAL, as marked by judgement of the screener that the candidate is able to adequately complete the UFOV and CTAL reside in the community (as opposed to a hospital or skilled nursing facility) able to travel to laboratory on multiple occasions caregiver available Exclusion Criteria: cognitive impairment due to a developmental disability, psychiatric disorder, or substance abuse or due to another type of brain injury, such a traumatic brain injury, or a progressive brain disease, such as Alzheimer's Dementia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Edward Taub, PhD
Phone
205-934-2471
Email
etaub@uab.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Gitendra Uswatte, PhD
Phone
205-975-5089
Email
guswatte@uab.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward Taub, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Staci McKay, BS
Phone
205-934-9768
Email
stacemc@uab.edu
First Name & Middle Initial & Last Name & Degree
Edward Taub, PhD
Phone
205-934-2471
Email
etaub@uab.edu

12. IPD Sharing Statement

Learn more about this trial

Transferring Speed of Processing Gains to Everyday Cognitive Tasks After Stroke

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