Transferring Speed of Processing Gains to Everyday Cognitive Tasks After Stroke

The University of Alabama at Birmingham logo

The University of Alabama at Birmingham

Status

Enrolling

Conditions

Stroke
Cognitive Dysfunction

Treatments

Behavioral: Healthy Lifestyle In-lab Training
Behavioral: Speed of Processing Training
Behavioral: Follow-up Phone Calls
Behavioral: Cognitive Transfer Packagke
Behavioral: Healthy Lifestyle Transfer Package
Behavioral: Family Caregiver Coaching
Behavioral: Instrumental Activities of Daily Living In-lab Training

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05162781
IRB-300008211
1R01AG070049-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

120 participants in 4 patient groups

CICT with Follow-up Phone Calls
Experimental group
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.
Treatment:
Behavioral: Instrumental Activities of Daily Living In-lab Training
Behavioral: Family Caregiver Coaching
Behavioral: Cognitive Transfer Packagke
Behavioral: Follow-up Phone Calls
Behavioral: Speed of Processing Training
CICT without Follow-up Phone Calls
Experimental group
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.
Treatment:
Behavioral: Instrumental Activities of Daily Living In-lab Training
Behavioral: Family Caregiver Coaching
Behavioral: Cognitive Transfer Packagke
Behavioral: Speed of Processing Training
BF-HELP with Follow-up Phone Calls
Active Comparator group
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.
Treatment:
Behavioral: Family Caregiver Coaching
Behavioral: Healthy Lifestyle Transfer Package
Behavioral: Follow-up Phone Calls
Behavioral: Speed of Processing Training
Behavioral: Healthy Lifestyle In-lab Training
BF-HELP without Follow-up Phone Calls
Active Comparator group
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.
Treatment:
Behavioral: Family Caregiver Coaching
Behavioral: Healthy Lifestyle Transfer Package
Behavioral: Follow-up Phone Calls
Behavioral: Speed of Processing Training
Behavioral: Healthy Lifestyle In-lab Training

Trial contacts and locations

1

Loading...

Central trial contact

Staci McKay, BS; Helen Bliss, HSD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems