Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04644172 |
| Other study ID # |
IRB-300002814C |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2021 |
| Est. completion date |
May 15, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
University of Alabama at Birmingham |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this initial study is to evaluate a new form of cognitive rehabilitation
therapy for improving your ability to think, particularly how rapidly you process information
that you receive from your senses, e.g., sight, hearing, and smell. The study will also test
how often and how well you carry out tasks that rely on thinking in your daily life. You will
be randomly assigned to receive the new therapy soon or about three months later. In other
words, your treatment schedule will be determined by chance. The new therapy involves
intensive, repetitive cognitive exercises (up to 3.5hr/day for 10 consecutive weekdays) with
rest periods interspersed as needed.
Description:
The purpose of this pilot study is to develop and test an intervention for slow processing of
sensory input that not only increases the speed of processing but also produces improvement
in how much and how well adults with this type of cognitive impairment carry out everyday
tasks that rely on cognitive function. The intervention will combine Speed of Processing
Training (SOPT) with a modified form of the Transfer Package (TP) from Constraint-Induced
Movement therapy (CI therapy). SOPT has been shown to increase speed of processing in a
variety of patient populations. The Transfer Package has been shown to produce transfer of
gains from the treatment setting to everyday life when combined with training of arm use in
the treatment in adults after stroke.
This early phase, randomized controlled trial (RCT) will have two arms: Immediate SOPT+TP
(experimental group) and Delayed SOPT+TP (control group). The Immediate SOPT+TP group will
receive the experimental intervention immediately after pre-treatment testing, and then be
followed for a year. The Delayed SOPT+TP group will receive testing on the same schedule as
the Immediate group up to 3-month follow-up. Delayed group participants will be permitted to
receive care that is available in the community as part of typical clinical care during this
period. After 3-month follow-up testing, Delayed group participants will receive the
experimental intervention and then be followed up for a year. Thus, the study design is a RCT
with a usual care control group featuring crossover to the experimental intervention for that
group at 3 month follow-up.
In the experimental intervention, the length of each treatment session will vary from 2 to
3.5 hours per day, the number of treatment days per week will range from 2 to 5, and the
number of weeks of treatment will range from 2 to 10. Accordingly, the interval between
testing occasions may change depending on the findings from initial pilot work. Total hours
of treatment will not exceed 35. Ranges are given rather than precise values because part of
the purpose of this pilot work is to decide, on a preliminary basis, what is the best
schedule of delivery. In addition, four follow-up telephone calls will be conducted each week
for the first month after the end of treatment. Then, a follow-up telephone call will be
placed once a month for up to 11 months. These telephone calls will permit elements of the
Transfer Package to be delivered remotely, helping the patient to transition from taking part
in treatment to living their daily lives. Each telephone call will last 30 to 60 minutes.
If a caregiver is available, the caregiver will be asked to complete interviews about the
participant's progress (see below) and will be invited to support the participant in
following the Transfer Package elements of the treatment (see below).
The outcomes that will be assessed are: speed of processing, performance of instrumental
activities of daily living (IADL) that place demands on cognitive activity in the laboratory
setting, and performance of IADL that place demands on cognitive activity outside the
laboratory setting.
The diagram immediately below shows the treatment and testing schedule for the Immediate
Treatment group.
Informed Consent Interview → Screening → Pre-treatment Testing → Treatment (2-10 weeks) →
Post-treatment testing → up to 4 weekly follow-up phone calls → up to 2 monthly follow-up
phone calls → 3-month follow-up testing → up to 9 monthly follow-up calls → 12-month
follow-up testing
The diagram immediately below show the treatment and testing schedule for the Delayed
Treatment group.
Informed Consent Interview → Screening → Baseline Testing 1 → Usual care (2-10 weeks) →
Baseline Testing 2 → 3 months → Pre-treatment Testing → Treatment (2-10 weeks) →
Post-treatment testing → up to 4 weekly follow-up phone calls → up to 2 monthly follow-up
phone calls → 3-month follow-up testing → up to 9 monthly follow-up calls → 12-month
follow-up testing
Repeated measures analysis of variance models with a between-subjects factor will be used to
evaluate if statistically significant improvements take place as a result of treatment. The
primary comparison will be between the Immediate Treatment and Delayed Treatment groups at
post-treatment. The cross-over design permits a another, secondary evaluation of the efficacy
of the experimental intervention by comparing the usual care to the SOPT+TP period in the
Delayed Treatment group.
