Clinical trial NCT04644172: Improving Thinking in Everyday Life After Covid-19
Official title: Improving Thinking in Everyday Life: Pilot Study C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid-19
Cognitive Impairment
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2020-11-25
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Pilot RCT with two arms: Immediate and Delayed Treatment with crossover to experimental intervention after 6-month followup. Delayed group is allowed to receive usual care while awaiting crossover. Testing is done for both groups at pre- and post-treatment and 6-month followup.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* presence of cognitive impairment due to Covid-19 infection
* mild-to-moderate general cognitive impairment as determined by a Montreal Cognitive Assessment (MOCA) score between 10-25
* at least 3 months after positive status for Covid-19
* 18 years or older
* 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

Primary outcomes:
measure: Canadian Occupation Performance Measure (COPM)
timeFrame: Change from Day 0 to Day 17
Secondary outcomes:
measure: Improved and New Cognitive Ability (INCA)
timeFrame: Change from Day 0 to Day 17
measure: Cognitive Task Activity Log (CTAL) How Well Scale
timeFrame: Change from Day 0 to Day 17
measure: Cognitive Task Activity Log (CTAL) Independence Scale
timeFrame: Change from Day 0 to Day 17
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Edward Taub
role: PRINCIPAL_INVESTIGATOR
References: