Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03582670 |
| Other study ID # |
201709182 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2017 |
| Est. completion date |
July 1, 2020 |
Study information
| Verified date |
April 2021 |
| Source |
Washington University School of Medicine |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The long term goal of this work is to reduce disability among people with Parkinson disease
(PD) by enabling them to cope with cognitive decline so they can perform and participate in
desired activities and roles. This project focuses on prospective memory, or the ability to
remember to execute delayed intentions at the appropriate moment in the future. The current
study tests the effects of two primary cognitive intervention approaches (process training &
strategy training) on prospective memory performance in PD. The investigators will conduct a
single-blind randomized controlled trial in which individuals with mild cognitive impairment
in PD (PD-MCI; N = 90) will complete pre-training assessment, randomization to training group
(control, process training, strategy training), four training sessions (process and strategy
training groups), and post-training assessment.
Description:
RANDOMIZATION
Once a participant is enrolled in the study and completes the Pre-testing session (described
in detail below), they will be randomized into one of the following study groups:
1. Process Training Group - the trainer teaches the participant about event- and time-based
prospective memory tasks, respectively. The trainer simply tells the participant that
s/he will be practicing both types of tasks in training games.
2. Strategy Training Group - In training sessions 1 and 2, in addition to teaching about
event- and time-based tasks, the trainer teaches the participant specific strategies for
each type of task (implementation intentions for event-based and strategic
clock-checking for time-based; and instructs in their use before and during the training
games.
3. Contro1 Group - Receives no training sessions. Only Completes the PRE, POST and 1-month
& 3-month Follow Up portions of the study.
STUDY VISITS
- On the day of their testing appointment, participants will arrive at their designated
location at the WUSM Movement Disorders Clinic for their testing session. All
participants will provide written informed consent before their first testing session
begins, and the examiner will answer any questions before beginning testing. Scheduled
participants will be mailed or emailed (depending on their preference) study information
and a copy of the consent form. Participants will receive reminder calls 1-2 days before
their appointments.
- Demographics will be collected on all participants. This includes age, gender, years of
education, living status, race, and ethnicity after consent is obtained. This can be
completed online via Redcap or on paper at the testing session.
- Investigators will collect PD clinical characteristics from the Movement Disorders
Clinical Record. Clinical Characteristics includes: Hoehhn & Yahr Stage, year of first
PD symptoms, year of initial PD diagnosis, MoCA score at most recent clinic visit, Side
of symptom onset, type of symptom onset (tremor vs. bradykinesia), PD medications, and
most recent Unified Parkinson Disease Rating Scale Motor Score.
Participant Questionnaires:
Participants will complete the PRMQ, CAPM, IPA and BDI questionnaires.
- Prospective and Retrospective Memory Questionnaire (PRMQ; attached) - Used to rate the
participant's everyday retrospective and prospective memory.
- Comprehensive Assessment of Prospective Memory (CAPM; attached) - Used to rate the
participant's everyday prospective memory
- Impact of Participation and Autonomy (IPA; attached)- A questionnaire about the
participant's ability to take part in daily activities.
- Beck Depression Inventory (BDI, attached) - Used to characterize current depression,
which is common in PD.
Informant Report Questionnaires:
Participant's will identify an informant (spouse, relative, or close friend) to fill out the
PRMQ Proxy Report, a Self-Reported CAPM, and a CAPM - Proxy Report.
Demographics will be collected on all informants. This includes age, gender, years of
education, living status, race, and ethnicity.
Participant and Informant questionnaires can be filled out prior to the study session via
Redcap. Most participants request this method because it saves them time on the day of the
study session. The online questionnaires have a consent form to look over before filling them
out (see attached online consent), and the participant agrees to the consent by clicking
"Next" in the online form, and completing the questionnaires; if participants elect to
complete the questionnaires on paper, they can complete them at their testing session. The
research team will will first go over the written consent with them at the session before the
participant fills out the written questionnaires. Experimenters will check the questionnaires
for completion. This procedure will also be followed if the participant elects to fill out
the online questionnaire in Redcap.
Testing sessions:
Participants will perform testing while on their regular PD medications.
Pre-training Assessment: (1.5 hours) - MoCA and Virtual Week.
- The Montreal Cognitive Assessment (MoCA; attached) will be administered to assess global
cognition at the time of the study visit.
- The Virtual Week test (attached) will be administered to the participant. It is a
computerized board game that simulates daily life and real-world prospective memory
challenges. Each circuit represents one day in which the participant completes
time-appropriate activities and makes choices about them (i.e. the ongoing activity).
Each day has 8 prospective memory tasks (4 event based, 4 time based). Participants
complete a practice day and then three test days, with equivalent versions
counterbalanced across Pre and Post testing. The main outcome variable is the proportion
of correct prospective memory responses for each task type (12 event based, 12 time
based).
Strategy Training Sessions (GROUPS 1-Process Training AND 2-Strategy Training ONLY): These
are 4 sessions that occur over the next 2 weeks after the Pre-training Assessment. (1 HOUR
EACH) GROUP 1, Process training: In sessions 1 and 2, the trainer teaches the participant
about event- and time-based prospective memory tasks, respectively. In sessions 3 and 4, the
trainer simply tells the participant that s/he will be practicing both types of tasks in the
training games. In all sessions, the participant completes the training games with no
strategy instruction from the trainer. Feedback on accuracy is provided after each training
game. This is typical of a process training approach and expects that either practice of the
training tasks will improve prospective memory ability per se or participants will develop
effective strategies for completing prospective memory tasks on their own. At the end of each
session after completing both training games, the trainer reminds the participant of his/her
real-life prospective memory goals, provides a handout that lists the goals, and instructs
the participant to try to complete them as intended. It should be noted that the inclusion of
even this minimal level of discussion of real-life cognitive tasks is not typical of process
training interventions.
GROUP 2, Strategy Training: In training sessions 1 and 2, in addition to teaching about
event- and time-based tasks, the trainer teaches the participant specific strategies for each
type of task (implementation intentions for event-based and strategic clock-checking for
time-based) and instructs in their use before and during the training games. In sessions 3
and 4, the trainer tells the participant s/he will be practicing both types of tasks in the
training games and can support the participant's strategy use if needed. Feedback on accuracy
and strategy use are provided after each training game. At the end of each session after
completing the training games, the trainer and participant discuss how the strategies can be
applied to the participant's real-life prospective memory goals, and the trainer helps the
participant develop written action plans to do so. Plans are reviewed (and modified if
necessary) at each session.
- The Bangor Goal-Setting Interview (BGSI) - The BGSI is a structured assessment developed
for use in cognitive rehabilitation research. It offers a standardized means of
eliciting individual goals and rating goal attainment over time and has been
successfully used in RCTs with older adults, including those with mild to moderate
dementia. During the first two training sessions, after an explanation of the
prospective memory task types (session 1: event, session 2: time), participants complete
the BGSI with the trainer to identify and set goals for their real-life prospective
memory tasks. Participants identify up to 6 prospective memory tasks they anticipate
having to complete over the next 2 weeks (before Post assessment), define goals for
completing each task, and describe what needs to happen for the goal to be considered
partially (25%, 50%, and/or 75%) and fully achieved.
- Credibility/ Expectancy Questionnaire (CEQ; attached) - this will be completed by the
participant after the second training session to rate how credible they think the
strategy instruction training is, and how well they think it will work on 1) their
performance on the computer task, and 2) their performance in everyday life.
Post-training Assessment (1.5 hours) - (For Groups 1 (Process) and 2 (Strategy) = One week
after the last training session; For Group 3 (Control) = 3-4 weeks after the Pre-Training
Assessment): Virtual Week and NIH Toolbox Cognitive Battery
- The Virtual Week Task will be administered again, but with new tasks to remember.
- The NIH Toolbox Cognitive Battery (instructions attached) will be administered to obtain
an overall measure of executive function. This battery includes a Picture Vocabulary
Test, Picture Sequence Memory Test, Flanker Inhibitory Control and Attention Test,
Dimensional Change Card Sort Test, List Sorting Working Memory Test, Pattern Comparison,
and Oral Reading Test.
- GROUPS 1 (Process) and 2 (STRATEGY) ONLY: Based on their BGSI interview during the
training sessions, participants report on their performance of each task and, in
collaboration with the trainer, rate each task for attainment on a 10-point scale using
the previously determined descriptors as reference (higher scores indicate better goal
attainment). Task attainment scores are averaged to yield a mean attainment score.
One-month Follow-up Assessment (40 minutes) (One month after the Post Training Assessment):
The PRMQ, IPA and CAPM Questionnaires will be given to participants for a second time as
follow-up online in Redcap or by mail (depending on the participant's preference).
The study informant will fill out proxy-reported PRMQ and CAPM for a second time as a
follow-up online in Redcap or by mail (depending on the informant's preference).
Three-month Follow-up Assessment (40 minutes) (Three months after the Post Assessment):
The PRMQ, CAPM, and IPA Questionnaire will be given to participants for a third time as
follow-up online in Redcap or by mail (depending on the participant's preference).
The study informant will fill out proxy-reported PRMQ and CAPM for a third time as a
follow-up online in Redcap or by mail (depending on the informant's preference).
