Ignite Creation Date:
2024-05-06 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 12:49 PM
Study NCT ID:
NCT03582670
Status:
COMPLETED
Last Update Posted:
2021-04-06
First Post:
2018-06-06
Brief Title:
Prospective Memory Training in Parkinson Disease
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Prospective Memory Training in Parkinson Disease
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 she 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 participants everyday retrospective and prospective memory
Comprehensive Assessment of Prospective Memory CAPM attached - Used to rate the participants everyday prospective memory
Impact of Participation and Autonomy IPA attached- A questionnaire about the participants 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
Participants 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 15 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 ie 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 she 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 hisher 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 she will be practicing both types of tasks in the training games and can support the participants 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 participants 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 andor 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 15 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 participants 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 informants 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 participants 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 informants preference
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 she 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 participants everyday retrospective and prospective memory
Comprehensive Assessment of Prospective Memory CAPM attached - Used to rate the participants everyday prospective memory
Impact of Participation and Autonomy IPA attached- A questionnaire about the participants 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
Participants 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 15 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 ie 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 she 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 hisher 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 she will be practicing both types of tasks in the training games and can support the participants 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 participants 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 andor 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 15 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 participants 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 informants 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 participants 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 informants preference
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None