Improving Prospective Memory Via Telehealth: A Randomized Feasibility Trial
Phase: NA
Conditions: Multiple Sclerosis
Sponsor: Trinity Health Of New England

Oﬃcial Title: Improving Prospective Memory Via Telehealth 
 
NCT Number: NCT05129293 
 
Document Date: 1/03/2022 
 
 
 

Table of Contents: 
 
Study Schema 
1.0 
Background 
2.0 
Rationale and Specific Aims 
3.0 
Inclusion/Exclusion Criteria 
4.0 
Enrollment/Randomization 
5.0 
Study Procedures 
6.0 
Reporting of Adverse Events or Unanticipated Problems involving Risk to 
Participants or Others 
7.0 
Study Withdrawal/Discontinuation 
8.0 
Statistical Considerations 
9.0 
Privacy/Confidentiality Issues 
10.0 Follow-up and Record Retention 
 
 

1.0 
Background 
 
Up to 70% of persons with multiple sclerosis (PwMS) have cognitive impairment1. These 
difficulties can present early in the disease2 and can negatively influence their everyday 
functioning3. One cognitive domain that is understudied in MS but can have significant 
functioning implications is prospective memory (PM) or “remembering to remember.” Two 
broad components are involved in PM: prospectively remembering that a task needs to be done 
and the retrospectively remembering the content of the task4. PM tasks can be categorized as 
being either event-based (e.g., “When the coffee machine chimes that the coffee is ready, I 
need to take my medication) or time-based (e.g., “At 1 pm, I have to go to my doctor’s 
appointment). PM tasks can occur once (e.g., going to get a one-time lab draw) or on a regular 
basis (e.g., taking a daily disease modifying therapy (DMT)). Other cognitive domains affected 
in MS can influence PM abilities. For instance, deficits in new learning, which is common in MS, 
can have a negative impact on PM1. 
 
While PM is not routinely assessed in traditional neuropsychological assessments4, there is 
evidence in the literature that PwMS experience reductions in this domain. Compared to healthy 
adults, PwMS have demonstrated significantly worse PM abilities5-8, particularly on time-based 
PM tasks6,9,10. These impairments have also been connected to real-world difficulties in PwMS. 
For instance, PM deficits in MS have been associated with unemployment11 and difficulty 
completing everyday functional activities9, including adherence to DMTs12 and attendance of 
MS-related appointments13. In addition, both objective and subjective PM have emerged as 
significant components of self-management behaviors14, which is important for handling the 
challenges associated with MS.    
 
Although there have been a number of cognitive-focused interventions in MS15, there has been 
limited work on improving PM in this population. Two experimental studies demonstrated that 
selective reminding16 and implementation intentions8 can improve performance on PM tasks. 
The latter technique, which involves 1) identifying the conditions where a task would be done 
and 2) visualizing doing so8, has been successful in other populations17. PM was also an 
exploratory outcome on a self-generation learning intervention, with contextual memory as the 
primary outcome18.  
 
Theoretically, improving a PwMS’ PM could have significant functional implications, such as 
improved adherence to DMTs and appointment attendance. However, while there have been 
successful PM interventions in other clinical populations, to date there has not been a specific 
PM intervention for PwMS that has been tested in a clinical trial4. In addition, evaluating a PM 
intervention in a telehealth format may increase access to cognitive rehabilitation services. 
Besides PwMS dealing with barriers to receiving healthcare services, such as mobility and 
accessibility19, COVID-19 has had a negative impact on referrals for cognitive remediation as 
well as other cognition-related services for PwMS20.   
 
2.0 
Rationale and Specific Aims 
 
Rationale: 

 
While PM deficits have been documented in MS5-10 and they have been associated with 
functional implications in this population9,11-14, there has yet to be a clinical trial focused on 
remediating PM difficulties among PwMS. Cognitive remediation is one of the most common 
treatments for cognitive dysfunction in MS: a recent survey of Consortium of MS Centers 
(CMSC) members found that nearly 61% refer their patients for this service, which is a 
significant increase from 201020,21. In addition, examining the feasibility and preliminary efficacy 
of this intervention in a telehealth format, which could increase who is able to access cognitive 
rehabilitation, may potentially have significant implications on patient care.  
 
This study aims to evaluate the feasibility of a PM intervention for PwMS, focusing on two types 
of strategies: visual imagery and implementation intentions. These strategies have been shown 
to be beneficial for improving PM in other populations17,22-24. Furthermore, they have been 
included in other cognitive-focused interventions for PwMS with success. For instance, visual 
imagery is a significant component of the modified Story Memory Technique intervention, which 
targets new learning and memory25-27. However, visual imagery has yet to be examined in 
PwMS for improving PM-related tasks (e.g., remembering to attend appointments or take 
medications) and there has yet to be an MS-specific intervention that utilizes both visual 
imagery and implementation intentions.   
 
Aims: 
 
Aim 1: Evaluate the feasibility of the telehealth PM intervention. 
 
A randomized pilot trial will be conducted to evaluate the feasibility of the intervention, with 
participants randomized to either the visual imagery and implementation intentions training (n 
= 18) or education control group (n = 18). 
Outcomes: Recruitment, enrollment, and retention numbers during the course of the study; 
participant-rated expectancy and credibility of the treatment program after the first session; 
adherence to sessions; and participant-related treatment satisfaction at post-treatment. 
Hypothesis: The majority of participants (≥75%) will complete at least two-thirds of the 
program and will report moderate-to-high (≥7 out of 10) treatment satisfaction, expectancy, 
and credibility. 
 
Aim 2: Establish the preliminary efficacy of the telehealth PM intervention. 
 
The same randomized pilot trial will be used to compare the intervention (n = 18) to the control 
(n = 18). 
Outcomes: The primary outcome will be objective PM abilities, as measured by the Memory for 
Intentions Test (MIST)28,29, which will be used to generate a preliminary effect size estimate for 
a future trial. A secondary outcome will be subjective PM abilities, as measured by the 
Perceived Deficits Questionnaire (PDQ) subscale30. 
Hypothesis: Compared to the control group, participants in the treatment group will exhibit an 
improvement in their PM abilities. In addition, the treatment group will endorse fewer PM 
difficulties. 

 
3.0 
Inclusion/Exclusion Criteria 
 
Inclusion Criteria:  
• 
Clinical diagnosis of MS 
• 
Able to read, write, and speak in English 
• 
Between the ages of 18 and 60 
• 
All genders 
• 
No history of other serious neurologic or psychiatric illness, including drug or alcohol 
misuse 
• 
No relapses within the past two months 
• 
Access to the Internet and a web camera 
• 
Not enrolled in a cognitive rehabilitation program within the past six months 
• 
Self-reported issues “remembering places they have to be” and “things they have to do” 
 
Exclusion Criteria: 
• 
No diagnosis of MS 
• 
Unable to complete the study protocol due to language barriers 
• 
Younger than 18 or older than 61 
• 
No gender exclusions 
• 
History of other serious neurologic or psychiatric illness, including drug or alcohol misuse 
• 
Had a relapse within the past two months 
• 
No access to the Internet and/or a web camera 
• 
Currently enrolled or enrolled in a cognitive rehabilitation program within the past six 
months 
• 
No self-reported issues with “remembering places they have to be” or “things they have 
to do” 
 
4.0 
Enrollment/Randomization 
 
The study will be conducted at the Mandell Center for MS (Mandell Center), which provides 
comprehensive care to persons with MS, thus allowing for easier recruitment of the intended 
patient population. As of December 31, 2019, 3,134 unique patients have been seen at the 
Mandell Center (M. Farr, personal communication, January, 23, 2020). Similar to the general MS 
population31, our patient population has more women than men (C. St Andre, personal 
communication, November 16, 2017). Patients range from age 18 to 88 (mean: 50.23 years) 
and are, on average, moderately disabled, as measured by the Expanded Disability Status Scale 
(EDSS) (mean: 3.8; range: 0-8.5)32 (C. St Andre, personal communication, November 16, 
2017). 
 
Participants will be primarily recruited through the Recruitment Pool for Studies at the Mandell 
Center for Multiple Sclerosis (IRB# MSH-19-48), an ongoing project where PwMS opt-in to be 
contacted about research opportunities at the Mandell Center. To date, there are over 400 
individuals who have agreed to be contacted about research studies being conducted at the 
Mandell Center. Potential participants will be contacted via email (with an IRB-approved 
recruitment letter) or via phone call. Recruitment flyers will also be posted in the Mandell 

Center, made available to staff, and distributed to the community. All recruitment materials will 
list the inclusion criteria and contact information. Prior to enrollment in the study, potential 
participants will be screened over the phone for the inclusion criteria. As the study is primarily 
being conducted via telehealth, we plan to have participants have minimal on-site visits.  
 
After completion of the baseline evaluations, participants will be randomized 1:1 into the 
treatment or control group, stratified by age and gender. A research assistance not involved in 
the data collection will be responsible for treatment allocation. This study will be single masked: 
different study personnel will be involved in the assessment and treatment portions of the 
study.  
 
5.0 
Study Procedures 
 
Baseline and Post-Treatment Assessments 
 
All participants (n = 36) will complete a baseline (week 1) and a post-treatment cognitive 
evaluation (week 6). These assessments will be conducted by Dr. Gromisch, a licensed 
neuropsychologist and research scientist at the Mandell Center with experience conducting 
cognitive-focused studies. Both the PM (active) and Education (control) groups will be receiving 
the same assessment measures at the same time points (see Figure 1 and Figure 2). 
 
Questionnaires:  
 
Demographics will be collected, including age, gender, race/ethnicity, disease duration, MS 
subtype, level of education, living situation and location, insurance type, and current DMT 
usage. Adherence to DMTs will be assessed with a single item, (“People often have difficulty 
taking their medications for one reason or another. How many times have you missed taking 
your DMT in the past month?”)33. Items about other functional tasks, such as driving, will be 
asked. Level of disability will be assessed using the Patient Determined Disease Steps (PDDS)34-
37 and MS symptoms will be measured using the SymptoMScreen38. All of these measures are 
included in the document TPMI Baseline Questionnaires. 
 
At baseline and post-treatment, both groups will complete the Perceived Deficits Questionnaire 
(PDQ)30, a 20-item self-report measure of cognitive functioning. While we will be primarily 
looking at subjective PM with the PM subscale, we will also collect participants’ reports on the 
three additional subscales (retrospective memory, attention, and planning/organization). This 
measure has been uploaded in the document PDQ for TPMI. 
 
At baseline and post-treatment, both groups will be given a Prospective Memory Diary39 
(document name: Memory-Diary). During the assessment sessions, Dr. Gromisch and the 
participant will identify five tasks and the participant will fill out how they carried out the task 
during the week (i.e., Week 1 following the baseline assessment and Week 6 following the post-
treatment assessment). These Prospective Memory Diaries will be mailed back or scanned and 
emailed back to the research team after they are completed. Participants will be provided with a 

pre-stamped return envelope, as well as a secure research email address 
(msresearch@TrinityHealthOfNE.org) if they prefer to scan and email. 
 
Neuropsychological Assessments: 
 
At the baseline and post-treatment assessments, participants will be completing a battery of 
neuropsychological measures. These are protected, copyrighted measures that are being 
purchased under Dr. Gromisch’s license and will only be administered, scored, and interpreted 
by Dr. Gromisch. All of these measures are standard neuropsychological measures frequently 
used in routine neuropsychological assessments. The measures being given are noted in the 
attached document TPMI Measure Checklist. No diagnoses of cognitive impairment will be 
made after either assessments, as this study is not part of clinical care.  
 
As these measures cannot be scanned and uploaded due to copyright restrictions and 
accordance with the American Psychological Association’s ethics code, details are provided 
below on each measure: 
 
Test of Premorbid Functioning (TOPF)40: is a measure of premorbid functioning. The participant 
reads aloud a list of words, which increase in complexity. The participant will only complete this 
measure at baseline. If a participant completed the TOPF in another study (i.e., MSH-21-09), 
they will not repeat the TOPF in this study as their scores are expected to remain stable over 
time.  
 
Memory for Intentions Test (MIST)28,29: is an eight-task objective measure of PM. The 
participant is given eight tasks over the course of the test at differing times, to which they must 
give a response at either a designated time or after a certain cue. The tasks in the MIST are 
meant to mimic everyday activities (e.g., recalling what medications they take). The participants 
are given one additional task with a 24-hour delay, in which they would call a secure research 
line (860-714-3005) and report how many hours of sleep they received the night before. The 
MIST will be given at baseline and post-treatment, and the total score will be used to calculate 
the preliminary effect size. To reduce learning effects, different versions of the MIST will be 
given at baseline and post-treatment. 
 
Neuropsychological Assessment Battery-Daily Living (NAB-DL) module41: is a battery of 
measures designed to mimic everyday functioning. There are five measures included (Driving 
Scenes, Bill Payment Daily Living, Daily Living Memory, Map Reading Daily Living, and Judgment 
Daily Living), which tap into memory, attention, and executive functioning. Participants will 
complete the NAB-DL module at the baseline and post-treatment assessments. To reduce 
learning effects, different versions of the NAB-DL will be given at baseline and post-treatment.  
 
Processing Speed Test (PST)42: is a digital version of the Symbol Digit Modalities Test designed 
for persons with MS. The PST taps into processing speed, as well as working memory. It will be 
administered on a Mandell Center iPad and none of the participant’s data are saved 
electronically (i.e., a score is generated but not saved, so it will be written down in the TPMI 
Measure Checklist). During the test, participants match up numbers to symbols as quickly as 

they can over a span of 120 seconds. Each time the PST is given, a randomized version is given 
to reduce learning effects. Participants will complete the PST at the baseline and post-treatment 
assessments.  
 
Trail Making Test (TMT)43: is a two-part test that measures psychomotor processing speed and 
executive functioning (i.e., set-shifting). In the first part, the participant draws a line connecting 
numbers 1-25 as quickly as they can. In the second part, the participant alternates between 
numbers and letters, going in order as quickly as they can, again connecting the items with a 
drawn line. Participants will complete the TMT at the baseline and post-treatment assessments. 
As only one version of the TMT has been normed with the Heaton-Reitan norms, the standard 
version will be used at both times. 
 
Digit Span44: is a measure of verbal attention and working memory. There are three parts. In 
the first part, a list of numbers are said in increasing order, which the participants repeats back 
verbatim. In the second part, a list of numbers are said in increasing order, but the participant 
must repeat them back in reverse order. In the third part, a list of numbers are said in 
increasing order, but the participant must repeat them back in chronological order. Participants 
will complete Digit Span at the baseline and post-treatment assessments. As there is only one 
version in the Wechsler Adult Intellegence Scale-Fourth Edition, the standard version will be 
used at both times. 
 
Test of Everyday Activity (TECA)45: is a timed measure of instrumental activities of daily living 
for persons living with MS. The participant is given a series of tasks and asked to complete 
them. These tasks are designed to mimic everyday activities (e.g., finding a number in a phone 
book and making change). Participants will complete the TECA at baseline only.  
 
Clock Drawing46: is a measure of visuospatial ability and executive functioning. The participant 
is asked to draw a clock, write in all the numbers, and set the time to “10 past 11.” In this 
version, the participant is not given any prompts (e.g., a pre-drawn clock face) and will only be 
given a blank piece of paper and a drawing instrument (i.e., a pencil). Participants will complete 
Clock Drawing at baseline only.   
 
 

 
 
Figure 1: Timeline of feasibility trial for PM (active intervention) group 
a Demographics related to inclusion criteria: age, diagnosis of MS, English-speaking, no history of other 
serious neurologic or psychiatric illness, no relapses within the past two months, access to the internet 
and a web camera, no cognitive remediation within the past six months, and reported difficulty 
remembering places they have to be and things they have to do 
b Age, gender, race/ethnicity, disease duration, MS subtype, education, living situation and location, 
insurance type, DMT usage and adherence, functional difficulties, Patient Determined Disease Steps, 
SymptoMScreen, and Test of Premorbid Functioning 
 
 
 
Figure 2: Timeline of feasibility trial for Education (control intervention) group 

a Demographics related to inclusion criteria: age, diagnosis of MS, English-speaking, no history of other 
serious neurologic or psychiatric illness, no relapses within the past two months, access to the internet 
and a web camera, no cognitive remediation within the past six months, and reported difficulty 
remembering places they have to be and things they have to do 
b Age, gender, race/ethnicity, disease duration, MS subtype, education, living situation and location, 
insurance type, DMT usage and adherence, functional difficulties, Patient Determined Disease Steps, 
SymptoMScreen, and Test of Premorbid Functioning 
 
During the course of the intervention, we will monitor for any changes in medication that may 
affect cognitive performance (e.g., opioids) as well as other health changes, but no changes in 
standard medical care will be done. 
 
Feasibility Measures 
 
In order to assess the feasibility of the intervention, we will be measuring 1) recruitment, 
enrollment, and retention; 2) adherence to the treatment; 3) treatment credibility and 
expectancy; and 4) treatment satisfaction. Enrollment will be tracked throughout the 
recruitment and study procedures, including 1) how many people were approached or 
expressed interest; 2) reasons people declined (including how many did not meet inclusion 
criteria); and 3) any drop-outs during the course of the trial and the reasons why. Throughout 
the treatment, we will be tracking participants’ attendance of their scheduled sessions. During 
the first session of both groups (week 2), participants will be asked to rate the credibility and 
expectancy for improvement from the intervention on a 10-point scale, with 10 indicating the 
highest level of credibility/expectancy47. Satisfaction will be measured post-treatment (week 6) 
using a scale of 0 (no satisfaction) to 10 (complete satisfaction) in terms of the overall 
treatment they received. Session adherence, treatment credibility and expectancy, and 
treatment satisfaction will be recorded on the uploaded document TPMI Feasibility Measure 
Collection Sheet.  
 
Treatment Groups 
 
Participants randomized to the PM intervention (active group) will meet with an interventionist 
twice a week for four weeks. Interventionists will be research assistants who will be added to 
the IRB of this study and supervised by Dr. Raskin, an expert in PM, with the materials based 
on her previous interventions in traumatic brain injury23. The first four sessions will focus on 
visual imagery, while the last four sessions will focus on implementation intentions. Participants 
will be led through a manualized treatment (Telehealth Prospective Memory 
Interventional Manual PM Group). The interventionists will also be using a standardized list 
of stimuli (PM Group Interventionist Packet). All participants will be receiving the same 
packet of training materials (PM Group Patient Packet and Implementation-Planner-
PDF), which will be given to them prior to the start of the telehealth sessions. As the sessions 
will be held via telehealth, participants will be mailed their training materials during Week 1 
after randomization and prior to the start of the intervention. To account for issues with mail, 
participants will also be sent a digital copy to their email from a secure research email 
(msresearch@TrinityHealthOfNE.org).    

 
The control group (Education) will meet with a research assistant for the same frequency of 
sessions and will receive psychoeducation on MS and cognitive functioning. The interventionists 
will be following a manual (Telehealth Prospective Memory Intervention Manual 
Education Group) and accompanying PowerPoint slides (TPMI Education_session 1-8). 
The Education group will not be receiving any additional materials.   
 
All sessions will be delivered via a video-based telehealth session using a HIPAA-compliant 
version of Qliqsoft. The interventionists will be using Trinity College lab computers which are 
password protected and encrypted or due to the current pandemic, interventionists may do the 
sessions off campus in a secure location (i.e., locked private room with headphones in on 
password protected computers. After each session, participants will be instructed to call 24 
hours later and report how many hours they slept the night before as a probe. Participants will 
be instructed to call 860-714-3005 which is a dedicated research line at the Mandell Center that 
only members of the research team will have access to.  
 
Consistent with previous studies conducted at the Mandell Center, a list of clinical resources, 
including behavioral health and neuropsychological services, will be made available to 
participants whose responses are suggestive of possible depression. This will also be available 
to any participant who expresses concern about their mood, level of anxiety, or cognition. The 
list of clinical resources will be provided at the end of the research appointment, and will 
explain how participants can get a referral to services through their provider. Community 
resources will also be noted on this handout.  
 
 
6.0 
Reporting of Adverse Events or Unanticipated Problems involving Risk to 
Participants or Others 
 
The Principal Investigator (PI) and the Institutional Review Board (IRB) have the authority to 
stop or suspend the study or require modifications. 
 
This protocol presents a slight increase over minimal risk to the participants and Unanticipated 
Problems Involving Risks to Participants or Others (UPIRPOs), including adverse events, are not 
anticipated. In the unlikely event that such events occur, Reportable Events (which are events 
that are serious or life-threatening and unanticipated (or anticipated but occurring with a 
greater frequency than expected) and possibly, probably, or definitely related) or UPIRPOs that 
may require a temporary or permanent interruption of study activities will be reported 
immediately (if possible), followed by a written report within 5 calendar days of the PI 
becoming aware of the event to the IRB (using the appropriate forms from the website) and 
any appropriate funding and regulatory agencies. The investigator will apprise fellow 
investigators and study personnel of all UPIRPOs and adverse events that occur during the 
conduct of this research project via email as they are reviewed by the principal investigator. 
 
The PI will be responsible for monitoring the data, assuring protocol compliance, and 
conducting safety reviews on a quarterly frequency. During the review process, the PI will 

evaluate whether the study should continue unchanged, require modification/amendment, or 
close to enrollment. 
 
7.0 
Study Withdrawal/Discontinuation 
 
A participant may withdraw from the study at anytime through written or verbal communication 
with a member of the research team. If a study participant stops participating in the study, the 
person will be notified that his/her participation in the study will be discontinued. Once notified 
of withdrawal or discontinuation, the participant will be immediately removed from the study 
and no further research appointments will occur.  
 
8.0 
Statistical Considerations 
 
For this project, we will be enrolling 36 participants (18 per arm). Fifteen participants has been 
previously identified as a sufficient sample size per treatment arm to calculate the sample size 
of a 90% powered main trial with a medium standardized difference48. An additional six 
individuals (three per treatment arm) will be included to account for a 20% attrition rate during 
the course of the trial. This sample size is adequate to detect a large effect size with 76% 
power and 5% significance on a one-tailed independent t-test. 
 
A flow diagram will be used to document recruitment, enrollment, and retention. Descriptive 
statistics will be used for adherence to treatment, and independent t-tests or Mann-Whitney U 
tests will be run for treatment credibility, expectancy, and satisfaction. For the preliminary 
efficacy calculations, an intent-to-treat approach will be used, with the expectation 
maximization (EM) approach to be used if justified by missing values analysis49. Cohen’s d effect 
size will be computed for the group difference and will be used to inform a definitive clinical 
trial.  
 
9.0 
Privacy/Confidentiality Issues 
 
There is a slight increase over minimal risk associated with this study. The measures being used 
to assess cognition are ones used by neuropsychologists as part of routine assessments, and 
the intervention materials mirror those used in cognitive rehabilitation or psychoeducation as 
part of clinical care. Minor inconvenience may occur during the completion of the assessments 
and intervention, which may be viewed as potentially frustrating, uncomfortable or distressing 
and time-consuming. If participants become distressed when discussing their cognition and its 
effects on their lives, they will be given the time in a private space to process their feelings. 
They will also have the option to discontinue answering any questions or the intervention. They 
will also be given alist of clinical resources if the participant expresses concern about their 
mood, level of anxiety, or cognition. These resources will be provided at the end of the research 
appointment, and will explain how participants can get a referral to services through their 
provider. Community resources will also be noted on this handout.  
 
 

Only authorized persons will have access to the information gathered in this study. Patient 
names or other identifiers such as social security number, initials, birth date, etc., will not be 
used to identify electronic records. Identifiable information will only be used for contacting 
participants for follow-up appointments, compensation, and verification of information in the 
medical records. A code number will be used to code the questionnaires. The code number will 
not be based on any information that could be used to identify the participant (for example, 
social security number, initials, birth date, etc.). Data that are published will in no way identify 
the individual participants or disclose their identities. 
 
10.0 Follow-up and Record Retention 
 
The study is anticipated to take one year to complete. During the study, all paper files will be 
stored in a locked file cabinet in the Research Department of the Mandell Center Computers at 
both the Mandell Center and Trinity College with research data will be password protected and 
encrypted to ensure confidentiality of participant records. All computers are password protected 
and encrypted. The PI will be ultimately responsible for the security of the information. After 
the study is closed and all data analysis is complete, records will be destroyed according to 
policies regarding length of time that research documents need to be retained after protocol 
completion.  
 
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