Multiple SclerosisTPMINCT05129293
Improving Prospective Memory Via Telehealth
A study testing Prospective Memory Intervention and Educational in people with Multiple Sclerosis, run by Trinity Health Of New England at 1 site in United States.
Trial summary
Up to 70% of persons with multiple sclerosis (PwMS) experience cognitive impairment, which can have a significant impact on several aspects of their daily lives. One cognitive domain that has been shown to impact daily functioning, but is understudied in MS, is prospective memory (PM). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Prospective Memory Intervention and Educational
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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"
Who cannot join
- 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
Show all 9Show fewer
- 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"
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai Rehabilitation Hospital
Hartford, Connecticut, 06112
About this study
Official title: Improving Prospective Memory Via Telehealth: A Randomized Feasibility Trial
Up to 70% of persons with multiple sclerosis (PwMS) experience cognitive impairment, which can have a significant impact on several aspects of their daily lives. One cognitive domain that has been shown to impact daily functioning, but is understudied in MS, is prospective memory (PM). 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 trial.
The study will be a double-masked randomized feasibility trial, with 18 participants randomized to a PM intervention and 18 participants randomized to an active control (psychoeducation). Participants will meet with an interventionist twice a week for four weeks. Feasibility will be assessed via 1) recruitment, enrollment, and retention; 2) adherence to the treatment; 3) treatment credibility and expectancy; and 4) treatment satisfaction. A preliminary effect size (Cohen's d) will be computed for the group difference using participants' performance on the Memory for Intentions Test, which will be given at baseline (week 1) and post-treatment (week 6). Participants will also complete a battery of neuropsychological measures as part of their baseline and post-treatment assessments.
- Conditions
- Multiple Sclerosis
- Being tested
- Prospective Memory Intervention, Educational
- Keywords
- prospective memory, cognitive dysfunction, multiple sclerosis
- Medical subject headings
- Multiple Sclerosis, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prospective Memory InterventionBehavioural
Cognitive remediation focusing on prospective memory
EducationalBehavioural
Psychoeducation
| Study group | Role | What they receive |
|---|---|---|
| Prospective Memory Intervention | Experimental | Participants randomized to the PM intervention (active group) will meet with an interventionist twice a week for four weeks. 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. Receives: Behavioral: Prospective Memory Intervention |
| Educational | Active comparator | 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 and accompanying PowerPoint slides. Receives: Behavioral: Educational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Memory for Intentions Test Total Score Percentile
Performance on objective prospective memory (overall performance). The MIST Total Score is calculated by summing the raw scores from the six subscales, which is transformed into percentiles using age- and education-stratified normative data. Scores ranged from <1 9 (coded as 0 for analyses) to >99 (coded as 100 for analyses), with higher scores indicating better prospective memory performance.
Measured: Six weeks
Memory for Intentions Test Time Cue Subscale Percentile
Performance on objective prospective memory (time-based)
Measured: Six weeks
Secondary outcomes (1)
Perceived Deficits Questionnaire-Prospective Memory Subscale
Subjective prospective memory. The five items in the subscale are summed, with scores ranging between 0 and 20. Higher scores indicate more subjective prospective memory issues.
Measured: Six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start1 Nov 2021
- Primary completion5 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trinity Health Of New England
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129293
- Sponsor's protocol ID
- MSH 21-63
- Acronym
- TPMI
- Status last verified
- Oct 2024
- First submitted
- 10 Nov 2021
- Last updated
- 18 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Prospective Memory Via Telehealth: A Randomized Feasibility Trial
- ClinicalTrials.gov ID
- NCT05129293
- Acronym / sponsor ID
- TPMI / MSH 21-63
- Conditions
- Multiple Sclerosis
- Keywords
- prospective memory, cognitive dysfunction, multiple sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Trinity Health Of New EnglandUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 5 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 22 Nov 2021 (actual)
- Results
- Posted 18 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Up to 70% of persons with multiple sclerosis (PwMS) experience cognitive impairment, which can have a significant impact on several aspects of their daily lives. One cognitive domain that has been shown to impact daily functioning, but is understudied in MS, is prospective memory (PM). 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 trial.
The study will be a double-masked randomized feasibility trial, with 18 participants randomized to a PM intervention and 18 participants randomized to an active control (psychoeducation). Participants will meet with an interventionist twice a week for four weeks. Feasibility will be assessed via 1) recruitment, enrollment, and retention; 2) adherence to the treatment; 3) treatment credibility and expectancy; and 4) treatment satisfaction. A preliminary effect size (Cohen's d) will be computed for the group difference using participants' performance on the Memory for Intentions Test, which will be given at baseline (week 1) and post-treatment (week 6). Participants will also complete a battery of neuropsychological measures as part of their baseline and post-treatment assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective Memory Intervention | Experimental | Behavioral: Prospective Memory InterventionParticipants randomized to the PM intervention (active group) will meet with an interventionist twice a week for four weeks. 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. |
| Educational | Active comparator | Behavioral: EducationalThe 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 and accompanying PowerPoint slides. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prospective Memory InterventionCognitive remediation focusing on prospective memory | Behavioural | Prospective Memory Intervention |
| EducationalPsychoeducation | Behavioural | Educational |
Primary outcome
Memory for Intentions Test Total Score Percentile
Time frame: Six weeks
Performance on objective prospective memory (overall performance). The MIST Total Score is calculated by summing the raw scores from the six subscales, which is transformed into percentiles using age- and education-stratified normative data. Scores ranged from <1 9 (coded as 0 for analyses) to >99 (coded as 100 for analyses), with higher scores indicating better prospective memory performance.
Memory for Intentions Test Time Cue Subscale Percentile
Time frame: Six weeks
Performance on objective prospective memory (time-based)
1 secondary outcome
Perceived Deficits Questionnaire-Prospective Memory Subscale
Time frame: Six weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prospective Memory Intervention and Educational in people with Multiple Sclerosis, run by Trinity Health Of New England at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Memory for Intentions Test Total Score Percentile (time frame: Six weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.