Clinical trial NCT05129293: Improving Prospective Memory Via Telehealth
Official title: Improving Prospective Memory Via Telehealth: A Randomized Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: prospective memory
cognitive dysfunction
multiple sclerosis
Lead sponsor: Trinity Health Of New England
Sponsor class: OTHER
First posted: 2021-11-22
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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). 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.


Eligibility 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"

Primary outcomes:
measure: Memory for Intentions Test Total Score Percentile
timeFrame: Six weeks
measure: Memory for Intentions Test Time Cue Subscale Percentile
timeFrame: Six weeks
Secondary outcomes:
measure: Perceived Deficits Questionnaire-Prospective Memory Subscale
timeFrame: Six weeks
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Mount Sinai Rehabilitation Hospital
state: Connecticut
Study officials:
References: