Improving Prospective Memory Via Telehealth (TPMI)

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: Prospective Memory Intervention; Behavioral: Educational

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lindsay O Neto, MPH; Phone Number: 860-714-3005; Email: LNeto@TrinityHealthOfNE.org

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06112
      • Mount Sinai Rehabilitation Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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"

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prospective Memory Intervention; 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.	Behavioral: Prospective Memory Intervention; Cognitive remediation focusing on prospective memory
Active Comparator: Educational; 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.	Behavioral: Educational; Psychoeducation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Memory for Intentions Test	Performance on objective prospective memory	Six weeks

Collaborators and Investigators

• Sponsor: Trinity Health Of New England

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): June 5, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: November 10, 2021
• First Submitted That Met QC Criteria: November 10, 2021
• First Posted (Actual): November 22, 2021

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: multiple sclerosis; cognitive dysfunction; prospective memory
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: MSH 21-63

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No