Improving Prospective Memory Via Telehealth

Multiple Sclerosis Clinical Trial

— TPMI  

Official title:

Improving Prospective Memory Via Telehealth: A Randomized Feasibility Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05129293
• Other study ID #: MSH 21-63
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2023
• Source: Trinity Health Of New England
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: June 30, 2023
• Est. primary completion date: June 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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"

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Prospective Memory Intervention
Cognitive remediation focusing on prospective memory
• Educational
Psychoeducation

Locations

Country	Name	City	State
United States	Mount Sinai Rehabilitation Hospital	Hartford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Trinity Health Of New England

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Memory for Intentions Test	Performance on objective prospective memory	Six weeks