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Improving Prospective Memory Via Telehealth (TPMI)

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prospective Memory Intervention
Educational
Sponsored by
Trinity Health Of New England
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring prospective memory, cognitive dysfunction, multiple sclerosis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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"

Sites / Locations

  • Mount Sinai Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Prospective Memory Intervention

Educational

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Memory for Intentions Test
Performance on objective prospective memory

Secondary Outcome Measures

Full Information

First Posted
November 10, 2021
Last Updated
July 31, 2023
Sponsor
Trinity Health Of New England
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1. Study Identification

Unique Protocol Identification Number
NCT05129293
Brief Title
Improving Prospective Memory Via Telehealth
Acronym
TPMI
Official Title
Improving Prospective Memory Via Telehealth: A Randomized Feasibility Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
June 5, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Trinity Health Of New England

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
prospective memory, cognitive dysfunction, multiple sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prospective Memory Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Educational
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Prospective Memory Intervention
Intervention Description
Cognitive remediation focusing on prospective memory
Intervention Type
Behavioral
Intervention Name(s)
Educational
Intervention Description
Psychoeducation
Primary Outcome Measure Information:
Title
Memory for Intentions Test
Description
Performance on objective prospective memory
Time Frame
Six weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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"
Facility Information:
Facility Name
Mount Sinai Rehabilitation Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06112
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Improving Prospective Memory Via Telehealth

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