Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06375421
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-19
First Post:
2024-04-08
Brief Title:
Pilot and Feasibility of MEMI for Chronic Traumatic Brain Injury
Sponsor:
Vanderbilt University Medical Center
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
Development of Ecological Momentary Intervention for Memory in Chronic Traumatic Brain Injury A Pilot and Feasibility Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a pilot and feasibility study for a mobile phone-delivered intervention for memory called MEMI memory ecological momentary intervention that was designed to support adults with chronic traumatic brain injury with their memory The goal of the study is to examine the feasibility and acceptability of MEMI and to assess preliminary efficacy as to whether technology-delivered spaced memory retrieval opportunities improve memory in people with and without a history of chronic traumatic brain injury
Detailed Description:
Deficits in memory and learning are hallmark to traumatic brain injury TBI and limit a persons ability to participate in medical care benefit from therapy maintain positive social relationships and be successful at school or work There has been limited progress in the last several decades in advancing functional memory outcomes after TBI and constraints in the timing and context of the existing rehabilitation model may contribute In memory rehabilitation each opportunity to retrieve information strengthens that information in the neocortex and is thus both an assessment and a learning opportunity Increasing the contextual diversity of learning opportunities ie in the daily lives and contexts of patients may improve the rehabilitation potential of patients with TBI
This study is a pilot and feasibility trial of MEMI as a technology-delivered intervention that extends memory assessment and treatment over time and space We use a counterbalanced within-participant crossover design to examine MEMIs feasibility and acceptability in daily life and collect preliminary efficacy data as to how using MEMI in daily life affects long-term recall for participants with and without TBI The study includes a group of adults with a chronic history of moderate-severe TBI and a demographically matched control group Each participant uses MEMI for two weeks each in a different condition
Blocked Active Comparator Condition During one of the weeks participants will complete their initial learning session on the target words then immediately receive all of the exposures to each of the items in a single block They do not complete any more retrieval sessions until one week later when they complete a 15-minute test for their memory of all of the trained items
Spaced MEMI Intervention Condition During the other week participants complete their initial learning session and the subsequent retrieval sessions are spaced out over the course of the week two short retrieval sessions each day using MEMI Then they complete a 15-minute test for their memory of all of the trained items at the end of the week
This study addresses three aims
Aim 1 To examine the real-world feasibility and acceptability of MEMI via user engagement and survey data
Aim 2 To explore preliminary efficacy of spaced retrieval via MEMI to improve long-term word recall in individuals with and without chronic TBI
Aim 3 To explore how a spatial context and b temporal context of exposures affect long- term word recall in people with and without chronic TBI
This study is a pilot and feasibility trial of MEMI as a technology-delivered intervention that extends memory assessment and treatment over time and space We use a counterbalanced within-participant crossover design to examine MEMIs feasibility and acceptability in daily life and collect preliminary efficacy data as to how using MEMI in daily life affects long-term recall for participants with and without TBI The study includes a group of adults with a chronic history of moderate-severe TBI and a demographically matched control group Each participant uses MEMI for two weeks each in a different condition
Blocked Active Comparator Condition During one of the weeks participants will complete their initial learning session on the target words then immediately receive all of the exposures to each of the items in a single block They do not complete any more retrieval sessions until one week later when they complete a 15-minute test for their memory of all of the trained items
Spaced MEMI Intervention Condition During the other week participants complete their initial learning session and the subsequent retrieval sessions are spaced out over the course of the week two short retrieval sessions each day using MEMI Then they complete a 15-minute test for their memory of all of the trained items at the end of the week
This study addresses three aims
Aim 1 To examine the real-world feasibility and acceptability of MEMI via user engagement and survey data
Aim 2 To explore preliminary efficacy of spaced retrieval via MEMI to improve long-term word recall in individuals with and without chronic TBI
Aim 3 To explore how a spatial context and b temporal context of exposures affect long- term word recall in people with and without chronic TBI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None