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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.
Deficits in memory and learning are hallmark to traumatic brain injury (TBI) and limit a person's 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 (i.e., 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 MEMI's 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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention, then Active Comparator | Other | Participants complete the Intervention (MEMI spaced retrieval) week, followed by the Active Comparator (blocked retrieval) week. |
|
| Active Comparator, then Intervention | Other | Participants complete the Active Comparator (blocked retrieval) week, followed by the Intervention (MEMI spaced retrieval) week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEMI (Memory Ecological Momentary Intervention) Spaced Retrieval | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability | Acceptability of Intervention Measure (4 = completely disagree/not acceptable - worse, 20 = completely agree/acceptable - better) | 1 week in each intervention condition |
| Feasibility (Engagement) | Number of possible sessions that participants complete in each condition (min: 0 - worse, max: 2 for Blocked and 12 for MEMI - better) | 1 week in each intervention condition |
| Measure | Description | Time Frame |
|---|---|---|
| Free Recall of Word Forms | Number of target word forms that participants type without cueing (0=did not remember any words- worse to 16=remembered all the words - better) | 1 week in each intervention condition |
| Cued Recall of Word Forms |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Spatial Contexts | At the beginning of each retrieval session, we ask participants to give their spatial context (the physical location in which they are completing the session, e.g., home or work). We report the number of different spatial contexts in which participants completed sessions in each condition. A higher number of spatial contexts indicates more variance in the contexts of retrieval opportunities, which is a goal of this technology (better). |
Inclusion criteria:
For participants with TBI:
For all participants:
Exclusion criteria:
For participants with TBI:
• History of medical or neurological disease affecting the brain or language, before or after the qualifying TBI.
For non-injured comparison peers:
• History of neurological or cognitive disability, including TBI
For all participants:
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| Name | Affiliation | Role |
|---|---|---|
| Emily Morrow, Ph.D. | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37203 | United States |
Individual participant data collected during the pilot trial will be de-identified and made available following publication of the results to researchers who provide a methodologically sound proposal.
Beginning 6 months after results publication. No end date.
Approval of a proposal by the study PI.
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With Traumatic Brain Injury (TBI): Intervention, Then Active Comparator | Participants complete the Intervention (MEMI spaced retrieval) week, followed by the Active Comparator (blocked retrieval) week. |
| FG001 | Non-Injured Comparison Participants: Intervention, Then Active Comparator | Participants complete the Intervention (MEMI spaced retrieval) week, followed by the Active Comparator (blocked retrieval) week. |
| FG002 | Participants With Traumatic Brain Injury (TBI): Active Comparator, Then Intervention | Participants complete the Active Comparator (blocked retrieval) week, followed by the Intervention (MEMI spaced retrieval) week. |
| FG003 | Non-injured Comparison Participants: Active Comparator, Then Intervention | Participants complete the Active Comparator (blocked retrieval) week, followed by the Intervention (MEMI spaced retrieval) week. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (1 Week) |
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| ||||||||||||||||||
| Second Intervention (1 Week) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With Traumatic Brain Injury (TBI) | Participants with TBI were in the chronic phrase (>6 months post-injury). TBI severity was moderate-severe per the Mayo Classification System. Participants were 18-55 years of age to exclude developmental effects of TBI and conservatively limit the effects of age-related cognitive decline. Participants with TBI had no other neurological or cognitive disabilities aside from the qualifying injury. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Acceptability | Acceptability of Intervention Measure (4 = completely disagree/not acceptable - worse, 20 = completely agree/acceptable - better) | Posted | Mean | Standard Deviation | score on a scale | 1 week in each intervention condition |
|
2 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants With Traumatic Brain Injury (TBI) Completing Intervention (MEMI Spaced Retrieval) | MEMI (Memory Ecological Momentary Intervention) Spaced Retrieval: 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. |
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Although participants were not incentivized for engagement, they were compensated for providing feedback on their experience. Participants may have been reluctant to provide critical feedback, but they were encouraged to provide their honest opinions.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Emily Morrow | Vanderbilt University Medical Center | 6153228392 | emily.morrow@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 2, 2024 | Dec 15, 2025 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 16, 2025 | Nov 10, 2025 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 9, 2024 | Dec 15, 2025 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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The order of conditions and the order of word list presentation will be counterbalanced. The order of condition/word list combination will be pre-determined, and participants will be assigned to the next available combination based on when they join the study (i.e., a counterbalanced within-person crossover design).
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|
| Blocked Retrieval | Behavioral | 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. |
|
Number of target word forms that participants remember in response to prompting (i.e., typing the word that labels a given image) (0=did not remember any words- worse to 16=remembered all the words - better)
| 1 week in each intervention condition |
| Cued Recall of Word Meanings | Number of target word definitions that participants remember in response to prompting (i.e., typing the definition for a given word) (0=did not remember any words- worse to 16=remembered all the words - better) | 1 week in each intervention condition |
| 1 week in each intervention condition |
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | Non-injured Comparison Participants | Comparison participants were also 18-55 years of age, had no history of neurological or cognitive disability, and were matched to the participants with TBI on age, sex, and education. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Educational Attainment | Mean | Standard Deviation | years |
|
MEMI (Memory Ecological Momentary Intervention) Spaced Retrieval: 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. |
| OG002 | Participants With Traumatic Brain Injury (TBI) Completing Active Comparator (Blocked Retrieval) | Blocked Retrieval: 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. |
| OG003 | Non-injured Comparison Participants Completing Active Comparator (Blocked Retrieval) | Blocked Retrieval: 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. |
|
|
| Primary | Feasibility (Engagement) | Number of possible sessions that participants complete in each condition (min: 0 - worse, max: 2 for Blocked and 12 for MEMI - better) | Posted | Mean | Standard Deviation | units on a scale | 1 week in each intervention condition |
|
|
|
| Secondary | Free Recall of Word Forms | Number of target word forms that participants type without cueing (0=did not remember any words- worse to 16=remembered all the words - better) | Posted | Mean | Standard Deviation | score on a scale | 1 week in each intervention condition |
|
|
|
|
| Secondary | Cued Recall of Word Forms | Number of target word forms that participants remember in response to prompting (i.e., typing the word that labels a given image) (0=did not remember any words- worse to 16=remembered all the words - better) | Posted | Mean | Standard Deviation | score on a scale | 1 week in each intervention condition |
|
|
|
|
| Secondary | Cued Recall of Word Meanings | Number of target word definitions that participants remember in response to prompting (i.e., typing the definition for a given word) (0=did not remember any words- worse to 16=remembered all the words - better) | Posted | Mean | Standard Deviation | score on a scale | 1 week in each intervention condition |
|
|
|
|
| Other Pre-specified | Number of Spatial Contexts | At the beginning of each retrieval session, we ask participants to give their spatial context (the physical location in which they are completing the session, e.g., home or work). We report the number of different spatial contexts in which participants completed sessions in each condition. A higher number of spatial contexts indicates more variance in the contexts of retrieval opportunities, which is a goal of this technology (better). | Posted | Mean | Standard Deviation | number of spatial contexts | 1 week in each intervention condition |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Non-Injured Comparison Participants Completing Intervention (MEMI Spaced Retrieval) | MEMI (Memory Ecological Momentary Intervention) Spaced Retrieval: 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. | 0 | 19 | 0 | 19 | 0 | 19 |
| EG002 | Participants With Traumatic Brain Injury (TBI) Completing Active Comparator (Blocked Retrieval) | Blocked Retrieval: 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. | 0 | 19 | 0 | 19 | 0 | 19 |
| EG003 | Non-injured Comparison Participants Completing Active Comparator (Blocked Retrieval) | Blocked Retrieval: 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. | 0 | 19 | 0 | 19 | 0 | 19 |
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| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| t-test, 2 sided |
degrees of freedom: 19 |
| <0.001 |
| Mean Difference (Net) |
| 6.8 |
| 2-Sided |
Preliminary Intervention Effect = MEMI Free Recall - Blocked Free Recall |
| Superiority |
For preliminary efficacy, we used paired-samples t-tests within each group to compare free recall at the 1-week assessment between the two schedules. |
| t-test, 2 sided |
degrees of freedom: 19 |
| <0.001 |
| Mean Difference (Net) |
| 5.3 |
| 2-Sided |
Preliminary Intervention Effect = MEMI Cued Word Recall - Blocked Cued Word Recall |
| Superiority |
We used paired-samples t-tests within each group to compare cued word recall at the 1-week assessment between the two schedules. |
|
| t-test, 2 sided |
degrees of freedom: 19 |
| 0.002 |
| Mean Difference (Net) |
| 3.3 |
| 2-Sided |
Preliminary Intervention Effect = MEMI Cued Definition Recall - Blocked Cued Definition Recall |
| Superiority |
We used paired-samples t-tests within each group to compare cued definition recall at the 1-week assessment between the two schedules. |