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临床试验/NCT06375421
NCT06375421已完成不适用

Development of Ecological Momentary Intervention for Memory in Chronic Traumatic Brain Injury: A Pilot and Feasibility Study

Vanderbilt University Medical Center1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年4月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Acceptability

研究概览

简要总结

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.

详细描述

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:

  • 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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • For participants with TBI:
  • Moderate-severe TBI. All participants were determined to have a history of moderate-severe TBI upon joining the Vanderbilt Brain Injury Patient Registry. This determination was made based on the Mayo Classification Scale.
  • All participants are at least 6 months post-injury at the time of study enrollment and thus exhibit chronic and stable neuropsychological profiles.
  • Age ranging from 18-60, to rule out developmental TBI and limit influence of age-related cognitive decline.
  • For all participants:
  • Oral and written language skills sufficient for the study tasks. This will be screened in the initial video conference contact with the participant, when consent is obtained.
  • Participants must own a smartphone to access the Gorilla online behavioral experiment platform from their mobile phones.

排除标准

  • 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:
  • Any disability (e.g., vision impairment, hard of hearing, aphasia or other neurologic condition) that limits ability to read, type, or verbally communicate.
  • Demonstrates inability to receive and respond to a text message after training by study personnel.

研究组 & 干预措施

Intervention, then Active Comparator

Other

Participants complete the Intervention (MEMI spaced retrieval) week, followed by the Active Comparator (blocked retrieval) week.

干预措施: MEMI (Memory Ecological Momentary Intervention) Spaced Retrieval (Behavioral)

Intervention, then Active Comparator

Other

Participants complete the Intervention (MEMI spaced retrieval) week, followed by the Active Comparator (blocked retrieval) week.

干预措施: Blocked Retrieval (Behavioral)

Active Comparator, then Intervention

Other

Participants complete the Active Comparator (blocked retrieval) week, followed by the Intervention (MEMI spaced retrieval) week.

干预措施: MEMI (Memory Ecological Momentary Intervention) Spaced Retrieval (Behavioral)

Active Comparator, then Intervention

Other

Participants complete the Active Comparator (blocked retrieval) week, followed by the Intervention (MEMI spaced retrieval) week.

干预措施: Blocked Retrieval (Behavioral)

结局指标

主要结局

Acceptability

时间窗: 1 week in each intervention condition

Acceptability of Intervention Measure (4 = completely disagree/not acceptable - worse, 20 = completely agree/acceptable - better)

Feasibility (Engagement)

时间窗: 1 week in each intervention condition

Number of possible sessions that participants complete in each condition (min: 0 - worse, max: 2 for Blocked and 12 for MEMI - better)

次要结局

  • Free Recall of Word Forms(1 week in each intervention condition)
  • Cued Recall of Word Forms(1 week in each intervention condition)
  • Cued Recall of Word Meanings(1 week in each intervention condition)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Emily Morrow

Postdoctoral Research Fellow

Vanderbilt University Medical Center

研究点 (1)

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