Everyday Memory Intervention (EMMI)

April 3, 2024 updated by: Georgia Institute of Technology

Enhancing Older Adults' Everyday Memory Function

Evaluates an intervention designed to improve everyday memory function, contrasting people receiving the intervention with a group that receives traditional memory strategy training.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This project seeks to develop and validate a novel approach to training everyday memory functioning in older adults. The approach (1) trains people to use simple but effective memory skills that have broad applicability in everyday life and (2) shapes a set of skills and habits of mind that will increase the likelihood of effective use of skills and memory aids. It is based on a metacognitive perspective on self-regulation in cognitively demanding situations and informed by recent theories about how suboptimal habit patterns can be altered. The approach has not yet been used in an everyday memory intervention in high-functioning, community-dwelling older adults. The proposed research validates ecological momentary assessment methods to get actual behavioral measures of forgetting in everyday life. It then uses these procedures in a randomized experiment that contrasts the everyday memory intervention group with a traditional memory-strategy training group. The hypothesis is that the everyday memory training intervention will reduce everyday memory errors and memory complaints, whereas the memory strategy training will alter strategy use and memory performance, with little cross-over effect. The hypothesized pattern will establish the explicit benefits of our everyday memory intervention procedures and demonstrate the limitation of standard memory training for that purpose.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30332
        • Adult Cognition Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

70 years to 85 years (Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 70 - 85 years of age
  • in fair to good health
  • free of major neurocognitive impairment
  • English speaking
  • endorsed Smartphone and computer users (or willing to learn)

Exclusion Criteria:

  • diagnosis of any major neurological problems (e.g. stroke, Parkinson's disease, dementia)
  • 1.5 SD below age-normed mean (or lower) on the TICS
  • low computer and smart phone literacy
  • and poor self-rated health.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Everyday Metacognitive Memory
Training in techniques for managing memory demands in everyday life
Behavioral: Everyday Metacognitive Memory Intervention
Provides training in use of techniques and procedures to enhance proactive self-regulatory control over everyday memory demands, including strategies for learning information, planning for meeting everyday goals, and monitoring of efficacy of goal pursuit.
Active Comparator: Memory Strategy Control
Trains the use of memory strategies for learning new associations and concepts
Behavioral: Memory Strategy Control Intervention
Trains use of standard mnemonic techniques such as imagery and sentence generation for learning new associations and organizational and distinctiveness-based strategies for learning sets of items (e.g., word lists).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Everyday Memory Failures
Time Frame: minimum 8 day period after training on app prior to posttest
Across the data collection period, participants audio recorded descriptions of their memory failures on a smartphone app. The audio recordings were transcribed and then cleaned and qualitatively coded so that the number of memory failures each participant reported during the data collection period could be counted. The data was qualitatively coded to ensure an accurate count of the number of memory failures per participant without counting duplicate events or accidental reports. Average daily number of reported memory failures from EMA & daily diaries is reported.
minimum 8 day period after training on app prior to posttest
Prospective Memory Lab Contacts
Time Frame: Two weeks prior to posttest
Number of successfully completed lab contacts (maximum of 4)
Two weeks prior to posttest
Prospective Memory Lab Contact Efficiency
Time Frame: Two weeks prior to posttest
median absolute time deviation (in minutes) from scheduled lab contact for completed contacts
Two weeks prior to posttest
Everyday Cognition Simulation Task: ATM Task (Number of Errors)
Time Frame: posttest only
Computerized task to simulate use of an ATM machine. Measure: number of errors
posttest only
Czaja Everyday Cognition Simulation Task: Prescription Refill Task (Number of Errors)
Time Frame: posttest only
Computerized task to simulate use of an automated telephone program to refill prescriptions. Measure: Number of errors
posttest only
Free Recall Test
Time Frame: pretest and posttest (approximately 1 month lag)
Computerized task to present 30 concrete nouns, 6 from 5 taxonomic categories (Hultsch, Hertzog, Dixon, & Small, 1998) Measure is proportion of 30 words recalled
pretest and posttest (approximately 1 month lag)
Associative Recall Test
Time Frame: pretest and posttest (approximately 1 month lag)
Computerized task to present 40 concrete-concrete associatively unrelated noun pairs (Hertzog, Sinclair, & Dunlosky, 2010) Outcome is proportion of 40 words correctly recalled.
pretest and posttest (approximately 1 month lag)
Story Recall
Time Frame: posttest only
gist recall of narrative story (total number of propositions (ideas) from story recalled)
posttest only
Everyday Cognition Simulation Task: ATM Task (Time in Seconds)
Time Frame: posttest only
Computerized task to simulate use of an ATM machine. Measure: time to complete task (in seconds)
posttest only
Czaja Everyday Cognition Simulation Task: Prescription Refill Task (Time in Seconds)
Time Frame: posttest only
Computerized task to simulate use of an automated telephone program to refill prescriptions. Measure: time to complete task (in seconds)
posttest only

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
MFQ Memory Complaint (Frequency of Forgetting Scale)
Time Frame: pretest and posttest (approximately 1 month lag)
Summative Likert scale measuring frequency of reported memory problems for specific types of problems Measure is average item Likert rating on a 1-7 scale. Higher score indicates fewer memory problems
pretest and posttest (approximately 1 month lag)
PBMI Specific Memory Self-Efficacy
Time Frame: pretest and posttest (approximately 1 month lag)
The Personal Beliefs about Memory Instruments (PBMI) Specific Memory Self-Efficacy measurement is a summative visual analog rating scale measuring self-rated memory aggregated over multiple specific types of memory. Outcomes scaled in average proportion of distance from left (0) to maximum of 1.00 (higher scores indicate greater memory self-efficacy).
pretest and posttest (approximately 1 month lag)
PBMI Memory Control
Time Frame: pretest and posttest (approximately 1 month lag)
Summative visual analog rating scale measuring self-rated control over everyday. Outcome is scaled as average proportion of maximum endorsement (ranging from 0 to 1.0, with higher scores indicate greater perceived control)
pretest and posttest (approximately 1 month lag)
MCQ Internal Scale
Time Frame: pretest and posttest (approximately 1 month lag)
Summative Likert scale obtaining self-rated frequency of use of internal mnemonic strategies in everyday life. Average Likert rating on 1-5 scale (higher scores indicate greater use of strategies)
pretest and posttest (approximately 1 month lag)
MCQ External
Time Frame: pretest and posttest (approximately 1 month lag)
Summative Likert scale obtaining self-rated frequency of use of external memory aids. Outcome is scaled as average Likert rating on 1-5 scale. Higher score indicates greater use of external aids.
pretest and posttest (approximately 1 month lag)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Georgia Institute of Technology

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Aging (NIA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christopher Hertzog, Ph.D, Georgia Institute of Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 10, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 10, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 11, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 12, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H19341
  • 1R21AG059942-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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