A Virtually Delivered Memory Rehabilitation Protocol in Older Adults (EONMem_OA)

December 28, 2023 updated by: Whitney Allen, Brigham Young University

A Feasibility Study of a Virtually Delivered Ecologically Oriented Neurorehabilitation of Memory (EON-MEM) Protocol in Older Adults

The investigators conducted a feasibility study of a virtually-delivered adaptation of an ecologically oriented neurorehabilitation of memory (EON-Mem) in improving memory for healthy older adults. The primary purposes of this study included determining the feasibility of conducting EON-Mem virtually with older adults and whether a randomized control trial using EON-Mem in older adults is of value.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Twenty-five older adults aged 55 years and older were recruited for participation in the EON-Mem training program adapted and administered virtually. Measures of emotional functioning and cognitive functioning were administered before and following the intervention. Participants attended one virtual treatment session per week for a total of six weeks with daily homework assignments. A priori, feasibility was set at an 80% completion rate. To address questions regarding feasibility, the investigators calculated descriptive statistics on sample information.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • 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
    • Utah
      • Provo, Utah, United States, 84604
        • Brigham Young Unversity

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Individuals 55 and older

Exclusion Criteria:

  • Evidence of cognitive dysfunction on the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) as evidenced by a score of 3.3 or more
  • History of moderate-to-severe TBI
  • History of stroke
  • Dementia/neurological diagnoses
  • Current chemotherapy or radiation
  • Current or history of brain cancer
  • Poor sensory function including uncorrected vision, hearing, or speaking impairments that could interfere with learning the intervention, including nonnative English speakers.

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of study protocols.
Time Frame: Through study completion, an average of 8 weeks.
To address questions regarding feasibility, the investigators calculated descriptive statistics on sample information and feasibility was set a priori as a completion rate greater than 80% based on previous research.
Through study completion, an average of 8 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Memory Outcomes: Repeatable Battery for Neuropsychological Status
Time Frame: Through study completion, an average of 8 weeks.
To address secondary outcomes, the investigators calculated reliable change indices for memory outcomes on the Repeatable Battery for Neuropsychological Status. The reliable change indices vary from less than -1.96 to greater than 1.96. Greater than 1.96 represents improved memory functioning.
Through study completion, an average of 8 weeks.
Memory Outcomes: Ecological Memory Simulations
Time Frame: Through study completion, an average of 8 weeks.
To address secondary outcomes, the investigators calculated reliable change indices for memory outcomes on the Ecological Memory Simulations. The reliable change indices vary from less than -1.96 to greater than 1.96. Greater than 1.96 represents improved memory functioning.
Through study completion, an average of 8 weeks.

Collaborators and Investigators

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

Sponsor

Brigham Young University

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)

December 1, 2020

Primary Completion (Actual)

December 20, 2021

Study Completion (Actual)

December 20, 2021

Study Registration Dates

First Submitted

November 27, 2023

First Submitted That Met QC Criteria

December 28, 2023

First Posted (Actual)

January 3, 2024

Study Record Updates

Last Update Posted (Actual)

January 3, 2024

Last Update Submitted That Met QC Criteria

December 28, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • EONMem_OA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The investigators will be sharing study procedures, study design, and de-identified participant data on the Open Science Framework (OSF).

IPD Sharing Time Frame

The dataset will be published in January 2024 and will remain on the website.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Study Data/Documents

  1. Study Protocol

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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