NCT06187857

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2021

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 3, 2024

Completed
Last Updated

January 3, 2024

Status Verified

December 1, 2023

Enrollment Period

1.1 years

First QC Date

November 27, 2023

Last Update Submit

December 28, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Feasibility of study protocols.

    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 Outcomes (2)

  • Memory Outcomes: Repeatable Battery for Neuropsychological Status

    Through study completion, an average of 8 weeks.

  • Memory Outcomes: Ecological Memory Simulations

    Through study completion, an average of 8 weeks.

Interventions

Feasibility study of a virtually-delivered adaptation of an ecologically oriented neurorehabilitation of memory (EON-Mem) in improving memory for healthy older adults

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals 55 and older

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham Young Unversity

Provo, Utah, 84604, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: A feasibility study of twenty-five older adults completing the same virtual procedures.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 27, 2023

First Posted

January 3, 2024

Study Start

December 1, 2020

Primary Completion

December 20, 2021

Study Completion

December 20, 2021

Last Updated

January 3, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
The dataset will be published in January 2024 and will remain on the website.
More information

Available IPD Datasets

Study Protocol Access

Locations