Memory DysfunctionEONMem_OANCT06187857
A Virtually Delivered Memory Rehabilitation Protocol in Older Adults
A study testing Ecologically Oriented Neurorehabilitation of Memory (EON-Mem) in people with Memory Dysfunction and Neurorehabilitation, run by Brigham Young University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Memory Dysfunction, Neurorehabilitation
- What is being tested?
- Ecologically Oriented Neurorehabilitation of Memory (EON-Mem)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 20 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals 55 and older
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Memory Dysfunction, Neurorehabilitation
- Being tested
- Ecologically Oriented Neurorehabilitation of Memory (EON-Mem)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ecologically Oriented Neurorehabilitation of Memory (EON-Mem)Behavioural
Feasibility study of a virtually-delivered adaptation of an ecologically oriented neurorehabilitation of memory (EON-Mem) in improving memory for healthy older adults
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 8 weeks.
Secondary outcomes (2)
Memory Outcomes: Repeatable Battery for Neuropsychological Status
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.
Measured: Through study completion, an average of 8 weeks.
Memory Outcomes: Ecological Memory Simulations
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.
Measured: Through study completion, an average of 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start1 Dec 2020
- Primary completion20 Dec 2021
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Memory DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A feasibility study of twenty-five older adults completing the same virtual procedures.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham Young University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Whitney Allen, Brigham Young University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06187857
- Sponsor's protocol ID
- EONMem_OA
- Acronym
- EONMem_OA
- Status last verified
- Dec 2023
- First submitted
- 27 Nov 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will be sharing study procedures, study design, and de-identified participant data on the Open Science Framework (OSF).
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of a Virtually Delivered Ecologically Oriented Neurorehabilitation of Memory (EON-MEM) Protocol in Older Adults
- ClinicalTrials.gov ID
- NCT06187857
- Acronym / sponsor ID
- EONMem_OA / EONMem_OA
- Conditions
- Memory Dysfunction, Neurorehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Brigham Young UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 3 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- A feasibility study of twenty-five older adults completing the same virtual procedures.
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals 55 and older
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ecologically Oriented Neurorehabilitation of Memory (EON-Mem)Feasibility study of a virtually-delivered adaptation of an ecologically oriented neurorehabilitation of memory (EON-Mem) in improving memory for healthy older adults | Behavioural | – |
Primary outcome
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.
2 secondary outcomes
Memory Outcomes: Repeatable Battery for Neuropsychological Status
Time frame: Through study completion, an average of 8 weeks.
Memory Outcomes: Ecological Memory Simulations
Time frame: Through study completion, an average of 8 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Individual participant dataSharing planned: Yes. The investigators will be sharing study procedures, study design, and de-identified participant data on the Open Science Framework (OSF).
Related trials for Memory Dysfunction
Recruiting
HOBSCOTCH-MS-Efficacy Trial
Multiple Sclerosis, Cognitive Dysfunction
Recruiting
HOBSCOTCH-YOUTH and Young Adults
Epilepsy, Cognitive Dysfunction, Cognitive Disorder
Recruiting
Choose Myself (Before) Losing Myself
Dementia (Diagnosis), Mild Cognitive Impairment
Not yet recruiting
Deep Brain Stimulation Guided by Brain Mapping to Treat Cognitive Impairment
Mild Cognitive Impairment (MCI), Mild Cognitive Impairment (MCI) Amnestic
Active, not recruiting
Brain Boosters 2 in Persons at Risk for Alzheimer's Disease: a Digital Application Supported Intervention
Memory Disorders, Cognitive Impairment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ecologically Oriented Neurorehabilitation of Memory (EON-Mem) in people with Memory Dysfunction and Neurorehabilitation, run by Brigham Young University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of study protocols. (time frame: Through study completion, an average of 8 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024; AzTrials last refreshed its copy on 3 Nov 2026.