Maintaining Cognitive Health in Aging Veterans

February 27, 2019 updated by: VA Office of Research and Development
Interventions aimed at disseminating information about cognitive aging and lifestyle factors that contribute to successful cognitive aging, in addition to providing broad cognitive skills training, may improve the psychological wellness and day-to-day functioning of the aging Veteran population. This 12-week course aims to teach older Veterans (age 50+) about brain aging, lifestyle factors that contribute to successful aging, and techniques that can boost cognition in daily life.

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

The proportion of Veterans over age 65 has risen from 11% to 26% from 1980 to 1990, and is estimated to rise to over 50% by 2030. Due to the growing number of older Veterans, health issues specific to the aging Veteran population is a primary concern for the Veterans Health Administration. Fear of developing dementia is common among older adults and minor memory lapses that were previously of little concern may be misinterpreted as signaling the beginning stages of dementia. Although normal cognitive aging is not the same as pathological aging, the impact of normal age-related changes warrants intervention since it can cause emotional distress and functional difficulties impacting occupational, recreational, and social pursuits and subjective cognitive impairment, defined as a noticed cognitive change without objective evidence of decline on neuropsychological testing may be the earliest precursor for dementia. While cognitive changes can be expected as we age, there is a growing body of literature demonstrating that modifiable lifestyle factors can influence functional ability and quality of life as one ages. In addition, cognitive training may result in improvements in cognition and functioning in older adults. Unfortunately, many older adults lack knowledge about cognitive aging and the factors that contribute to successful cognitive aging, which limits their ability to make changes that can improve the odds of successful cognitive aging. The need to disseminate information related to brain health has recently been recognized by key agencies involved in promoting the welfare of older adults, including the National Institutes of Neurological Disorders and Stroke, Mental Health, and Aging as well as the Centers for Disease Control and Prevention and the Alzheimer's Association. The current study builds upon previous work on cognitive intervention in older adults by investigating a multi-component intervention which includes psychoeducation about cognitive aging, presentation of lifestyle factors that contribute to successful cognitive aging, and broad cognitive skills training. Using a randomized controlled trial design, 72 Veterans will be assigned to either the intervention group (36) or a no treatment control group (36). Veterans will undergo baseline assessment, which will be used for comparison immediately following the intervention and at 3 and 6 month followup. Outcomes include knowledge of cognitive aging, measures of psychological wellness, and indicators of cognitive and functional ability.

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.
50

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
    • Massachusetts
      • Bedford, Massachusetts, United States, 01730
        • Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

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

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Veterans age 50 and older who are concerned about their memory.
  • Veterans age 50 and older who want to learn about memory processes.

Exclusion Criteria:

Participants will be excluded if they display impairment on a cognitive screening measure, as determined using age and education corrected criteria with a minimum 90% specificity (using criteria: Schretlen, Testa, and Pearlson, 2010) as follows:

  • Age Education MMSE Cut-off Specificity Sensitivity
  • 51-55 / 26 or <
  • 56-60 / 25 or <
  • 61-65 / 25 or <
  • 66-70 / 25 or <
  • 71-75 / 23 or <
  • 76-80 / 23 or <
  • 86+ / 22 or <
  • Or self or informant reported diagnosis of a brain disorder affecting cognition such as Alzheimer's disease, Mild Cognitive Impairment, Parkinson's disease, other dementia, stroke, or brain injury or diagnosis of a major mental illness such as major depression, schizophrenia, or bipolar disorder; active alcohol or substance abuse.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group 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.
Other: Intervention
12-week course on memory and aging, consists of psychoeducation and skills training
Other: Memory and Aging Course
This is a 12-week course that will provide participants with an understanding of what normal and pathological aging processes look like. It will also provide participants with methods to maintain healthy lifestyles as they continue to grow older.
No Intervention: Control, No Intervention
No Intervention, considered "treatment as usual"

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
Knowledge of Memory Aging Questionnaire-Revised
Time Frame: Within 1 week of start of program
Measures laypersons' knowledge of memory changes in adulthood for research or educational purposes using true/false/"don't know" questions, with half of the questions pertaining to normal memory aging and the other half covering pathological memory deficits due to non-normative factors, such as dementia. Test-retest reliability and convergent and discriminant validity were established at adequate levels. Minimum value is 0, maximum value is 28, higher scores indicate better knowledge of memory aging.
Within 1 week of start of program

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
Multifactorial Memory Questionnaire (MMQ)
Time Frame: Within 1 week of start of program
The MMQ is a measure constructed to reflect aspects of memory that are potentially amenable to clinical intervention. The scale consists of three subscales - memory contentment, memory ability, and memory strategy use. Higher scores indicate, respectively, greater contentment, ability, and strategy use. Minimum 0, maximum 80
Within 1 week of start of program

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.
VA Office of Research and Development

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: Maureen O'Connor, PsyD, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

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.
November 1, 2013

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.
November 1, 2017

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.
November 1, 2017

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).
December 24, 2013

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.
December 24, 2013

First Posted (Estimate)

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.
December 30, 2013

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 31, 2019

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.
February 27, 2019

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.
February 1, 2019

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.
  • E1389-P

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

product manufactured in and exported from the U.S.

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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