Electronic Memory and Management Aid

NCT ID: NCT05696756

Last Updated: 2023-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-20

Study Completion Date

2024-05-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will evaluate the effectiveness of a personalized, web-based training intervention that was developed to teach use of an Electronic Memory and Management Aid (EMMA) application. The app-based system is designed to support everyday memory, daily activity management and positive health behavior engagement for older adults with subjective cognitive complaints or mild cognitive impairment. The investigators will also evaluate the degree to which a clinician is needed to oversee the uptake and utilization of the EMMA app during the web-based training intervention.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Participants will be randomly assigned to one of two groups, "Technical Support Only" group (T-only group) and "Technical + Clinician Support" group (T+C group). Participants will be enrolled in the study for 6 months.

Participants who pass initial phone screening criteria will participate in a 2-3 hour neurocognitive assessment over zoom to establish baseline cognition, prior to beginning the intervention. Participants will also complete questionnaires and a real-world measure assessing daily functioning. After the initial assessment is complete, participants will be given one-month to learn to use the EMMA app by completing the self-paced intervention via the adaptive, web-based training platform, which includes six lessons. EMMA device-use will be captured throughout the study by the app itself.

A component of the self-paced, web-based intervention involves setting goals related to using the EMMA app. A clinician will monitor the training data and goals the T+C group participants make and conduct brief problem-solving and goal-refining sessions during the intervention weeks. These sessions are expected to be 10-15 minutes. To keep training on track, the T-only group will receive brief phone check-ins to monitor progression through the web-based intervention. Following training, there will no longer be any differences in the treatment of both groups, which will be monitored for an additional three months. Immediately following training and at the end of the 3 month monitoring period, all participants will complete the battery of questionnaires and answer a semi-structured phone interview. In addition, at the end of the 3 month follow-up, all participants will again complete the neurocognitive assessment and real-world measure of daily functioning.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Subjective Cognitive Complaints Mild Cognitive Impairment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Brief Clinician Motivational Support

Participants will learn to use the EMMA app through a personalized web-based training platform with brief weekly motivational support from a clinician.

Group Type EXPERIMENTAL

Personalized Web-based training for EMMA app

Intervention Type BEHAVIORAL

Participants will complete six sessions of training to support uptake and habit formation of EMMA app use with a personalized web-based training platform.

Motivational Interviewing: Clinician Support

Intervention Type BEHAVIORAL

Participants will receive weekly brief check-ins with clinicians to motivate and support the problem-solving and habit formation aspects of the web-based training.

Technology Support Only

Participants will learn to use the EMMA app through a personalized web-based training platform with technical support and reminders as needed.

Group Type ACTIVE_COMPARATOR

Personalized Web-based training for EMMA app

Intervention Type BEHAVIORAL

Participants will complete six sessions of training to support uptake and habit formation of EMMA app use with a personalized web-based training platform.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Personalized Web-based training for EMMA app

Participants will complete six sessions of training to support uptake and habit formation of EMMA app use with a personalized web-based training platform.

Intervention Type BEHAVIORAL

Motivational Interviewing: Clinician Support

Participants will receive weekly brief check-ins with clinicians to motivate and support the problem-solving and habit formation aspects of the web-based training.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Must be age 50 or older
* Self-reporting subjective cognitive complaints (screening questions)
* Must be able to read and speak English

Exclusion Criteria

* Cannot provide own informed consent
* Have a known medical, neurological or psychiatric diagnosis that explains current cognitive complaints (e.g., stroke)
* Cannot complete remote study protocol due to severe vision or hearing difficulties
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

United States Department of Defense

FED

Sponsor Role collaborator

Washington State University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Maureen-Schmitter-Edgecombe

Regents Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Maureen Schmitter-Edgecombe, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington State University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Washington State University - Pullman; Study Remote

Pullman, Washington, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Maggie Dines, B.S.

Role: CONTACT

1-509-335-4033

Maureen Schmitter-Edgecombe, PhD

Role: CONTACT

1-509-335-0170

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Magaret Dines, B.S.

Role: primary

509-335-4033

Maureen Schmitter-Edgecombe, PhD

Role: backup

1-509-335-0170

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AZ190055

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.