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Electronic Memory and Management Aid (EMMA)

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Washington State University

Status

Enrolling

Conditions

Mild Cognitive Impairment
Subjective Cognitive Complaints

Treatments

Behavioral: Personalized Web-based training for EMMA app
Behavioral: Motivational Interviewing: Clinician Support

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT05696756
AZ190055

Details and patient eligibility

About

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.

Full description

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.

Enrollment

50 estimated patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

Brief Clinician Motivational Support
Experimental group
Description:
Participants will learn to use the EMMA app through a personalized web-based training platform with brief weekly motivational support from a clinician.
Treatment:
Behavioral: Motivational Interviewing: Clinician Support
Behavioral: Personalized Web-based training for EMMA app
Technology Support Only
Active Comparator group
Description:
Participants will learn to use the EMMA app through a personalized web-based training platform with technical support and reminders as needed.
Treatment:
Behavioral: Personalized Web-based training for EMMA app

Trial contacts and locations

1

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Central trial contact

Maureen Schmitter-Edgecombe, PhD; Maggie Dines, B.S.

Data sourced from clinicaltrials.gov

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