Electronic Memory and Management Aid (EMMA)

Electronic Memory and Management Aid (EMMA) Web-based Training Evaluation for Older Adults Experiencing Memory Difficulties

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.

Study Overview

• Status: Recruiting
• Conditions: Mild Cognitive Impairment; Subjective Cognitive Complaints
• Intervention / Treatment: Behavioral: Personalized Web-based training for EMMA app; Behavioral: Motivational Interviewing: Clinician Support

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maggie Dines, B.S.; Phone Number: 1-509-335-4033; Email: margaret.dines@wsu.edu
• Study Contact Backup: Name: Maureen Schmitter-Edgecombe, PhD; Phone Number: 1-509-335-0170; Email: schmitter-e@wsu.edu

Study Locations

• United States
  • Washington
    • Pullman, Washington, United States, 99164-4820
      • Recruiting
      • Washington State University - Pullman; Study Remote
      • Contact: Maureen Schmitter-Edgecombe, PhD; Phone Number: 1-509-335-0170; Email: schmitter-e@wsu.edu
      • Contact: Magaret Dines, B.S.; Phone Number: 509-335-4033; Email: margaret.dines@wsu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.; 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.
Active Comparator: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in EMMA app use daily interactions	Total daily use interactions derived from the EMMA app will provide a measure of how much the app is being used.	continuous data collection through study completion up to 6 months
Change in Daily Assessment of Independent Living and Executive Skills (DAILIES)	To measure participants capacity to complete instrumental activities of daily living (IADLs) at home, participants complete a series of brief tasks that resemble typical IADLs (e.g., paying utility bills, running errands, filling out a rebate form) six days a week for three weeks (total score; range 0-93; higher scores indicate better performance).	at baseline and 6 month follow-up
Change in Cognitive Self-efficacy Questionnaire (CSEQ)	Self-report measure of a participants confidence in their everyday cognitive abilities (mean score; range 0-10; higher scores represent better self-reported confidence in cognitive abilities).	at baseline, immediately post-training and 6 month follow-up
Change in Patient-Reported Outcome Measurement Information System 29 general (PROMIS-29)	Self-report measure assessing a participants mental and physical health (T-score with mean of 50 and standard deviation of 10; higher scores represent worse symptomology)	at baseline, immediately post-training and 6 month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Coping Self-efficacy Scale (CSES)	Self-report measure of coping abilities (total score; range 1-130; higher scores represent greater self-perceived coping abilities)	at baseline, immediately post-training and 6 month follow-up
Change in Everyday Compensation questionnaire (Ecomp)	Self-report of everyday compensatory strategy use (mean score; range 0-4; higher scores represent better self-reported use of everyday compensatory strategies).	at baseline, immediately post-training and 6 month follow-up
Change in Patient-Reported Outcome Measurement Information (PROMIS) System Applied Cognition	Self-perception of cognitive abilities (T-score with mean of 50 and standard deviation of 10; higher scores represent worse symptomology).	at baseline, immediately post-training and 6 month follow-up
Change in Self-Efficacy for Appropriate Medication Use Scale (SEAMS)	Self-perception of medication management abilities (total score, range 13-39, higher scores are associated with greater self-efficacy for adherence to medications)	at baseline, immediately post-training and 6 month follow-up

Collaborators and Investigators

• Sponsor: Washington State University
• Collaborators: United States Department of Defense

Study record dates

Study Major Dates

• Study Start (Anticipated): January 20, 2023
• Primary Completion (Anticipated): May 20, 2024
• Study Completion (Anticipated): May 20, 2024

Study Registration Dates

• First Submitted: December 23, 2022
• First Submitted That Met QC Criteria: January 13, 2023
• First Posted (Estimate): January 24, 2023

Study Record Updates

• Last Update Posted (Estimate): January 24, 2023
• Last Update Submitted That Met QC Criteria: January 13, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: memory; health; quality of life; activities of daily living; time management; electronic aid
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: AZ190055

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Other researchers can request use of data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No