Electronic Memory and Management Aid

NCT05696756 | Unknown

• 1 other identifier: AZ190055
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Subjective Cognitive Complaints; Mild Cognitive Impairment

Keywords

activities of daily living; memory; electronic aid; quality of life; health; time management

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Change in Coping Self-efficacy Scale (CSES)

  at baseline, immediately post-training and 6 month follow-up

• Change in Everyday Compensation questionnaire (Ecomp)

  at baseline, immediately post-training and 6 month follow-up

• Change in Patient-Reported Outcome Measurement Information (PROMIS) System Applied Cognition

  at baseline, immediately post-training and 6 month follow-up

• Change in Self-Efficacy for Appropriate Medication Use Scale (SEAMS)

  at baseline, immediately post-training and 6 month follow-up

Study Arms (2)

Brief Clinician Motivational Support

EXPERIMENTAL

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; Behavioral: Motivational Interviewing: Clinician Support

Technology Support Only

ACTIVE COMPARATOR

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

Interventions

Personalized Web-based training for EMMA app 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.

Brief Clinician Motivational Support; Technology Support Only

Motivational Interviewing: Clinician Support 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.

Brief Clinician Motivational Support

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington State University: lead
• United States Department of Defense: collaborator

Study Sites (1)

Washington State University - Pullman; Study Remote

Pullman, Washington, 99164-4820, United States

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Maureen Schmitter-Edgecombe, PhD

  Washington State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maggie Dines, B.S.

CONTACT

1-509-335-4033; margaret.dines@wsu.edu

Maureen Schmitter-Edgecombe, PhD

CONTACT

1-509-335-0170; schmitter-e@wsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Regents Professor

Study Record Dates

• First Submitted: December 23, 2022
• First Posted: January 25, 2023
• Study Start: January 20, 2023
• Primary Completion: May 20, 2024
• Study Completion: May 20, 2024
• Last Updated: January 25, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)