Electronic Memory and Management Aid

Mild Cognitive Impairment Clinical Trial

— EMMA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05696756
• Other study ID #: AZ190055
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2023
• Est. completion date: May 20, 2024

Study information

• Verified date: January 2023
• Source: Washington State University
• Contact: Maggie Dines, B.S.
• Phone: 1-509-335-4033
• Email: margaret.dines[@]wsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 20, 2024
• Est. primary completion date: May 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment
• Subjective Cognitive Complaints

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Washington State University - Pullman; Study Remote	Pullman	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Washington State University	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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