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Clinical Trials/NCT05696756
NCT05696756
Recruiting
Not Applicable

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

Washington State University1 site in 1 country50 target enrollmentJanuary 20, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Subjective Cognitive Complaints
Sponsor
Washington State University
Enrollment
50
Locations
1
Primary Endpoint
Change in EMMA app use daily interactions
Status
Recruiting
Last Updated
3 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
January 20, 2023
End Date
May 20, 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Maureen-Schmitter-Edgecombe

Regents Professor

Washington State University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in EMMA app use daily interactions

Time Frame: continuous data collection through study completion up to 6 months

Total daily use interactions derived from the EMMA app will provide a measure of how much the app is being used.

Change in Daily Assessment of Independent Living and Executive Skills (DAILIES)

Time Frame: at baseline and 6 month follow-up

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).

Change in Cognitive Self-efficacy Questionnaire (CSEQ)

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

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).

Change in Patient-Reported Outcome Measurement Information System 29 general (PROMIS-29)

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

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)

Secondary Outcomes

  • 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 Sites (1)

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