Clinical trial NCT05696756: Electronic Memory and Management Aid
Official title: Electronic Memory and Management Aid (EMMA) Web-based Training Evaluation for Older Adults Experiencing Memory Difficulties
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Subjective Cognitive Complaints
Mild Cognitive Impairment
Keywords: activities of daily living
memory
electronic aid
quality of life
health
time management
Lead sponsor: Washington State University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2023-01-25
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in EMMA app use daily interactions
timeFrame: continuous data collection through study completion up to 6 months
measure: Change in Daily Assessment of Independent Living and Executive Skills (DAILIES)
timeFrame: at baseline and 6 month follow-up
measure: Change in Cognitive Self-efficacy Questionnaire (CSEQ)
timeFrame: at baseline, immediately post-training and 6 month follow-up
measure: Change in Patient-Reported Outcome Measurement Information System 29 general (PROMIS-29)
timeFrame: at baseline, immediately post-training and 6 month follow-up
Secondary outcomes:
measure: Change in Coping Self-efficacy Scale (CSES)
timeFrame: at baseline, immediately post-training and 6 month follow-up
measure: Change in Everyday Compensation questionnaire (Ecomp)
timeFrame: at baseline, immediately post-training and 6 month follow-up
measure: Change in Patient-Reported Outcome Measurement Information (PROMIS) System Applied Cognition
timeFrame: at baseline, immediately post-training and 6 month follow-up
measure: Change in Self-Efficacy for Appropriate Medication Use Scale (SEAMS)
timeFrame: at baseline, immediately post-training and 6 month follow-up
Other outcomes:
Locations:
city: Pullman
country: United States
facility: Washington State University - Pullman; Study Remote
state: Washington
Study officials:
affiliation: Washington State University
name: Maureen Schmitter-Edgecombe, PhD
role: PRINCIPAL_INVESTIGATOR
References: