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Electronic Memory and Management Aid (EMMA)

Primary Purpose

Subjective Cognitive Complaints, Mild Cognitive Impairment

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Personalized Web-based training for EMMA app
Motivational Interviewing: Clinician Support
Sponsored by
Washington State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subjective Cognitive Complaints focused on measuring activities of daily living, memory, electronic aid, quality of life, health, time management

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Washington State University - Pullman; Study RemoteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Brief Clinician Motivational Support

Technology Support Only

Arm Description

Participants will learn to use the EMMA app through a personalized web-based training platform with brief weekly motivational support from a clinician.

Participants will learn to use the EMMA app through a personalized web-based training platform with technical support and reminders as needed.

Outcomes

Primary Outcome Measures

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.
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).
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).
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)

Secondary Outcome Measures

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)
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).
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).
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)

Full Information

First Posted
December 23, 2022
Last Updated
January 13, 2023
Sponsor
Washington State University
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT05696756
Brief Title
Electronic Memory and Management Aid
Acronym
EMMA
Official Title
Electronic Memory and Management Aid (EMMA) Web-based Training Evaluation for Older Adults Experiencing Memory Difficulties
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2023 (Anticipated)
Primary Completion Date
May 20, 2024 (Anticipated)
Study Completion Date
May 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington State University
Collaborators
United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subjective Cognitive Complaints, Mild Cognitive Impairment
Keywords
activities of daily living, memory, electronic aid, quality of life, health, time management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Brief Clinician Motivational Support
Arm Type
Experimental
Arm Description
Participants will learn to use the EMMA app through a personalized web-based training platform with brief weekly motivational support from a clinician.
Arm Title
Technology Support Only
Arm Type
Active Comparator
Arm Description
Participants will learn to use the EMMA app through a personalized web-based training platform with technical support and reminders as needed.
Intervention Type
Behavioral
Intervention Name(s)
Personalized Web-based training for EMMA app
Intervention Description
Participants will complete six sessions of training to support uptake and habit formation of EMMA app use with a personalized web-based training platform.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing: Clinician Support
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in EMMA app use daily interactions
Description
Total daily use interactions derived from the EMMA app will provide a measure of how much the app is being used.
Time Frame
continuous data collection through study completion up to 6 months
Title
Change in Daily Assessment of Independent Living and Executive Skills (DAILIES)
Description
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).
Time Frame
at baseline and 6 month follow-up
Title
Change in Cognitive Self-efficacy Questionnaire (CSEQ)
Description
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).
Time Frame
at baseline, immediately post-training and 6 month follow-up
Title
Change in Patient-Reported Outcome Measurement Information System 29 general (PROMIS-29)
Description
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)
Time Frame
at baseline, immediately post-training and 6 month follow-up
Secondary Outcome Measure Information:
Title
Change in Coping Self-efficacy Scale (CSES)
Description
Self-report measure of coping abilities (total score; range 1-130; higher scores represent greater self-perceived coping abilities)
Time Frame
at baseline, immediately post-training and 6 month follow-up
Title
Change in Everyday Compensation questionnaire (Ecomp)
Description
Self-report of everyday compensatory strategy use (mean score; range 0-4; higher scores represent better self-reported use of everyday compensatory strategies).
Time Frame
at baseline, immediately post-training and 6 month follow-up
Title
Change in Patient-Reported Outcome Measurement Information (PROMIS) System Applied Cognition
Description
Self-perception of cognitive abilities (T-score with mean of 50 and standard deviation of 10; higher scores represent worse symptomology).
Time Frame
at baseline, immediately post-training and 6 month follow-up
Title
Change in Self-Efficacy for Appropriate Medication Use Scale (SEAMS)
Description
Self-perception of medication management abilities (total score, range 13-39, higher scores are associated with greater self-efficacy for adherence to medications)
Time Frame
at baseline, immediately post-training and 6 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maggie Dines, B.S.
Phone
1-509-335-4033
Email
margaret.dines@wsu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Maureen Schmitter-Edgecombe, PhD
Phone
1-509-335-0170
Email
schmitter-e@wsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maureen Schmitter-Edgecombe, PhD
Organizational Affiliation
Washington State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington State University - Pullman; Study Remote
City
Pullman
State/Province
Washington
ZIP/Postal Code
99164-4820
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magaret Dines, B.S.
Phone
509-335-4033
Email
margaret.dines@wsu.edu
First Name & Middle Initial & Last Name & Degree
Maureen Schmitter-Edgecombe, PhD
Phone
1-509-335-0170
Email
schmitter-e@wsu.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Other researchers can request use of data

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Electronic Memory and Management Aid

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