Electronic Memory and Management Aid (EMMA) Web-based Training Evaluation for Older Adults Experiencing Memory Difficulties
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in EMMA app use daily interactions
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be age 50 or older
- •Self-reporting subjective cognitive complaints (screening questions)
- •Must be able to read and speak English
排除标准
- •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
研究组 & 干预措施
Brief Clinician Motivational Support
Participants will learn to use the EMMA app through a personalized web-based training platform with brief weekly motivational support from a clinician.
干预措施: Personalized Web-based training for EMMA app (Behavioral)
Brief Clinician Motivational Support
Participants will learn to use the EMMA app through a personalized web-based training platform with brief weekly motivational support from a clinician.
干预措施: Motivational Interviewing: Clinician Support (Behavioral)
Technology Support Only
Participants will learn to use the EMMA app through a personalized web-based training platform with technical support and reminders as needed.
干预措施: Personalized Web-based training for EMMA app (Behavioral)
结局指标
主要结局
Change in EMMA app use daily interactions
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
次要结局
- 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)
研究者
Maureen-Schmitter-Edgecombe
Regents Professor
Washington State University