Center for Research and Education on Aging and Technology Enhancement - CREATE V - Project 2
2 other identifiers
interventional
290
1 country
3
Brief Summary
The goal of this Stage 1 (NIH Stage Model) Intervention Development cross-site project is to develop, using a user-centered design approach, and evaluate an innovative intelligent adaptive software package aimed at providing cognitive and social support and engagement to older adults with mild cognitive impairment (MCI). The system will be designed to adapt to the needs and abilities of the user. The investigator's goal is to develop a unique and highly innovative technology tool that can provide adaptive support to aging individuals with MCI, even as cognition might deteriorate further. Speech data collected as part of an embedded reminiscence feature will advance fundamental knowledge of how speech and language production data might serve as an early indicator of cognitive decline.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2026
Shorter than P25 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2026
CompletedFirst Posted
Study publicly available on registry
March 20, 2026
CompletedStudy Start
First participant enrolled
August 31, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2027
Study Completion
Last participant's last visit for all outcomes
May 31, 2027
May 15, 2026
May 1, 2026
9 months
March 16, 2026
May 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Project 2, Phase 2: Perceived System Usability of the CAST Program as Measured by the number of times used per day
The CAST system or tablet usability will be assessed by evaluating participants' perception of the features of the system. Real time measures of the CAST system or tablet use will be evaluated, by the number of days used using the sum of times the system was used per day or the average, starting from baseline through six months. Measure is to be developed based on phase 1 of the study.
Baseline through 6 months
Project 2, Phase 2: Perceived System Usability of the CAST Program as measured by the number of times the system was used per day
The CAST system or tablet usability will be assessed by evaluating participants' perception of the features of the system. Real time measures of the CAST system or tablet use will be evaluated, using the sum of times the system was used per day or the average starting from baseline through six months. Measure is to be developed based on phase 1 of the study.
Baseline through 6 months
Project 2, Phase 2: Perceived System Usability of the CAST Program as measured by the number of features used per day
The CAST system or tablet usability will be assessed by evaluating participants' perception of the features of the system. Real time measures of the CAST system or tablet use will be evaluated, by number of features used per day, using the sum of numbers of features used per day or the average starting from baseline through six months. Measure is to be developed based on phase 1 of the study.
Baseline through 6 months
Project 2, Phase 2: Perceived Ease of Use of the CAST Program, assessed using the Perceived Ease of Use Questionnaire
Utilizing a 12-item scale (Perceived Ease of Use Questionnaire) which includes two subscales (perceived usefulness and perceived ease of use) with Likert response scales ranging from. 1 (Strongly disagree) - 10 (Strongly agree). The responses to the items are summed for each of the subscales. To assess ease of use, the investigators will evaluate responses to the perceived ease of use subscale.
6 months post intervention
Project 2, Phase 2: Perceived System Usefulness of the CAST Program, assessed using the Perceived Usefulness Questionnaire
Will assess participants' perception of technology-based intervention usefulness. Utilizing a 12-item scale (Perceived Usefulness Questionnaire) which includes two subscales (perceived usefulness and perceived ease of use) with Likert response scales ranging from. 0 (Strongly disagree) - 4 (Strongly agree). Higher sores indicate perceived ease of use of the CAST program. The responses to the items are summed for each of the subscales.
6-months post intervention
Project 2, Phase 2: Mean scores of participants' perception of CAST program usability and usefulness, assessed using the Usability Metric for user Experience (UMUX-Lite) questionnaire
Will assess participants' perception of technology-based intervention ease of use and usefulness. The Usability Metric for User Experience (UMUX-Lite) is a two-item Likert scale used for the subjective assessment of an application's perceived usability. On a 7- point scale, with 0 being strongly disagree and 6 being strongly agree, higher scores are reflective of a greater satisfaction with the system. The scoring range is from 0 to 14. A higher accumulated score is representative of a higher perception of usability.
6-months post intervention
Secondary Outcomes (5)
Project 2, Phase 2: Mean Difference in Score of Social Support and Connectivity Assessed using The Social Connectedness Measure
Baseline and 6 month post intervention
Project 2, Phase 2: Mean Difference in Score of Quality of Life, assessed using The Quality of Life Questionnaire
Baseline and 6 month post intervention
Project 2, Phase 2: Mean Difference in Score of reported depression, assessed using the Center for Epidemiological Studies-Depression (CES-D) Scale
Baseline and 6 month post intervention
Project 2, Phase 2: Mean Difference in score of participants self-reported health, assessed using the 36-Item Short Form Health Survey questionnaire (SF-36 Short Form)
Baseline and 6 month post intervention
Project 2, Phase 2: Mean Difference in scores of participants' perceived memory function, assessed using the Perception of Memory Function questionnaire
Baseline and 6 month post intervention
Study Arms (2)
Project 2 - Phase 2: Active Intervention Group
EXPERIMENTALParticipants will receive a tablet with the adaptive program and be provided with internet service following the baseline assessment. Participants will receive a 3-day training in their home that will include basic tablet/internet training and training on the features of the system. The training will also encompass a module on internet etiquette and security against potential spam and fraud. Participants will be provided with practice tasks in between sessions. Participants will be provided with a "hands-on" performance assessment at the end of the second session and concepts/procedures that are problematic will be reviewed.
Project 2 - Phase 2: Waitlist Control
ACTIVE COMPARATORParticipants will receive a 3-day training in their home. Participants will also receive a tablet, internet support for 12 months and training. This will include instructions for accessing content pertaining to the research study.
Interventions
An innovative intelligent adaptive software package aimed at providing social and cognitive support to older adults with MCI. The system will be designed to adapt to the needs and abilities of the user.
Eligibility Criteria
You may qualify if:
- + years of age
- Able to read English at the 6th grade level
- Have 20/60 vision with or without correction.
- Clinical diagnosis of mild cognitive impairment (MCI)
- Subjective cognitive complaints
- Evidence by clinical evaluation
- Clinical Dementia Rating Global scale of 0.5-2.0
- Probable MCI
- Montreal Cognitive Assessment (MoCA) score of 18-26
- No major Instrumental activities of daily living (IADL) impairments
- Geriatric Depression Scale of 4 or Below
- No diagnosis of dementia
You may not qualify if:
- Blind or have visual impairments that limit their ability to view the technology.
- Deaf or have hearing impairments that limit their ability to answer telephone queries.
- Have a life-limiting/terminal illness
- Severe motor impairment (e.g., severe tremors or debilitating arthritis in their hands) that impairs ability to speak or use dominant hand
- Cognitive impairment (MOCA ≤ 25)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Florida State University
Tallahassee, Florida, 32306, United States
University of Illinois Urbana-Champaign
Champaign, Illinois, 61820, United States
Weill Cornell Medicine
New York, New York, 10065, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sara J Czaja, PhD
Weill Medical College of Cornell University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2026
First Posted
March 20, 2026
Study Start (Estimated)
August 31, 2026
Primary Completion (Estimated)
May 31, 2027
Study Completion (Estimated)
May 31, 2027
Last Updated
May 15, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- The data from research projects will be made available no later than acceptance of publication of the main findings from the final data set. There is no end date to access the data from the research projects.
- Access Criteria
- The investigators agree to share the data with researchers working under an institution with Federal Wide Assurance who agree to a data sharing agreement that stipulates protection of participant privacy and data confidentiality, acknowledgement of CREATE, that the data will be used for research purposes only, and that the data will not be transferred to other users. The computerized data will include raw data, derived variables, all necessary documentation as described in the National Archive of Computerized Data on Aging depositor agreement. All data will be de-identified. The investigators will follow the guides published by the US Department of Health and Human Services in this respect. Each data set will include data documentation to ensure that others can use the data set and to minimize confusion. Information about where and how to locate and access the data will be available in any publications and presentations authored by CREATE investigators.
The investigators plan for resource sharing is based on the National Institutes of Health/National Institute on Aging (NIH/NIA) Data Sharing Policy. The investigators plan, consistent with the NIH goals of data sharing, is to promote use of the rich CREATE database by the larger research community as this will further the impact of CREATE and expand possibilities for collaboration. It will also allow other researchers to expedite the translation of the research findings into knowledge, products, and procedures. Further, the plan is devised to make the data as widely and freely available as possible while at the same time safeguarding the privacy of participants and protecting confidential and proprietary data.