Center for Research and Education on Aging and Technology Enhancement - CREATE V - Project 2

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorWeill Medical College of Cornell University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

62+ 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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Project 2, Phase 2: Intelligent Adaptive System

    Behavioral

    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.

Treatment groups

290 Participants
are divided into 2 treatment groups
Group A: Project 2 - Phase 2: Active Intervention GroupExperimental treatment 1 intervention
Group B: Project 2 - Phase 2: Waitlist ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline through 6 months
2

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.

Time frame
Baseline through 6 months
3

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.

Time frame
Baseline through 6 months
4

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.

Time frame
6 months post intervention

Secondary outcomes

1

Project 2, Phase 2: Mean Difference in Score of Social Support and Connectivity Assessed using The Social Connectedness Measure

Scales used to measure two aspects of social isolation: social disconnectedness and perceived isolation, as well as perceived availability of social support. The Social Connectedness measure is a 15-item scale consisting of 3 sections with different likert response scale. Section 1 is a 4-item scale ranging from 0 - 5 points (20 total points). Section 2 is a 6-item scale ranging from 1 - 3 points (18 total points). Section 3 is a 5-item scale ranging from 1 - 5 points (25 total points). For Section 1, a higher score is reflective of increased connectedness while for Section 2 and 3, a higher score is a reflective of a higher level of disconnectedness. For sections 1-3, a mean difference in score will be calculated.

Time frame
Baseline and 6 month post intervention
2

Project 2, Phase 2: Mean Difference in Score of Quality of Life, assessed using The Quality of Life Questionnaire

Will assess the participant's quality of life by having the participant rate different aspects of their life using one of four words: poor, fair, good, or excellent. They are instructed to think about different aspects of their life, like physical health, energy, family, money, and others to assess their situation in each area. The Quality of Life questionnaire is a 13-item scale with Likert response scales ranging between 1 and 4 points. The measure's total score can range between 13 - 52 points. A higher total score is reflective of a higher quality of life while a lower score is reflective of a poorer quality of life.

Time frame
Baseline and 6 month post intervention
3

Project 2, Phase 2: Mean Difference in Score of reported depression, assessed using the Center for Epidemiological Studies-Depression (CES-D) Scale

The CES-D is a self-report depression scale for research in general population. It is a 20 item questionnaire consisting of likert response scales ranging from 0-3 points. The total score range is 0 - 60 points. Higher scores indicate participants have a greater level of self reported depression.

Time frame
Baseline and 6 month post intervention
4

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)

The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability. The 8 subscales or domains are as follows: Physical functioning (10 items); Role limitations due to physical health (4 items); Role limitations due to emotional problems (4 items); Energy/fatigue (4 items); Emotional well-being (5 items); Social functioning (2 items); Pain (2 items); General health (5 items).

Time frame
Baseline and 6 month post intervention

Other outcomes

Sponsors and contacts

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Weill Medical College of Cornell University

Lead sponsor

National Institute on Aging (NIA)

Collaborator

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