Mild Cognitive Impairment
Conditions
Keywords
cognitive training, person-centered approach
Brief summary
Computerized cognitive interventions (CCIs) have been increasingly widely implemented among older adults with mild cognitive impairment (MCI). However, the efficacy of CCIs in maintaining or improving older adults' cognitive and functional health has been modest and highly variable. Older individuals' attitudes toward technology use may help explain some of the variability in CCI effects. The goal of this R21 is to generate proof-of-concept for an intervention that may improve attitudes toward computers among those with MCI, in turn improving engagement with and efficacy of a subsequent CCI. Person-centered care-that is, integrating individuals' preferences throughout the process of intervention--has improved intervention engagement among older persons, including those with MCI. A recent intervention predicated on this person-centered approach is called "personalized engagement program" (PEP). PEP involves a database of individualized computer-led leisure activities. The investigators' recent pilot data in senior living facilities suggest that PEP promotes psychological well-being among older persons with MCI, and may shift computers from dauntingly complex or personally irrelevant devices to familiar, enjoyable technology. These results are consistent with a number of theories indicating that exposure to pleasurable experiences with an object or task improves several dimensions of attitudes, including affective and cognitive components, as well as behavior and motivation. Grounded in both this pilot data and the theory around it, the investigators seek to take the next step in an arc of research ultimately intended to improve the efficacy of CCIs. A small randomized controlled trial (RCT) is proposed to assess whether an initial period of PEP, followed by a standard CCI, improves a) attitudes toward computers, b) engagement with the CCI, and c) cognitive outcomes, compared to an attention control period followed by CCI. Our design involving stratified random assignment of 50 assisted living residents with MCI from 4 senior living facilities to these two groups. The initial phase involves 4 weeks of either attention control or PEP, a "dose" suggested by prior work on attitude change and computers, followed by 6 weeks of CCI for both groups (a period our prior work indicates is sufficient for change in key cognitive domains among this population). This application is the first of which we are aware striving to augment CCIs, which are now ubiquitous, by addressing an attitudinal or affective element of the person, which are often ignored in the cognitive intervention literature. The adjuvant of PEP also answers increasing calls for "personalized" or "person-centered" behavioral interventions with older persons.
Interventions
BEHAVIORALPEP
The PEP system is built on a picture-based touch-screen interface on tablet computers. PEP allows users to explore and participate in entertainment, educational, spiritual, and other recreational activities and content personalized according to their interests and preferences. It provides easy access to the Internet and communication applications, and has hundreds of modules spanning music, travel, trivia, games, and religious and inspirational domains. For instance, if music is among a person's lifelong interests, the system provides access to multiple music genres through jukebox, karaoke and therapeutic music applications that can be tailored to a particular activity and by individual interest (for instance, a preference for classic jazz). As another example, for someone who likes travel or visiting new places, the interface offers access to Google Earth, guided tours, slide shows and regional facts and history.
BEHAVIORALCCI
VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention. All exercises share visual components and focus on accuracy and fast reaction times. Participants respond either by identifying what object they see or where they see it on the screen. The training will automatically adjust the difficulty of each task based on the participant's performance, ensuring that the participants always operate near their optimal capacity. The training programs will automatically record the percentage of completion of each game and scores.
Sponsors
University of Rochester
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessor will be blinded to the group assignment. The participants will be informed to avoid discussing their intervention activities at the post-training and follow up assessments.
Intervention model description
A single-blinded, multi-site (4 SLCs) randomized controlled trial of PEP+CCI, vs. control + CCI is involved. For PEP+CCI group, PEP will be implemented for the first 4 weeks, and CCI for the following 6 weeks. For the control + CCI group, an inert control condition, consisting of nothing outside of the ordinary, will be implemented for the first 4 weeks, and CCI for 6 more weeks. Assessments will be conducted by our research team. Separate staff blind to group assignment will conduct post-training and follow-up assessments. All intervention and assessments will occur in private rooms in relevant SLCs.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 ≤ MoCA ≤ 26 * RAVLT Delayed Recall Total Score ≤ 6 (or 1.5 SD below age-corrected norms) * mild or no active depressive symptoms * intact or mild deficits in IADL functioning * if on AD medication (i.e., Memantine or cholinesterase inhibitors), antidepressant, or anxiolytics, no changes of doses in the 3 months prior to recruitment; * age ≥60 years * English-speaking * adequate visual and hearing acuity for testing * intact decision making capacity.
Exclusion criteria
* current enrollment in another cognitive improvement study; * uncontrollable major depression: or other psychopathology identified by staff or medical records; * having active legal guardian (indicating impaired capacity for decision making); * medical history of AD or other types of dementia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in ADL Score From Baseline to Week 10 | Baseline to Week 10 | The Activities of Daily Living (ADL) score is the sum of 15 items, resulting in a total performance score ranging from 0 to 60. Lower scores indicate better self-perceived functioning in daily living activities, while higher scores indicate more impaired functioning. The change score was calculated as Week 10 minus Baseline. |
| Mean Change in ADL Score From Baseline to Week 23 | Baseline to Week 23 | The Activities of Daily Living (ADL) score is the sum of 15 items, creating a total score ranging from 0 to 60. Lower scores indicate better self-perceived functioning in daily living activities, while higher scores indicate more impaired functioning. The change score was calculated as Week 23 minus Baseline. |
| Mean Executive Function Measured by Examiner | Baseline to week 4 | EXAMINER provides a scoring script that generates an Executive Function (EF) composite by applying item response theory (IRT) Empirical Bayes scoring to the raw continuous task scores. The composite is presented in the original metric used in the item response theory algorithm; the score is not a norm-referenced measure and is not adjusted for age. EF was measured with a subset of five tasks (flanker, set-shifting, dot-counting, category fluency, 1-back and anti-saccades) from the NIH EXAMINER v3.6 battery (Kramer et al., 2014). The composite is presented in the original metric used in the item response theory algorithm; the score is not a norm-referenced measure and is not adjusted for age. Scores range from -1.50 to 1.52. Higher scores mean better executive function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Attitudes Toward Computers Questionnaire | Baseline to week 4 | The Attitudes Toward Computers Questionnaire (ATCQ) is a 35-item self-report scale using 5-point Likert responses (1 = strongly disagree to 5 = strongly agree), assessing comfort, efficacy, gender equality, control, interest, dehumanization, and utility. A composite mean score is calculated. Minimum score: 1; Maximum score: 5, Higher scores indicate more positive attitudes toward computers. |
| Mean Change in Brief Visuospatial Memory Test | Baseline to Week 4 | The Brief Visuospatial Memory Test-Revised (BVMT-R) delayed recall raw score measures the number of stimuli correctly recalled after a delay. Scores range from 0 to 12, with higher scores indicating better memory performance. Change scores were calculated as Week 4 minus Baseline. |
| Mean Change in EPCCE Sum Score From Baseline to Week 4 | Baseline to Week 4 | The Executive Problem-Solving and Cognitive Efficiency (EPCCE) sum score ranges from 0 to 14, with higher scores indicating greater independence and problem-solving ability. Change scores were calculated as Week 4 minus Baseline. |
| Mean Change in EPCCE Sum Score From Baseline to Week 10 | Baseline to Week 10 | The Executive Problem-Solving and Cognitive Efficiency (EPCCE) sum score ranges from 0 to 14, with higher scores indicating greater independence and problem-solving ability. Change scores were calculated as Week 10 minus Baseline. |
| Mean Change in EPCCE Sum Score From Baseline to Week 23 | Baseline to Week 23 | The Executive Problem-Solving and Cognitive Efficiency (EPCCE) sum score ranges from 0 to 14, with higher scores indicating greater independence and problem-solving ability. Change scores were calculated as Week 23 minus Baseline. |
| Mean Change in UFOV Score From Baseline to Week 10 | Baseline to Week 10 | The UFOV score is the mean of three subtests: processing speed, divided attention, and selective attention. Each subtest ranges from 17 to 500 milliseconds. Lower scores indicate faster visual processing and better cognitive performance. Change scores were calculated as Week 10 minus Baseline. |
| Mean Change in UFOV Score From Baseline to Week 23 | Baseline to Week 23 | The UFOV score is the mean of three subtests: processing speed, divided attention, and selective attention. Each subtest ranges from 17 to 500 milliseconds. Lower scores indicate faster visual processing and better cognitive performance. Change scores were calculated as Week 23 minus Baseline. |
| Mean Change in Activities of Daily Living-Prevention Instrument | Baseline to week 23 | Mean change in self-perceived functioning in daily living activities as measured by the Activities of Daily Living - Prevention Instrument (ADL-PI). The ADL-PI is a sum score of 15 items, with a total score range of 0-60. Higher scores indicate more impaired functioning, while lower scores indicate better functioning. |
Countries
United States
Contacts
STUDY_DIRECTORAnne Corriveau, PhD
University of Rochester
Participant flow
Pre-assignment details
83 people were accessed to eligibility; 3 were not interested and 31 did not meet inclusion criteria.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 86.39 years STANDARD_DEVIATION 5.66 |
| Race/Ethnicity, Customized Non-hispanic Asian | 0 Participants |
| Race/Ethnicity, Customized Non-hispanic Black | 2 Participants |
| Race/Ethnicity, Customized Non-hispanic More than One Race | 1 Participants |
| Race/Ethnicity, Customized Non-hispanic, white | 22 Participants |
| Region of Enrollment United States | 49 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 1 / 25 |
| other Total, other adverse events | 0 / 24 | 0 / 25 |
| serious Total, serious adverse events | 0 / 24 | 0 / 25 |
Outcome results
None listed