Mild Cognitive Impairment Clinical Trial
Official title:
Evaluating a Digital Memory Notebook Intervention to Improve Independence and Quality of Life
This study will investigate the efficacy of a smart home / digital memory notebook (DMN)
partnership that will allow for real-time intervention and thereby facilitate acquisition and
use of the DMN to support everyday independence. The DMN is an app that is installed on a
mobile tablet. The smart home technology discovers and recognizes generalizable activities
and provides information about functional status and health-related variables for older adult
participants. This study will examine how smart home prompts affect individuals' DMN use,
ability to maintain activity routines, and overall wellbeing. Prompts will center on helping
users organize and schedule daily activities, record both routine and uncommon events that
may need to be remembered, and record activities performed and important associated event
information (e.g., when, what, where). Prompting will help to promote everyday functional
independence by encouraging frequent and regular notebook use and reducing memory
difficulties. The DMN will also help to support functional independence by notifying
individuals about appointments or prompting individuals to initiate important activities of
daily living (e.g., take medications).
This study will also involve a machine learning technique to gain a better understanding of
the contexts in which individuals adhere or do not adhere to the prompts. This activity-aware
intervention will be deployed in the homes of older adults with memory difficulties, to
assess the usability of the technology as well as to evaluate in a naturalistic setting the
efficacy of the technology for increasing everyday functional independence and quality of
life and decreasing care-partner burden. This contribution is significant because it will
demonstrate that intelligent technologies can improve the efficacy of traditional memory
rehabilitation techniques, extend functional independence, reduce caregiver burden, and
improve quality of life.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | August 30, 2021 |
Est. primary completion date | August 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility |
Inclusion Criteria: - age 40+ - memory problems documented by self-report - memory problems documented by cognitive data (i.e., memory testing > 1 std below expectations for age and education) - English speaking Exclusion Criteria: - unable to provide own informed consent - lack insight/awareness that are experiencing memory difficulties |
Country | Name | City | State |
---|---|---|---|
United States | Washington State University - Pullman | Pullman | Washington |
Lead Sponsor | Collaborator |
---|---|
Washington State University | United States Department of Defense |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Digital Memory Notebook Use | Mean number of monthly DMN entries made and mean number of monthly DMN uses as measured continuously via the DMN app will be totaled to form a monthly DMN Memory Notebook use score. | Change will be assessed between monthly time points (1-, 2-, 3-, 4-, and 5-months). | |
Primary | Quality of Life | The Quality of Life-Alzheimer's disease (QOL-AD; Logsdon, 1996) scale will be used to measure quality of life and subjective well-being. | Total change in quality of life as measured by QOL-AD (range 13 [poor]-52 [best]) between baseline and monthly time points (1-, 2-, 3-, 4-, and 5-months). | |
Primary | Activities of Daily Living | The Instrumental Activities of Daily Living- Compensation (IADL-C; Schmitter-Edgecombe, Parsey, & Lamb, 2014) will be used to provide an estimate of functional difficulties. | Total change in functional status as measured by IADL-C (range 27 [best]-216 [poor]) between baseline and monthly time points (1-, 2-, 3-, 4-, and 5-months). | |
Primary | Caregiver Burden | The Caregiver Burden Scale (CBS; Elmstahl et al., 1996) will be used to assess caregiver burden experienced by participants' care-partners. | Total change in caregiver burden as measured by CBS (range 0 [best]-96 [poor]) between baseline and monthly time points (1-, 2-, 3-, 4-, and 5-months). | |
Secondary | Coping self-efficacy | The Coping Self Efficacy Scale (CSES) assesses participants' perceived abilities to cope with life challenges. | Total change in coping self-efficacy as measured by CSES (range 0 [poor]-130 [best]) between baseline and monthly time points (1-, 2-, 3-, 4-, and 5-months) | |
Secondary | Cognitive functioning | Neuropsychological assessment: Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) | Total change in cognitive functioning as measured by RBANS (total score) at baseline and end of intervention (6 Months) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04513106 -
Promoting Advance Care Planning for Persons With Early-stage Dementia in the Community: a Feasibility Trial
|
N/A | |
Recruiting |
NCT06011681 -
The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
|
||
Recruiting |
NCT04522739 -
Spironolactone Safety in African Americans With Mild Cognitive Impairment and Early Alzheimer's Disease
|
Phase 4 | |
Active, not recruiting |
NCT03167840 -
Falls Prevention Through Physical And Cognitive Training in Mild Cognitive Impairment
|
N/A | |
Active, not recruiting |
NCT03676881 -
Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
|
||
Not yet recruiting |
NCT05041790 -
A Clinical Trial to Evaluate the Efficacy and Safety of Choline Alfoscerate Compared to Placebo in Patients With Degenerative Mild Cognitive Impairment
|
Phase 4 | |
Recruiting |
NCT04121156 -
High Definition Transcranial Direct Current Stimulation (HD-tDCS) in Patients With Mild Cognitive Impairment
|
N/A | |
Recruiting |
NCT03605381 -
MORbidity PRevalence Estimate In StrokE
|
||
Completed |
NCT02774083 -
Cognitive Training Using Feuerstein Instrumental Enrichment
|
N/A | |
Completed |
NCT01315639 -
New Biomarker for Alzheimer's Disease Diagnostic
|
N/A | |
Enrolling by invitation |
NCT06023446 -
Can (Optical Coherence Tomography) Pictures of the Retina Detect Alzheimer's Disease at Its Earliest Stages?
|
||
Completed |
NCT04567745 -
Automated Retinal Image Analysis System (EyeQuant) for Computation of Vascular Biomarkers
|
Phase 1 | |
Recruiting |
NCT05579236 -
Cortical Disarray Measurement in Mild Cognitive Impairment and Alzheimer's Disease
|
||
Completed |
NCT03583879 -
Using Gait Robotics to Improve Symptoms of Parkinson's Disease
|
N/A | |
Terminated |
NCT02503501 -
Intranasal Glulisine in Amnestic Mild Cognitive Impairment and Probable Mild Alzheimer's Disease
|
Phase 2 | |
Not yet recruiting |
NCT03740178 -
Multiple Dose Trial of MK-4334 in Participants With Alzheimer's Clinical Syndrome (MK-4334-005)
|
Phase 1 | |
Active, not recruiting |
NCT05204940 -
Longitudinal Observational Biomarker Study
|
||
Recruiting |
NCT02663531 -
Retinal Neuro-vascular Coupling in Patients With Neurodegenerative Disease
|
N/A | |
Recruiting |
NCT06150352 -
Sleep Apnea, Neurocognitive Decline and Brain Imaging in Patients With Subjective or Mild Cognitive Impairment
|
||
Recruiting |
NCT03507192 -
Effects of Muscle Relaxation on Cognitive Function in Patients With Mild Cognitive Impairment and Early Stage Dementia.
|
N/A |