- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04206670
In-Home Technology for Caregivers of People With Dementia and Mild Cognitive Impairment
Developing and Evaluating In-Home Supportive Technology for Caregivers of People With Dementia and Mild Cognitive Impairment
Study Overview
Status
Conditions
Detailed Description
This study aims to develop, refine, and evaluate a new hardware/software system designed to integrate in-home sensors and devices, Internet-of-Things technologies (i.e., devices that can be controlled and communicated with via the internet), and social networking to create a more safe and supportive home environment for caregivers and people who have Alzheimer's disease, other dementias, or mild cognitive impairment. The system monitors troublesome behaviors in people with dementia or mild cognitive impairment (e.g., wandering), and targets mechanisms (e.g., worry, social isolation) thought to link behavioral symptoms in people with dementia or mild cognitive impairment with adverse caregiver outcomes (declines in health and well-being). The system is designed to minimize demands on caregivers' limited time and energy and to provide a platform for data collection that can be used by researchers and care professionals.
Hypotheses:
- Caregivers in the full operation condition will have fewer negative effects of caregiving (lower burden, better mental and physical health, higher well-being) than those in the control condition.
- Greater use of the social networking features of the system will be associated with fewer caregiver depressive symptoms.
- Greater utilization of the home safety features of the system will be associated with fewer caregiver anxiety symptoms.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Berkeley, California, United States, 94720
- University of California, Berkeley
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Caregivers are fluent/literate in English
- Caregivers currently reside with spouse/family member who has received a diagnosis of Alzheimer's disease, other dementias, or mild cognitive impairment
- Caregivers primarily use a smartphone (e.g., iPhone, Android)
- Caregiver has wireless internet in home
Exclusion Criteria:
- Caregivers providing care for individuals with known non-neurodegenerative conditions affecting behavior and cognition
- Caregivers providing care for individuals with longstanding Axis I psychiatric disorder
- Caregivers providing care for individuals with metabolic disorder or major organ dysfunction
- Caregivers providing care for individuals with alcohol abuse or dependence (within 5 years of dementia onset)
- Caregivers providing care for individuals with head trauma with loss of consciousness greater than 30 minutes
- Caregivers providing care for individuals with contraindications to MRI imaging
- Caregivers providing care for individuals with large confluent white matter lesions
- Caregivers providing care for individuals with significant systemic medical illness
- Caregivers providing care for individuals who use a medication likely to affect central nervous system functions adversely
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: In-Home Technology System
Participants will receive and install the full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) in their homes.
Remote assistance will be provided to help with the installation.
Sensors, warnings, messaging, and social networking features will be activated remotely.
Participation will extend over a six month period with questionnaires (e.g., health and well-being) administered 3 times (at the time of installation and every 3 months thereafter).
|
Participants self-install the in-home technology system in their homes after enrollment in the study (i.e., consent procedures and initial questionnaire).
Intelligent bots monitor the in-home sensors, learn typical patterns, and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome behaviors occur.
Social contact is encouraged using caregiver resources and a trusted circle of friends and family who are encouraged to stay in contact with the caregiver and person with dementia or mild cognitive impairment.
|
Other: Waiting Control
Participants will be assigned a date for receiving and installing the full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) six months after they enter the study.
During that six-month period, questionnaires (e.g., health and well-being) will be administered 3 times (at the start of the study and every 3 months thereafter).
At the end of the six-month period, participants will receive and install the full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) in their homes.
Remote assistance will be provided to help with the installation.
Sensors, warnings, messaging, and social networking features will be activated remotely.
Participation will extend over an additional six-month period with questionnaires (e.g., health and well-being) administered 2 times (every 3 months following installation).
|
Participants self-install the in-home technology system in their homes six months after their enrollment in the study (i.e., consent procedures and initial questionnaire).
Intelligent bots monitor the in-home sensors, learn typical patterns, and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome behaviors occur.
Social contact is encouraged using caregiver resources and a trusted circle of friends and family who are encouraged to stay in contact with the caregiver and person with dementia or mild cognitive impairment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
3 Months Assessment for Center for Epidemiological Studies Depression Scale (CES-D)
Time Frame: 3 months after baseline
|
Questionnaire to measure depression (Radloff, 1977).
20 items are rated on a 0-3 scale and summed (range = 0-60).
There are no subscales.
Higher scores represent worse outcomes.
The clinical cut-off is usually set at a score of 16.
|
3 months after baseline
|
6 Months Assessment for Center for Epidemiological Studies Depression Scale (CES-D)
Time Frame: 6 months after baseline
|
Questionnaire to measure depression (Radloff, 1977).
20 items are rated on a 0-3 scale and summed (range = 0-60).
There are no subscales.
Higher scores represent worse outcomes.
The clinical cut-off is usually set at a score of 16.
|
6 months after baseline
|
3 Months Assessment for Zarit Burden Interview-Short Form
Time Frame: 3 months after baseline
|
Questionnaire to measure caregiver burden (Zarit, Reever, & Bach-Peterson, 1980).
12 items are rated on 0-4 scale.
Range: 0-48.
No subscales.
Higher scores represent worse outcomes.
|
3 months after baseline
|
6 Months Assessment for Zarit Burden Interview-Short Form
Time Frame: 6 months after baseline
|
Questionnaire to measure caregiver burden (Zarit, Reever, & Bach-Peterson, 1980).
12 items are rated on 0-4 scale.
Range: 0-48.
No subscales.
Higher scores represent worse outcomes.
|
6 months after baseline
|
3 Months Assessment for Beck Anxiety Inventory (BAI)
Time Frame: 3 months after baseline
|
Questionnaire to measure anxiety (Beck, Epstein, Brown, & Steer, 1988).
20 items are rated on a 0-3 scale and summed (range= 0-60).
Higher scores indicate worse outcomes.
There are no subscales.
A score greater than 36 is considered to be clinically significant.
|
3 months after baseline
|
6 Months Assessment for Beck Anxiety Inventory (BAI)
Time Frame: 6 months after baseline
|
Questionnaire to measure anxiety (Beck, Epstein, Brown, & Steer, 1988).
20 items are rated on a 0-3 scale and summed (range= 0-60).
Higher scores indicate worse outcomes.
There are no subscales.
A score greater than 36 is considered to be clinically significant.
|
6 months after baseline
|
3 Months Assessment for Satisfaction With Life Scale
Time Frame: 3 months after baseline
|
Questionnaire measuring overall life satisfaction and well-being (Diener, Emmons, Larsen, & Griffin, 1985).
5 items scored on a 1-7 scale and summed (Range = 5-35).
Lower scores indicate worse outcomes.
A score of 20 is considered neutral with higher scores considered increasingly more satisfied and lower scores considered increasingly more dissatisfied.
|
3 months after baseline
|
6 Months Assessment for Satisfaction With Life Scale
Time Frame: 6 months after baseline
|
Questionnaire measuring overall life satisfaction and well-being (Diener, Emmons, Larsen, & Griffin, 1985).
5 items scored on a 1-7 scale and summed (Range = 5-35).
Lower scores indicate worse outcomes.
A score of 20 is considered neutral with higher scores considered increasingly more satisfied and lower scores considered increasingly more dissatisfied.
|
6 months after baseline
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Robert W Levenson, Ph.D., University of California, Berkeley
Publications and helpful links
General Publications
- Chen KH, Wells JL, Otero MC, Lwi SJ, Haase CM, Levenson RW. Greater Experience of Negative Non-Target Emotions by Patients with Neurodegenerative Diseases Is Related to Lower Emotional Well-Being in Caregivers. Dement Geriatr Cogn Disord. 2017;44(5-6):245-255. doi: 10.1159/000481132. Epub 2017 Dec 8.
- Lwi SJ, Ford BQ, Casey JJ, Miller BL, Levenson RW. Poor caregiver mental health predicts mortality of patients with neurodegenerative disease. Proc Natl Acad Sci U S A. 2017 Jul 11;114(28):7319-7324. doi: 10.1073/pnas.1701597114. Epub 2017 Jun 27.
- Otero MC, Levenson RW. Lower Visual Avoidance in Dementia Patients Is Associated with Greater Psychological Distress in Caregivers. Dement Geriatr Cogn Disord. 2017;43(5-6):247-258. doi: 10.1159/000468146. Epub 2017 Apr 11.
- Brown CL, Lwi SJ, Goodkind MS, Rankin KP, Merrilees J, Miller BL, Levenson RW. Empathic Accuracy Deficits in Patients with Neurodegenerative Disease: Association with Caregiver Depression. Am J Geriatr Psychiatry. 2018 Apr;26(4):484-493. doi: 10.1016/j.jagp.2017.10.012. Epub 2017 Dec 27.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R44AG059458-03 (U.S. NIH Grant/Contract)
- R44AG059458 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dementia
-
University of North Carolina, Chapel HillNational Institute on Aging (NIA)CompletedAlzheimer Dementia | Dementia Alzheimers | CaregiverUnited States
-
Temple UniversityRecruitingDementia | Mild Cognitive Impairment | Dementia, Vascular | Dementia, Mixed | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Dementia, MildUnited States
-
Hebrew SeniorLifeRecruitingAging | Alzheimer Dementia | Presenile Alzheimer DementiaUnited States
-
Temple UniversityRecruitingDementia | Alzheimer Disease | Mild Cognitive Impairment | Dementia, Vascular | Dementia, Mixed | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Dementia, MildUnited States
-
National Tainan Junior College of NursingCompletedCognitive Impairment | Dementia, Mild | Dementia ModerateTaiwan
-
Cognito Therapeutics, Inc.Enrolling by invitationExtension to a Pivotal Study of Sensory Stimulation in Alzheimer's Disease (OLE Hope Study, CA-0015)Cognitive Impairment | Alzheimer Disease | Mild Cognitive Impairment | Dementia Alzheimers | Dementia of Alzheimer Type | AD | Dementia, Mild | Dementia ModerateUnited States
-
Karen RobertoNational Institute on Aging (NIA)RecruitingDementia | Dementia Alzheimers | Neuro-Degenerative Disease | Dementia of Alzheimer Type | Dementia SevereUnited States
-
University College, LondonNot yet recruitingDementia | Dementia, Vascular | Dementia, Mixed | Dementia With Lewy Bodies | Dementia of Alzheimer Type | Dementia Moderate | Dementia Severe | Dementia Frontal | DEM
-
University College, LondonThe University of Hong KongUnknownDementia | Dementia, Vascular | Dementia, Mixed | Dementia With Lewy Bodies | Dementia of Alzheimer Type | Dementia Moderate | Dementia Severe | Dementia Frontal
-
Karolinska InstitutetRegion Stockholm; KTH Royal Institute of TechnologyActive, not recruitingAlzheimer Dementia | Dementia DisordersSweden
Clinical Trials on In-Home Technology System and Questionnaires
-
University of California, BerkeleyNational Institute on Aging (NIA); University of California, San Francisco; People...RecruitingDementia | Alzheimer Disease | Mild Cognitive ImpairmentUnited States
-
University of California, BerkeleyNational Institute on Aging (NIA); University of California, San Francisco; People...RecruitingIn-Home Technology for Caregivers of People With Dementia and Mild Cognitive Impairment: Rural HomesDementia | Alzheimer Disease | Mild Cognitive ImpairmentUnited States
-
University of California, BerkeleyNational Institute on Aging (NIA); University of California, San Francisco; People...CompletedDementia | Alzheimer Disease | Mild Cognitive ImpairmentUnited States
-
University of California, BerkeleyNational Institute on Aging (NIA); University of California, San Francisco; People...CompletedDementia | Frontotemporal Dementia | Alzheimer's DiseaseUnited States
-
Biotronik Japan, Inc.Completed
-
Istituto Auxologico ItalianoRecruitingAnorexia Nervosa | Parkinson DiseaseItaly
-
Federico II UniversityCompleted
-
Marmara UniversityCompletedQuality of Life | Pain | Balance; Distorted | Aging ProblemsTurkey
-
University of UtahInternational Institute for Restorative Reproductive MedicineCompletedInfertility | MiscarriageUnited States, Canada, Poland, United Kingdom
-
University of MichiganMichigan Department of Health and Human ServicesRecruitingSurgery | Analgesics, OpioidsUnited States