Mild Cognitive ImpairmentNCT03453554
Evaluating a Digital Memory Notebook App to Improve Functional Independence
A study testing Digital Notebook app and Smart Home Prompting in people with Mild Cognitive Impairment, run by Washington State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Digital Notebook app and Smart Home Prompting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 30 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- unable to provide own informed consent
- lack insight/awareness that are experiencing memory difficulties
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Washington State University - Pullman
Pullman, Washington, 99164-4820
Maureen Schmitter-Edgecombe, PhD, 509-335-0170, schmitter-e@wsu.edu
Stephanie Saltness, BA, 5093354033, stephanie.saltness@wsu.edu
About this study
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.
Read the detailed description
Approximately 30 older adults who complain of memory problems will be recruited for this study. Over the course of six months, participants will complete questionnaires, open-ended questions, and cognitive and motor screens. Participants will also undergo training to learn to use a DMN to support daily activities and will continue to use the DMN for three months following training. Additionally, half of the participants' homes will be equipped with our "smart home in a box" technology that will support DMN use with context-aware prompting technology.
During month one, participants in both conditions will complete a cognitive and motor screen as well as questionnaires assessing depression, quality of life, coping, everyday memory, and functional abilities. Care-partners/informants (when available) will also complete the same questionnaires as well as an additional questionnaire about caregiver burden. The questionnaires will be administered monthly (6x total) for the duration of the study.
During month two, graduate students will train study participants to use the DMN using a training manual and workbook in 6-8 training sessions (depending on participants comfort with the DMN) over 3-4 weeks. Supervision will include review of audiotapes and use of a checklist to monitor fidelity of the training content and process. Participants and care-partners will also answer open-ended questions designed to help improve the DMN and its training procedure as well as the prompting technology and its integration with the DMN at each assessment period. In addition, participants and care-partners will complete questionnaires about their satisfaction and perception of ease of use of the DMN and interface as well as a questionnaire concerning likeability and cognitive demand.
During months three through five, data collection will continue. Participants in the smart home condition will use the DMN in conjunction with prompting technology for the third month, only the DMN for the fourth month, and again the DMN and prompting technology for the fifth month. Control participants will use only the DMN for all three months. Control participants will rely on traditional methods (e.g., time-based alarm cues, sticky notes) to support DMN use rather than activity-aware prompting technology.
During month six, participants will complete a post-test cognitive and motor screen identical to the initial screen. Participants will also complete the set of the previously described questionnaires and open-ended questions.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Digital Notebook app, Smart Home Prompting
- Keywords
- technology, activities of daily living, everyday functioning, quality of life, memory impairment
- Medical subject headings
- Cognitive Dysfunction, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Notebook appOther
Training in use of Digital Memory Notebook app
Smart Home PromptingOther
Smart-home sensor based activity-aware prompting to support digital memory notebook app use
| Study group | Role | What they receive |
|---|---|---|
| DMN/Smart Home Partnership | Experimental | Participants will learn how to use a digital memory notebook partnered with smart environment prompting technology to support everyday activities of daily living and reduce problems associated with memory deficits. Receives: Other: Digital Notebook app; Other: Smart Home Prompting |
| Digital Memory Notebook app | Active comparator | Participants will learn how to use a Digital Memory Notebook app to support everyday activities of daily living and reduce problems associated with memory deficits. Receives: Other: Digital Notebook app |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change will be assessed between monthly time points (1-, 2-, 3-, 4-, and 5-months).
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.
Measured: 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).
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.
Measured: 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).
Caregiver Burden
The Caregiver Burden Scale (CBS; Elmstahl et al., 1996) will be used to assess caregiver burden experienced by participants' care-partners.
Measured: 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 outcomes (2)
Coping self-efficacy
The Coping Self Efficacy Scale (CSES) assesses participants' perceived abilities to cope with life challenges.
Measured: 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)
Cognitive functioning
Neuropsychological assessment: Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Measured: Total change in cognitive functioning as measured by RBANS (total score) at baseline and end of intervention (6 Months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start1 Aug 2018
- Primary completion30 Aug 2021 (estimated)
- Study completion30 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington State University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Maureen Schmitter-Edgecombe, PhD, Principal investigator, Washington State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03453554
- Sponsor's protocol ID
- AZ150096
- Status last verified
- Feb 2018
- First submitted
- 7 Feb 2018
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Luna C, Cook DJ, Schmitter-Edgecombe M. But will they use it? Predictors of adoption of an electronic memory aid in individuals with amnestic mild cognitive impairment. Neuropsychology. 2023 Nov;37(8):955-965. doi: 10.1037/neu0000898. Epub 2023 Mar 20.
PubMed 36939601Schmitter-Edgecombe M, Brown K, Luna C, Chilton R, Sumida CA, Holder L, Cook D. Partnering a Compensatory Application with Activity-Aware Prompting to Improve Use in Individuals with Amnestic Mild Cognitive Impairment: A Randomized Controlled Pilot Clinical Trial. J Alzheimers Dis. 2022;85(1):73-90. doi: 10.3233/JAD-215022.
PubMed 34776442Chudoba LA, Church AS, Dahmen JB, Brown KD, Schmitter-Edgecombe M. The development of a manual-based digital memory notebook intervention with case study illustrations. Neuropsychol Rehabil. 2020 Oct;30(9):1829-1851. doi: 10.1080/09602011.2019.1611606. Epub 2019 May 3.
PubMed 31046586
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Digital Memory Notebook Intervention to Improve Independence and Quality of Life
- ClinicalTrials.gov ID
- NCT03453554
- Acronym / sponsor ID
- AZ150096
- Conditions
- Mild Cognitive Impairment
- Keywords
- technology, activities of daily living, everyday functioning, quality of life, memory impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Washington State UniversityUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 30 Aug 2021 (estimated)
- Study completion
- 30 Aug 2021 (estimated)
- First posted
- 5 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Approximately 30 older adults who complain of memory problems will be recruited for this study. Over the course of six months, participants will complete questionnaires, open-ended questions, and cognitive and motor screens. Participants will also undergo training to learn to use a DMN to support daily activities and will continue to use the DMN for three months following training. Additionally, half of the participants' homes will be equipped with our "smart home in a box" technology that will support DMN use with context-aware prompting technology.
During month one, participants in both conditions will complete a cognitive and motor screen as well as questionnaires assessing depression, quality of life, coping, everyday memory, and functional abilities. Care-partners/informants (when available) will also complete the same questionnaires as well as an additional questionnaire about caregiver burden. The questionnaires will be administered monthly (6x total) for the duration of the study.
During month two, graduate students will train study participants to use the DMN using a training manual and workbook in 6-8 training sessions (depending on participants comfort with the DMN) over 3-4 weeks. Supervision will include review of audiotapes and use of a checklist to monitor fidelity of the training content and process. Participants and care-partners will also answer open-ended questions designed to help improve the DMN and its training procedure as well as the prompting technology and its integration with the DMN at each assessment period. In addition, participants and care-partners will complete questionnaires about their satisfaction and perception of ease of use of the DMN and interface as well as a questionnaire concerning likeability and cognitive demand.
During months three through five, data collection will continue. Participants in the smart home condition will use the DMN in conjunction with prompting technology for the third month, only the DMN for the fourth month, and again the DMN and prompting technology for the fifth month. Control participants will use only the DMN for all three months. Control participants will rely on traditional methods (e.g., time-based alarm cues, sticky notes) to support DMN use rather than activity-aware prompting technology.
During month six, participants will complete a post-test cognitive and motor screen identical to the initial screen. Participants will also complete the set of the previously described questionnaires and open-ended questions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DMN/Smart Home Partnership | Experimental | Other: Digital Notebook app, Other: Smart Home PromptingParticipants will learn how to use a digital memory notebook partnered with smart environment prompting technology to support everyday activities of daily living and reduce problems associated with memory deficits. |
| Digital Memory Notebook app | Active comparator | Other: Digital Notebook appParticipants will learn how to use a Digital Memory Notebook app to support everyday activities of daily living and reduce problems associated with memory deficits. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- unable to provide own informed consent
- lack insight/awareness that are experiencing memory difficulties
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Notebook appTraining in use of Digital Memory Notebook app | Other | DMN/Smart Home Partnership, Digital Memory Notebook app |
| Smart Home PromptingSmart-home sensor based activity-aware prompting to support digital memory notebook app use | Other | DMN/Smart Home Partnership |
Primary outcome
Digital Memory Notebook Use
Time frame: Change will be assessed between monthly time points (1-, 2-, 3-, 4-, and 5-months).
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.
Quality of Life
Time frame: 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).
The Quality of Life-Alzheimer's disease (QOL-AD; Logsdon, 1996) scale will be used to measure quality of life and subjective well-being.
Activities of Daily Living
Time frame: 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).
The Instrumental Activities of Daily Living- Compensation (IADL-C; Schmitter-Edgecombe, Parsey, \& Lamb, 2014) will be used to provide an estimate of functional difficulties.
Caregiver Burden
Time frame: 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).
The Caregiver Burden Scale (CBS; Elmstahl et al., 1996) will be used to assess caregiver burden experienced by participants' care-partners.
2 secondary outcomes
Coping self-efficacy
Time frame: 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)
Cognitive functioning
Time frame: Total change in cognitive functioning as measured by RBANS (total score) at baseline and end of intervention (6 Months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Derived from this study: PubMed 36939601Luna C, Cook DJ, Schmitter-Edgecombe M. But will they use it? Predictors of adoption of an electronic memory aid in individuals with amnestic mild cognitive impairment. Neuropsychology. 2023 Nov;37(8):955-965. doi: 10.1037/neu0000898. Epub 2023 Mar 20.
- Derived from this study: PubMed 34776442Schmitter-Edgecombe M, Brown K, Luna C, Chilton R, Sumida CA, Holder L, Cook D. Partnering a Compensatory Application with Activity-Aware Prompting to Improve Use in Individuals with Amnestic Mild Cognitive Impairment: A Randomized Controlled Pilot Clinical Trial. J Alzheimers Dis. 2022;85(1):73-90. doi: 10.3233/JAD-215022.
- Derived from this study: PubMed 31046586Chudoba LA, Church AS, Dahmen JB, Brown KD, Schmitter-Edgecombe M. The development of a manual-based digital memory notebook intervention with case study illustrations. Neuropsychol Rehabil. 2020 Oct;30(9):1829-1851. doi: 10.1080/09602011.2019.1611606. Epub 2019 May 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maureen Schmitter-Edgecombe, PhD principal investigator
Washington State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Notebook app and Smart Home Prompting in people with Mild Cognitive Impairment, run by Washington State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maureen Schmitter-Edgecombe, PhD (5093350170, schmitter-e@wsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Digital Memory Notebook Use (time frame: Change will be assessed between monthly time points (1-, 2-, 3-, 4-, and 5-months).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03453554, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2018.