Evaluating a Digital Memory Notebook App to Improve Functional Independence

NCT ID: NCT03453554

Last Updated: 2018-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2021-08-30

Brief Summary

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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

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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

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Mild Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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DMN/Smart Home Partnership

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.

Group Type EXPERIMENTAL

Digital Notebook app

Intervention Type OTHER

Training in use of Digital Memory Notebook app

Smart Home Prompting

Intervention Type OTHER

Smart-home sensor based activity-aware prompting to support digital memory notebook app use

Digital Memory Notebook app

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.

Group Type ACTIVE_COMPARATOR

Digital Notebook app

Intervention Type OTHER

Training in use of Digital Memory Notebook app

Interventions

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Digital Notebook app

Training in use of Digital Memory Notebook app

Intervention Type OTHER

Smart Home Prompting

Smart-home sensor based activity-aware prompting to support digital memory notebook app use

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

Washington State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maureen Schmitter-Edgecombe, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington State University

Locations

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Washington State University - Pullman

Pullman, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Maureen Schmitter-Edgecombe, PhD

Role: CONTACT

5093350170

Stephanie Saltness, B.S.

Role: CONTACT

5093354033

Facility Contacts

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Maureen Schmitter-Edgecombe, PhD

Role: primary

509-335-0170

Stephanie Saltness, BA

Role: backup

5093354033

References

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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.

Reference Type DERIVED
PMID: 36939601 (View on PubMed)

Schmitter-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.

Reference Type DERIVED
PMID: 34776442 (View on PubMed)

Chudoba 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.

Reference Type DERIVED
PMID: 31046586 (View on PubMed)

Other Identifiers

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AZ150096

Identifier Type: -

Identifier Source: org_study_id

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