Evaluating a Digital Memory Notebook App to Improve Functional Independence

NCT03453554 | Unknown

• 1 other identifier: AZ150096
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Mild Cognitive Impairment

Keywords

technology; activities of daily living; everyday functioning; quality of life; memory impairment

Outcome Measures

Primary Outcomes (4)

• 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).

• 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).

• 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).

• 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 Outcomes (2)

• Coping self-efficacy

  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

  Total change in cognitive functioning as measured by RBANS (total score) at baseline and end of intervention (6 Months)

Study Arms (2)

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.

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.

Other: Digital Notebook app

Interventions

Digital Notebook app OTHER

Training in use of Digital Memory Notebook app

DMN/Smart Home Partnership; Digital Memory Notebook app

Smart Home Prompting OTHER

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

DMN/Smart Home Partnership

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• unable to provide own informed consent
• lack insight/awareness that are experiencing memory difficulties

Sponsors & Collaborators

• Washington State University: lead
• United States Department of Defense: collaborator

Study Sites (1)

Washington State University - Pullman

Pullman, Washington, 99164-4820, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 36939601 DERIVED

• 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.

  PMID: 34776442 DERIVED

• 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.

  PMID: 31046586 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Memory Disorders

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Maureen Schmitter-Edgecombe, PhD

  Washington State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maureen Schmitter-Edgecombe, PhD

CONTACT

5093350170; schmitter-e@wsu.edu

Stephanie Saltness, B.S.

CONTACT

5093354033; stephanie.salthness@wsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2018
• First Posted: March 5, 2018
• Study Start: August 1, 2018
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2021
• Last Updated: October 9, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)