Evaluating a Digital Memory Notebook App to Improve Functional Independence

• ClinicalTrials.gov Identifier: NCT03453554
• Recruitment Status: Unknown
• First Posted: March 5, 2018
• Last Update Posted: October 9, 2018
• Sponsor: Washington State University
• Collaborator: United States Department of Defense
• Information provided by (Responsible Party): Washington State University

Tracking Information

• First Submitted Date: February 7, 2018
• First Posted Date: March 5, 2018
• Last Update Posted Date: October 9, 2018
• Actual Study Start Date: August 1, 2018
• Estimated Primary Completion Date: August 30, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 26, 2018)

• 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 26, 2018)

• 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) ]
  The Coping Self Efficacy Scale (CSES) assesses participants' perceived abilities to cope with life challenges.
• Cognitive functioning [ Time Frame: Total change in cognitive functioning as measured by RBANS (total score) at baseline and end of intervention (6 Months) ]
  Neuropsychological assessment: Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluating a Digital Memory Notebook App to Improve Functional Independence
• Official Title: Evaluating a Digital Memory Notebook Intervention to Improve Independence and Quality of Life

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.

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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Supportive Care
• Condition: Mild Cognitive Impairment

Intervention

• Other: Digital Notebook app
  Training in use of Digital Memory Notebook app
• Other: Smart Home Prompting
  Smart-home sensor based activity-aware prompting to support digital memory notebook app use

Study Arms

• Experimental: 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.
  Interventions:

  • Other: Digital Notebook app
  • Other: Smart Home Prompting
• Active Comparator: 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.
  Intervention: Other: Digital Notebook app

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: February 26, 2018): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 30, 2021
• Estimated Primary Completion Date: August 30, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03453554
• Other Study ID Numbers: AZ150096
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Washington State University
• Original Responsible Party: Same as current
• Current Study Sponsor: Washington State University
• Original Study Sponsor: Same as current
• Collaborators: United States Department of Defense

Investigators

• Principal Investigator: Maureen Schmitter-Edgecombe, PhD; Washington State University

• PRS Account: Washington State University
• Verification Date: February 2018