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Evaluating a Digital Memory Notebook App to Improve Functional Independence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03453554
Recruitment Status : Unknown
Verified February 2018 by Washington State University.
Recruitment status was:  Recruiting
First Posted : March 5, 2018
Last Update Posted : October 9, 2018
United States Department of Defense
Information provided by (Responsible Party):
Washington State University

Tracking Information
First Submitted Date  ICMJE February 7, 2018
First Posted Date  ICMJE March 5, 2018
Last Update Posted Date October 9, 2018
Actual Study Start Date  ICMJE August 1, 2018
Estimated Primary Completion Date August 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Evaluating a Digital Memory Notebook App to Improve Functional Independence
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Mild Cognitive Impairment
Intervention  ICMJE
  • 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  ICMJE
  • 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.
    • 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 *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 26, 2018)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 30, 2021
Estimated Primary Completion Date August 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03453554
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Current Responsible Party Washington State University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Washington State University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE United States Department of Defense
Investigators  ICMJE
Principal Investigator: Maureen Schmitter-Edgecombe, PhD Washington State University
PRS Account Washington State University
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP