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Evaluating a Digital Memory Notebook App to Improve Functional Independence

Primary Purpose

Mild Cognitive Impairment

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Digital Notebook app
Smart Home Prompting
Sponsored by
Washington State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mild Cognitive Impairment focused on measuring technology, activities of daily living, everyday functioning, quality of life, memory impairment

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Washington State University - PullmanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DMN/Smart Home Partnership

Digital Memory Notebook app

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
Caregiver Burden
The Caregiver Burden Scale (CBS; Elmstahl et al., 1996) will be used to assess caregiver burden experienced by participants' care-partners.

Secondary Outcome Measures

Coping self-efficacy
The Coping Self Efficacy Scale (CSES) assesses participants' perceived abilities to cope with life challenges.
Cognitive functioning
Neuropsychological assessment: Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

Full Information

First Posted
February 7, 2018
Last Updated
October 4, 2018
Sponsor
Washington State University
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT03453554
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
August 30, 2021 (Anticipated)
Study Completion Date
August 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington State University
Collaborators
United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
technology, activities of daily living, everyday functioning, quality of life, memory impairment

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DMN/Smart Home Partnership
Arm Type
Experimental
Arm Description
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.
Arm Title
Digital Memory Notebook app
Arm Type
Active Comparator
Arm Description
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 Type
Other
Intervention Name(s)
Digital Notebook app
Intervention Description
Training in use of Digital Memory Notebook app
Intervention Type
Other
Intervention Name(s)
Smart Home Prompting
Intervention Description
Smart-home sensor based activity-aware prompting to support digital memory notebook app use
Primary Outcome Measure Information:
Title
Digital Memory Notebook Use
Description
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.
Time Frame
Change will be assessed between monthly time points (1-, 2-, 3-, 4-, and 5-months).
Title
Quality of Life
Description
The Quality of Life-Alzheimer's disease (QOL-AD; Logsdon, 1996) scale will be used to measure quality of life and subjective well-being.
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).
Title
Activities of Daily Living
Description
The Instrumental Activities of Daily Living- Compensation (IADL-C; Schmitter-Edgecombe, Parsey, & Lamb, 2014) will be used to provide an estimate of functional difficulties.
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).
Title
Caregiver Burden
Description
The Caregiver Burden Scale (CBS; Elmstahl et al., 1996) will be used to assess caregiver burden experienced by participants' care-partners.
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).
Secondary Outcome Measure Information:
Title
Coping self-efficacy
Description
The Coping Self Efficacy Scale (CSES) assesses participants' perceived abilities to cope with life challenges.
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)
Title
Cognitive functioning
Description
Neuropsychological assessment: Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Time Frame
Total change in cognitive functioning as measured by RBANS (total score) at baseline and end of intervention (6 Months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maureen Schmitter-Edgecombe, PhD
Phone
5093350170
Email
schmitter-e@wsu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie Saltness, B.S.
Phone
5093354033
Email
stephanie.salthness@wsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maureen Schmitter-Edgecombe, PhD
Organizational Affiliation
Washington State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington State University - Pullman
City
Pullman
State/Province
Washington
ZIP/Postal Code
99164-4820
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maureen Schmitter-Edgecombe, PhD
Phone
509-335-0170
Email
schmitter-e@wsu.edu
First Name & Middle Initial & Last Name & Degree
Stephanie Saltness, BA
Phone
5093354033
Email
stephanie.saltness@wsu.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34776442
Citation
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.
Results Reference
derived
PubMed Identifier
31046586
Citation
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.
Results Reference
derived

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Evaluating a Digital Memory Notebook App to Improve Functional Independence

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