Clinical trial NCT03644745: Integrated Web-Based Customer Engagement, Physical Exercise, and Coaching Platform for Older Adults
Official title: Integrated Web-Based Customer Engagement, Physical Exercise, and Coaching Platform for Older Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aging
Keywords: Aging
Lead sponsor: Northeastern University
Sponsor class: OTHER
First posted: 2018-08-23
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The first 5 volunteers will be assigned for the preliminary in-home deployment to test the usability and provide feedback to potentially refine the system. Researchers will provide each participant with an activity tracker and download the required software on the participant's computer and smart phone. After 1 week, two researchers will conduct a home visit to provide the participant with a brief introduction to the system. Participants will interact with the system for 30 days while researchers use protocol analysis to record usability issues. All interactions with the system will be recorded. After 30 days, we will conduct an interview with the participant designed to uncover issues. The outcome measures described below will also be recorded. After necessary changes to the engagement and coaching system are made, we will deploy the system in an additional 15 homes for 3 months.
Primary purpose: OTHER

Brief summary: The fast-growing older population coupled with the worsening shortage of caregivers and nurses will soon present our nation with severe societal and economic challenges. Older adults often struggle to maintain quality of life and independence in the presence of chronic diseases and isolation. Physical exercise and socialization have been shown to reduce chronic disease, depression, falls and to improve quality of life in older adults. Motivation and feedback are essential to continued engagement in a wellness program, but doing so through the traditional manner of in-person coaching can be prohibitively expensive. Vigorous Mind (VM) has been providing a web-based platform to promote sustained engagement in older adults primarily in senior living facilities. The platform provides dynamic and tailored content including reminiscence activities, favorite music and video, adaptive computer games and communication. With the help of the Consortium on Technology for Proactive Care, the investigators will enhance the current VM system with an additional interactive physical exercise module and a health coach with automated tailored messaging and incentives for continued engagement and adherence. This will optimize the VM system for home-based deployment, thus expanding the reach and impact of VM to potentially delay or even prevent institutionalization among older adults living independently.

Detailed description: The goal of the proposed project is to test the feasibility of deploying an economically feasible, machine-assisted, home-based wellness coaching system for older adults. Our approach consists of four sub-phases: (1) development, (2) usability, (3) preliminary deployment, and (4) pilot evaluation and analysis. The investigators estimate that the investigators will complete this project plan within 9 calendar months.

Sub-phase 1: Development \[3 months and 3 weeks\]. During sub-phase 1, the investigators will focus on software development activities at both VM and NU. There are 2 deliverables resulting from this sub-phase:

Build coaching interface. VM has an administrator interface that facilitates the design, assignment to users and adherence monitoring of a cognitive exercise plan. Using NU's experience and expertise, our developers will broaden the VM functionality to include a physical exercise module that allows assignment of exercise plans to users, monitoring of users' adherence and social interactions, as well as the delivery of tailored feedback and encouragement. The reward system of VM which currently rewards engagement in a variety of activities will be adapted to also reward physical activity. VM will create a new user type for the coach that allows for data sharing and an ability to communicate with family and/or caregivers in addition to the participant.

Integrate GymCentral into VM. Developed by researchers at the University of Trento in Italy (an international member of the CTPC), the primary software developer is now a postdoctoral fellow at NU and key personnel on this grant application. GymCentral is a virtual training platform (virtual gym) specifically designed for older adults. The virtual gym delivers video exercises in a "classroom" where trainees can see the presence of other trainees as avatars and communicate with them. The virtual gym aims to boost older adults' social interaction and motivate them to adhere to physical exercises. Our team of developers will integrate this system with the VM platform so that GymCentral can be deployed and collect engagement data within the VM system.

Sub phase 2: Usability \[1 month\]. In sub-phase 2, VM will connect with several of its independent living community's clients that have agreed to help recruit 5 independently living older adults who have and use computers for a pilot study (recruiting details specified below). This group will serve as the early usability testers for the home version of the VM system (VM@Home) and provide iterative feedback for our developers. Each of these 5 individuals will be given VM@Home to use on their home computers for one month. During this month, each participant will be provided a wearable wrist accelerometer (e.g., Misfit), along with training on the devices and on VM@Home, engage regularly with the platform, and be contacted weekly by a health coach. The investigators plan to use an innovative remote usability testing approach developed and tested by our collaborator Dr. Jimison. The developer and tester team will periodically contact the participants, especially if any anomalies are detected. During the remote sessions, participants will be asked to interact with the VM modules (calendaring, messaging, brain games, and Web entertainment) and the new physical exercise module. The iterative usability feedback will be used to adapt the design of the system for deployment in Sub-phase 3.

Sub-phase 3: Pilot Test \[3 months\]. After usability testing has been completed and necessary changes implemented, the investigators will ramp up recruitment activities through existing VM clients who have agreed to participate in the study with the goal of deploying VM@Home in an additional 15 homes of independently living older adults in independent-living communities. The five individuals who were recruited for sub-phase 2 will be offered the opportunity to continue in the study as champions of the technology, for which the investigators will provide additional training and support. As champions, they will mentor those of the other 15 users who will need assistance. During this sub-phase, the investigators will measure system use (continuously), level of physical activity (daily from wearable), level of socialization (daily from monitoring and by survey at baseline and each month), and mood, self-efficacy, and user satisfaction all by self-report at baseline and each month.

At the end of the three months, the investigators will also debrief with each participant with a semi-structured interview to obtain overall feedback and suggestions. These debriefing sessions will help investigators and developers to enhance design specifications for a robust, reliable and effective integrated engagement and coaching system to provide guidance for the further development and testing in a much larger population in Phase II. This will include exploring best options for including reward systems for active participation.

Sub-phase 4: Analysis \[1 month\]. Although the investigators will be routinely analyzing the monitoring data from system use and daily activity feedback from the wearable activity tracker throughout the project for coaching purposes, the last month of the project will be devoted to analyzing the full set of primary and secondary outcomes, as well as the qualitative debriefing interviews. The results from this pilot will prepare us for a more expanded and more powerful intervention in our follow-on Phase II proposal.

Eligibility criteria: Inclusion Criteria:

* Living independently
* Able to read and speak English
* PCP approval to exercise
* Have a laptop PC or Windows based tablet
* Have WiFi in their home
* Have a smart phone with a data plan

Exclusion Criteria:

* Uncorrected vision or auditory impairment
* Cognitive impairment (MoCA\<27)

Primary outcomes:
measure: Change in level of physical activity
timeFrame: At baseline (week 1) and again in the final week (week 12)
Secondary outcomes:
measure: Change in mood
timeFrame: At baseline (week 1) and again in the final week (week 12)
measure: User satisfaction
timeFrame: Post participation (Week 12)
measure: Self-efficacy
timeFrame: At baseline (week 1) and again in the final week (week 12)
measure: Adherence to goals
timeFrame: weekly (weeks 1-12)
measure: Level of socialization
timeFrame: At baseline (week 1) and again in the final week (week 12)
measure: Usability
timeFrame: Week 12
Other outcomes:
Locations:
city: Dedham
country: United States
facility: New Bridge on the Charles
state: Massachusetts
city: Weston
country: United States
facility: Maplewood Senior Living
state: Massachusetts
Study officials:
affiliation: Northeastern University
name: Holly B Jimison, PhD
role: STUDY_DIRECTOR
affiliation: Vigorous Mind, Inc.
name: Yuval Malinsky
role: PRINCIPAL_INVESTIGATOR
References: