AgingNCT03644745
Integrated Web-Based Customer Engagement, Physical Exercise, and Coaching Platform for Older Adults
A study testing VM @ Home Usability in people with Aging, run by Northeastern University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- VM @ Home Usability
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2018to 1 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- Uncorrected vision or auditory impairment
- Cognitive impairment (MoCA<27)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
New Bridge on the Charles
Dedham, Massachusetts, 02026
Stephen Colwell, 781-234-9011
Maplewood Senior Living
Weston, Massachusetts, 02493
Andrea S Ellen, 203-557-4777
About this study
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.
Read the 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.
- Conditions
- Aging
- Being tested
- VM @ Home Usability
- Keywords
- Aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VM @ Home UsabilityBehavioural
Our primary outcome measures will be use of the coaching system features, level of daily physical activity, mood, self-efficacy, and user satisfaction. Secondary outcomes that will inform our further development and be important outcomes in subsequent trials include user adherence to their coaching goals, physical function and level of socialization. For the pilot study, we plan to assess physical function and level of socialization at baseline and at the end of 3 months. For the other outcome measures, we will be able to integrate the data collection into the VM@Home platform and coaching process.
| Study group | Role | What they receive |
|---|---|---|
| VM @ Home Usability | Experimental | We will pilot our customer engagement and physical exercise system in the homes of up to 20 participants for 3 months. Participants will interact with the system on their own computers, smart phones, and/or televisions and wear an activity tracker throughout the study. Interactions include physical exercise, system usage, and video conferencing. Receives: Behavioral: VM @ Home Usability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in level of physical activity
Change in daily average number of steps from baseline week 1 to final week (up to 16 weeks, depending on trial phase) as measured by Fitbit
Measured: At baseline (week 1) and again in the final week (week 12)
Secondary outcomes (6)
Change in mood
Change in mood score from baseline to completion using PANAS
Measured: At baseline (week 1) and again in the final week (week 12)
User satisfaction
User rated satisfaction with system as measured by the Client Satisfaction Questionnaire adapted to Internet-based interventions (CSQ-I)
Measured: Post participation (Week 12)
Self-efficacy
Change in user rated self-efficacy as measured by the Generalized Self-Efficacy Scale
Measured: At baseline (week 1) and again in the final week (week 12)
Adherence to goals
Change in percentage of cumulative assigned activity completion (number of minutes using/number of minutes scheduled) as measured by the VM@Home system
Measured: weekly (weeks 1-12)
Level of socialization
Change in social network score, measured at baseline and again at the end of participation as measured by the Ludden Social Network Scale
Measured: At baseline (week 1) and again in the final week (week 12)
Usability
Change in user rated usability and ease of use of system as measured by the Brooke System Usability Scale (1996)
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start1 Sep 2018 (estimated)
- Primary completion1 Sep 2019 (estimated)
- Study completion1 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northeastern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Holly B Jimison, PhD, Study director, Northeastern UniversityYuval Malinsky, Principal investigator, Vigorous Mind, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03644745
- Sponsor's protocol ID
- R43AG057337
- Status last verified
- Aug 2017
- First submitted
- 15 Aug 2017
- Last updated
- 23 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share IPD with other researchers. This is usability testing for a small business innovation award with a small study population; sharing data under these circumstances would be inappropriate.
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Web-Based Customer Engagement, Physical Exercise, and Coaching Platform for Older Adults
- ClinicalTrials.gov ID
- NCT03644745
- Acronym / sponsor ID
- R43AG057337
- Conditions
- Aging
- Keywords
- Aging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Northeastern UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (estimated)
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 1 Sep 2019 (estimated)
- First posted
- 23 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| VM @ Home Usability | Experimental | Behavioral: VM @ Home UsabilityWe will pilot our customer engagement and physical exercise system in the homes of up to 20 participants for 3 months. Participants will interact with the system on their own computers, smart phones, and/or televisions and wear an activity tracker throughout the study. Interactions include physical exercise, system usage, and video conferencing. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Uncorrected vision or auditory impairment
- Cognitive impairment (MoCA<27)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VM @ Home UsabilityOur primary outcome measures will be use of the coaching system features, level of daily physical activity, mood, self-efficacy, and user satisfaction. Secondary outcomes that will inform our further development and be important outcomes in subsequent trials include user adherence to their coaching goals, physical function and level of socialization. For the pilot study, we plan to assess physical function and level of socialization at baseline and at the end of 3 months. For the other outcome measures, we will be able to integrate the data collection into the VM@Home platform and coaching process. | Behavioural | VM @ Home Usability |
Primary outcome
Change in level of physical activity
Time frame: At baseline (week 1) and again in the final week (week 12)
Change in daily average number of steps from baseline week 1 to final week (up to 16 weeks, depending on trial phase) as measured by Fitbit
6 secondary outcomes
Change in mood
Time frame: At baseline (week 1) and again in the final week (week 12)
User satisfaction
Time frame: Post participation (Week 12)
Self-efficacy
Time frame: At baseline (week 1) and again in the final week (week 12)
Adherence to goals
Time frame: weekly (weeks 1-12)
Level of socialization
Time frame: At baseline (week 1) and again in the final week (week 12)
Usability
Time frame: Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2018.
- Vigorous Mind, Inc. websiteLink provided by the sponsor.
- Consortium on Technology for Proactive Care (research group at Northeastern University)Link provided by the sponsor.
- Individual participant dataSharing planned: No. We do not plan to share IPD with other researchers. This is usability testing for a small business innovation award with a small study population; sharing data under these circumstances would be inappropriate.
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Aging
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Holly B Jimison, PhD study director
Northeastern University
Yuval Malinsky principal investigator
Vigorous Mind, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VM @ Home Usability in people with Aging, run by Northeastern University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Director, Office of Human Subjects Protection ((617) 373-4588, irb@northeastern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in level of physical activity (time frame: At baseline (week 1) and again in the final week (week 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2018.