Integrated Web-Based Customer Engagement, Physical Exercise, and Coaching Platform for Older Adults

NCT03644745 | Unknown DMC

• 1 other identifier: R43AG057337
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Aging

Keywords

Aging

Outcome Measures

Primary Outcomes (1)

• 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

  At baseline (week 1) and again in the final week (week 12)

Secondary Outcomes (6)

• Change in mood

  At baseline (week 1) and again in the final week (week 12)

• User satisfaction

  Post participation (Week 12)

• Self-efficacy

  At baseline (week 1) and again in the final week (week 12)

• Adherence to goals

  weekly (weeks 1-12)

• Level of socialization

  At baseline (week 1) and again in the final week (week 12)

Study Arms (1)

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.

Behavioral: VM @ Home Usability

Interventions

VM @ Home Usability BEHAVIORAL

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.

VM @ Home Usability

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Northeastern University: lead

Study Sites (2)

New Bridge on the Charles

Dedham, Massachusetts, 02026, United States

Location

Maplewood Senior Living

Weston, Massachusetts, 02493, United States

Location

Related Links

• Vigorous Mind, Inc. website
• Consortium on Technology for Proactive Care (research group at Northeastern University)

Study Officials

• Holly B Jimison, PhD

  Northeastern University

  STUDY DIRECTOR

• Yuval Malinsky

  Vigorous Mind, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Director, Office of Human Subjects Protection

CONTACT

(617) 373-4588; irb@northeastern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 15, 2017
• First Posted: August 23, 2018
• Study Start: September 1, 2018
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: August 23, 2018

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)