MENTIS Personal Health Record Rapid Pilot Research Deployment and Evaluation
Recruitment status was: Recruiting
Autism Spectrum Disorder (ASD) is a collection of complex neurodevelopmental disorders characterized by qualitative impairments in socialization, communication, and circumscribed interests, including stereotypical behavior patterns and behavioral rigidity to changes in routines (American Psychiatric Association, 1994). ASD is the fastest growing pervasive developmental disorder of childhood, currently estimated to affect 1 in 88 school age children (Baio, 2012). ASD typically manifests in infancy and persist throughout the lifespan. There is no known cause or cure for ASD, yet structured behavioral interventions and medications can enhance developmental outcomes. ASD has a profound impact on families and often result in enormous emotional and financial costs. Recent estimates suggest that societal costs in the US to care for all individuals diagnosed each year over their lifetime approaches $35 billion (Ganz, 2007).
Janssen Research & Development is building a comprehensive digital platform (MENTIS) to optimize and enhance development of novel medicines and track outcomes in individuals with ASD. The MENTIS platform contains several core components, including: (1) An electronic personal healthcare record, designed specifically for individuals with ASD and their caregivers (parents, teachers, healthcare providers); (2) Integrated physiological and physical activity biosensors designed to objectively assess outcomes important in ASD, and; (3) A de-identified research data warehouse with analytic tools to better measure outcomes, assist with sub-population identification, and identify algorithms for diagnosis and treatment response detection.
The MENTIS platform is currently being designed, developed, and prepared for testing. During this process it is highly desirable to conduct feasibility and usability research with a sample of the target population to identify important system components and features, optimize design, and reduce redundancy in software development and research time. The rapid pilot study described herein is proposed to gather incipient feedback on select MENTIS system components and features from stakeholders who support individuals with ASD in a clinical setting. This pilot research will help evaluate both how well current MENTIS system features work in an applied setting and inform future directions for MENTIS platform development.
|Study Design:||Observational Model: Ecologic or Community
Time Perspective: Prospective
|Official Title:||MENTIS Personal Health Record Rapid Pilot Research Deployment and Evaluation|
- Self-Report [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Summary of data from all data collection cycles (includes Stakeholder entered data, biosensor data and passive system usage data) in aggregate and raw, de-identified dataset with both qualitative and quantitative information:
- Qualitative and quantitative data from Exit Interviews
- System usage data;
- Pre-post summary,
- case examples,
- de-identified video examples,
- overall results.
|Study Start Date:||November 2013|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02090491
|United States, New York|
|Center for Discovery|
|Harris, New York, United States, 12742|
|Principal Investigator:||Matthew S Goodwin, PhD||Northeastern University|