Rationale:  Enrolling subjects for longitudinal research studies, ensuring their compliance and retaining them over a period of time pose a significant challenge to researchers. As an example, we had 62% and 30% retention at years 1 and 3 in a recently concluded study on knee osteoarthritis. To overcome these challenges and to optimize workflow associated with data acquisition, quantification, we have developed a design which combines multiple computing platforms to create a seamless, user-friendly experience for all participants (researcher and subject).  The platforms [using  Ruby on Rails (RoR),  PostgreSQL, iOS  and representational state transfer (RESTful) API]  are designed to enable researchers and subjects to complete data acquisition forms and surveys on tablets which then get quantified and submitted to our cloud servers. Qualitative data show improved subject satisfaction compared to paper forms, reduced paper use by researchers and study coordinators, reduction in man-hours by researchers and study coordinators to manually quantify survey scores and input data into the database and better quality control.

Based on these initial experiences using mobile technology for enhancing subject’s participatory experience and streamlining associated workflow, we propose – (1) the expansion of our current platform to UCSF Imaging clinics (for recruitment and improving care experience), (2)  a one year research study on obese individuals examining effect of weight-loss on knee tissue health using quantitative imaging. This will enable us to analyze the efficacy of the platform towards maintaining compliance and increasing retention. (3) Additionally, we also intend to pilot a networked module incorporating social gaming and feedback principles to assess behavior modification in this population which is of special interest to our lab for our research on knee osteoarthritis prevention.

PLAN:  Recruitment component: (1) Over the 1^st three months, enhance the current tablet computer applications to include    interactive versions of intake forms, standardized questionnaires, as well as, modules which simulate the procedure to be performed (MRI, CT, radiography) to address common issues like claustrophobia, restricting movement during scanning etc.. This module will also offer the patients to learn about unique capabilities of the UCSF Imaging centers (safety regulations, metal suppression sequences, quantitative imaging capabilities, other research studies which offer volunteer opportunities) along with a brief bios of the personnel who will be interacting with the patients during their procedures.  While the patients learn about the UCSF imaging capabilities, they will have the option to explore ongoing research participation opportunities  and, if interested, sign up to be contacted by a study coordinator. We have multiple longitudinal trials underway at the moment which will benefit from this mode of recruitment. Possibility of using mHealth frameworks implemented at UCSF will be explored to allow for future adaptability across other UCSF departments. (2) Over months 3-9, administer the tablets to all patients at the UCSF imaging centers (Orthopedic Institute, China Basin Landing and Mission Bay) scheduled for musculoskeletal imaging for clinical or research purposes.

Retention and gaming component: (1) Over months 4-12, twenty-five adult obese subjects from the UCSF- Weight Management Program will be recruited. These subjects will undergo MR imaging at baseline and 6 months, 9 months for quantification of knee tissue health using our standardized metrics. At each time point, subjects will complete surveys related to their levels of physical activity, nutritional data, and incidence of musculoskeletal pain/injuries every month. Additionally, the subjects will complete surveys  remotely using mobile applications (described later) every 6 weeks. (2) Over the 1^st three months, develop mobile phone applications for surveys and a “gamified” feature where the research participants can track their scores (levels of physical activity, functional status, pain status, calorie intake) and compare it to other participants, promoting increased participation of physical activity using competitive motivation. A virtual character will be designed (eg: an alien trying to reach home planet) and the participant  will need to complete all study associated tasks, as well as, maintain a certain level of physical activity, consume the recommended diet to enable the character to succeed at the game. Periodically, information on the benefits of the interventions will be incorporated, feedback on the performance with resulting improvements will also be provided and quizzes on weight-management will be incorporated. These approaches have been shown to be effective in management of diabetes, improving physical activity in children and improving walking capacity in adults to cite a few (1-3).

Long term plan: This pilot will be used to demonstrate feasibility, efficacy and flexibility of the platform using UCSF Imaging clinics and research. In the next phase, an NIH application will be submitted for a larger, longer research project where the platform will be implement in obese individuals undergoing surgical and non-surgical weight-loss and followed-up for four years. Eventually, the platform will be made available to all UCSF researchers interested. Recruitment and clinic modules will be made available to other interested UCSF departments immediately. 

Criteria and metrics for success: (1) Percentage of participants enrolled in research studies from the UCSF imaging centers (currently unknown) (2) Clinic patients and research participants will be invited to complete an online survey assessing their satisfaction with their experience, likelihood to stay in the research study and likelihood to return to UCSF for future appointments. (3) Retention in the research studies over a one year period will be compared to retention in all of our other longitudinal studies. (4) Impact of weight-loss on changes in composition of knee articular and meniscal cartilage using quantitative imaging, intramuscular fat content of thigh muscles, levels of physical activity, amount of weight-loss will be assessed at one year.

Approximate Costs and Justification: Total Budget = $95,350; 2 Tablet computers for development @ $400 ea. = $800; 20 Tablet computers for deployment @ $400 ea.    = $8,000; 15% effort from the PD/PI  (Dr. Kumar)  = $8,550; 25% effort from QUIP-C software developer over the year = $25,000; Consultant fees for gamification of the applications =  $25,000; Partial costs for MR imaging of research participants (shared with other grants)  = $28,000

Collaborators:  Deepak Kumar (MQIR); Vivek Swarnakar (QUIP-C), Sharmila Majumdar( MQIR), MQIR), David Dean ( QUIP-C), Richard Souza (MQIR), TBD(Game developer)  

REFERENCES:

1)      Aoki N, Ohta S, Masuda H, Naito T, Sawai T, Nishida K, Okada T, Oishi M, Iwasawa Y, Toyomasu K, Hira K, Fukui T. Edutainment tools for initial education of type-1 diabetes mellitus: initial diabetes education with fun. Stud Health Technol Inform. 2004;107(Pt 2):855-9.     

2)      Southard DR, Southard BH. Promoting physical activity in children with MetaKenkoh. Clin Invest Med. 2006. 29(5):293-7.

3)      Consolvo S, Everitt K, Smith I, Landay JA. Design requirements for technologies that encourage physical activity. In: Grinter R, Rodden T, Aoki P, Cutrell E, Jeffries R, Olson G, editors. Proceedings of the SIGCHI Conference on Human Factors in Computing Systems; 2006 Apr 22-27; Montreal, Quebec, Canada. New York: ACM; 2006. p. 457-66.