Satisfying Clinical Research Guidance and Regulations for mHealth Technologies

Brian Moyer¹, Christopher Whalen¹, Lisa Hoopengardner², Yentram Huyen³, Katie Watkins², Michael Holdsworth¹, Jiwen Sun⁴, Kevin Newell², Susan Vogel⁵, Ruma Das⁶, Alex Rosenthal³, Michael Tartakovsky^3
1Research Data and Communication Technologies, Inc,
USA;  ²Clinical Research Directorate/Clinical Monitoring Research
Program, SAIC-Frederick, Inc., Frederick National Laboratory for
Cancer Research, Maryland, USA; ³Office of Cyber
Infrastructure and Computational Biology, National Institute of
Allergy and Infectious Diseases, National Institutes of Health, USA; ⁴Dell Services, Federal Government, USA; ⁵Regulatory Compliance and Human
Subjects Protection Branch, Division of Clinical Research, National
Allergy and Infectious Disease, National Institute of Health, USA; ⁶Dell-PSGS – Efficiency
System Technology Inc. USA

Journal MTM 1:4S:33, 2012
DOI:10.7309/jmtm.55

Abstract

The Office of Cyber Infrastructure and Computational Biology (OCICB) of the National Institute of Allergy and Infectious Diseases (NIAID) at the NIH has been developing a solution that complies with current guidance frameworks and regulatory requirements while leveraging the potentials offered by mHealth technologies for data collection. OCICB has designed an mHealth solution that maps to the paper processes developed over the past century for clinical research. We designed the system for use in regions of low to middle-income countries where the patients often have no other clinical record. For our pilot, we selected a natural history study that does not have the same regulatory requirements as an Investigational New Drug (IND) study. We retained our existing paper-based clinical data capture management system in order to compare quality control reports between paper-based and mobile electronic capture methods. The solution complies with regulatory frameworks and requirements such as Good Clinical Practices and 21 CFR Part 11, which requires full audit trails of the data collection process at the source and the validation stages. It also provides the capacity for workflows that support the data validation process within the field research framework. We expect to show that the accuracy of data collection improves using mobile source data collection. This will reduce the time and cost of validating the collected data before final analysis for clinical research while maintaining the regulatory framework that protects patient interests. The solution will further provide clinical monitors with the ability to remotely access the source data and thus reduce the cost of travel for monitoring as well as reducing the impact on patients due to mistakes made while entering the data.

Use of SMS text for Maternal and Child Health Surveillance in resource constrain setting

Momin Kazi¹,Murtaza Ali¹,  Anita Zaidi^1
1Aga Khan University, Pakistan

Journal MTM 1:4S:46, 2012
DOI:10.7309/jmtm.67

Abstract

Background: Department of Paediatrics and Child Health, Aga Khan University, Karachi, conducts active demographic surveillance system (DSS) for maternal and child health at a peri urban site of Karachi, covering an area of 8.1 sq. miles and having a population of around 275,000. The maternal mortality rate (MMR) is around 200 per 100,000 live births. There are around 300 neonatal and 150 post neonatal deaths in the study catchment area. We introduced a two way SMS based pregnancy and birth registration system in the surveillance catchment area.

Method: Community health workers (CHWs) visit household on quarterly bases in the study catchment area to identify new pregnancies and follow the pregnant woman until their pregnancy outcome. As soon as CHW identifies a pregnant woman, she sends a SMS message to the server. Based on this registration, system generates follow up details of each pregnant woman; giving priority to third trimester. Once live birth identified CHW sends a SMS to the server which alerts the team to examine the neonate.

Results: This system helps in early identification and monitoring of pregnant woman and newborns. Also by sending unique structure identifier through SMS to the server, our CHWs and study staff can get desired information of the pregnant woman and children less than 5 years of age in the study surveillance area.

Conclusion: Through SMS registration we have an extra layer for identifying maternal death and pregnancy outcome. Identifying a woman / child information through SMS is also quite helpful.

SMS Text Messages to Monitor the Coverage during Polio Supplementary Immunization Activities in Karachi, Pakistan

Momin Kazi¹,Shariq Khoja¹,Murtaza Ali¹,  Asad Ali^1
1Aga Khan University, Pakistan

Journal MTM 1:4S:45, 2012
DOI:10.7309/jmtm.66

Abstract

Background: Karachi is the only major city in the world that has not been able to interrupt wild type polio transmission. Supplementary Immunization Activities (SIAs) are an important tool by which countries have sought to increase polio immunization coverage. However, more than 50 SIAs have so far failed to interrupt the transmission of poliovirus in Karachi. Cell phone use has seen a tremendous rise in Pakistan with more than 110 million subscribers. In this study, we are using the wide network of cell phone to monitor the coverage rates during SIAs in Karachi, Pakistan.

Methods: 3535 children less than 5 years old from all over Karachi and three high risk towns where included in the baseline data.The baseline survey included information on basic demographics, short message service (SMS) language preferences and household’s GPS coordinates on a smart phone. After each SIA, a randomly selected 840 households are contacted via SMS inquiring if the vaccinator came to their house and whether their child received vaccine dose or not. In case there is no reply by SMS, same information is captured by phone call. The study will continue till 2013.

Results: A total of 3562 children consented for the baseline study. Out of 840 SMS sent after the first second and third SIA 62 (7%), 189 (23%) and 158 (19%) respectively replied to the SMS. 561 (67%), 374 (44%) and 394 (47%) respectively replied to phone call and 217 (27%), 277 (33%) and 288 (34%) respectively did not reply to SMS or phone call.

Conclusion: The coverage data obtained through the SMS text and phone call replies matches with the data collected through ground team monitoring and other methods like LQAs. SMS based surveillance can be a way to determine population level coverage of polio immunization in a very short time period and this system can be upgraded to country level.

Results of Communication Enhancement Used in eIMCI Decision Support for the Treatment of Children Under Five in Tanzania

Seneca Perri¹, Bethany Hedt², Thomas Routen³, AmaniShao⁴, Clotilde Rambaud-Althaus⁵, Ndeniria Swai⁶, Marc Mitchell^2
1University of Utah, Salt Lake City, UT, United States, ²Harvard School of Public Health, Boston, MA, United States, ³Thingsprime, Freiburg, Germany, ⁴National Institute of Medical Research, Dar es Salaam, United Republic of Tanzania, ⁵Swiss Tropical and Public Health Institute, Basel, Switzerland, ⁶City Medical Office of Health, Dar es Salaam, United Republic of Tanzania

Journal MTM 1:4S:44, 2012
DOI:10.7309/jmtm.65

Abstract

The use of standardized decision support protocols have been shown to improve the quality of health service delivery in pediatric patients of low-resource populations if appropriately followed. However, even when clinical services are good, low levels of health literacy levels among caretakers of children may compromise the fulfillment of treatment plans. This study examines whether the use of mobile technology can improve the impact of counseling of children’s caretakers and result in better understanding of what needs to be done at home after the clinical visit and whether this results in better care of the child.

Utilizing mobile technology, we attempted to address the gap in communication during pediatric health care visits by incorporating specific, customized communication prompts into an eIMCI mobile decision support protocol. We utilized a randomized cluster design to include 310 participants from six municipal clinics in Dar es Salaam, Tanzania. The test arm of the study (electronic arm) included a 25-second video formatted for the mobile phone aimed at educating caretakers on relevant health information, embedded prompts within the protocol containing important messages for caretakers, and a customized summary screen compiling the results of the clinical encounter. The control arm (paper arm) provided equivalent information to the electronic counseling messages in written text as part of the protocol. The counseling delivered by health workers and resulting caretaker knowledge were evaluated by an observer and a short questionnaire of the caretakers after the clinic visit. Our research demonstrated that clinicians provided significantly more counseling to caretakers when using the electronic mobile protocol and caretakers were overall better able to recall what they were supposed to do when they returned home. We believe these results are highly valuable to the greater mHealth community seeking to improve the chain of health service delivery for low-resource populations.

Prescribe Wellness Automated Digital Intervention (ADI) Effectiveness to Increase Medication Adherence

Terry Olson^1
1Prescribe Wellness

Journal MTM 1:4S:43, 2012
DOI:10.7309/jmtm.64

Abstract

Medication non-adherence is pervasive within all areas of the U.S. health care system. Non-adherence has been estimated to range between 17 and 80%: involving 38% of patients on short-term treatment, 43% of patients on long-term treatment, and 75% of patients instructed to make a lifestyle change (DiMatteo, 1994). Approximately 133 million Americans, almost half of the country’s population, live with at least one chronic disease (CDC, 2010). It is estimated that by 2020, 164 million people will be diagnosed with a chronic disease, and 24% of all Americans will have two or more chronic conditions (CDC, 2010). Improving medication adherence can have a great potential to contribute to effective chronic disease state management and overall better health outcomes.

Prescribe Wellness, LLC partnered with leading local pharmacies in the Greater Los Angeles area to create a supplemental Automated Digital Intervention (ADI) to be used with patient-centered Medication Therapy Management (MTM) sessions. This proprietary first generation ADI template, aimed to increase medication adherence through the pharmacy’s intervention process, sends out appropriate motivational, behavioral, and educational messages through timely and relevant communications using the Voice of Authority (VOA).

The purpose of this quantitative study was to determine whether a relationship exists between the PrescribeWellness’ ADI and patient medication adherence. The relationship between variables was examined by implementing descriptive statistics and Chi-squared analysis. Pharmacy patients (n=12) were taken through a standard MTM session followed by ADI voice messaging during the subsequent 90-day period. Results showed there was an association between PrescribeWellness’ ADI and patient medication adherence, as medication adherence rates increased from 66.7% to 85.7%. Additional findings showed there was an increase in adherence rates for those patients with chronic conditions of hyperlipidemia (60% to 93.3%), hypertension (76.2% to 90.5%) and diabetes (47.6% to 57.1%).

A Qualitative Analysis of Emergency Department Patients’ Experiences with TExT-MED, a Text-message Based mHealth Program to Improve Diabetes Management

Elizabeth Burner,¹Sanjay Arora,¹  Elena Taylor,²  Michael Menchine^1
1Keck Medical School of USC Department of Emergency Medicine ²USC Memory and Aging Center

Journal MTM 1:4S:42, 2012
DOI:10.7309/jmtm.63

Abstract

Background: In the United States, diabetes plagues Latinos, and their diabetes can be difficult to manage due to cultural, language and access barriers. The extent of benefits from mHealth technologies to improve the management of diabetes among low-income Latinos is currently unknown. Understanding the complex changes to self-efficacy and health beliefs can be difficult to measure quantitatively, especially in minority populations were traditional health belief models may not translate well culturally.

Methods: A text-messaged based educational and motivational program designed to improve disease knowledge, self-efficacy and glycemic control among low-income, inner-city Latinos was piloted for feasibility. Self-efficacy, diabetes knowledge and frequency of healthy behaviors were measured at the start and end of the trial. Focus groups were then convened to explore patient experiences with the program, and the program’s impact on patients’ self-efficacy and health beliefs. The findings of these sessions were used to reanalyze the quantitative data measured previously in the study.

Results: 23 patients were recruited for the feasibility study. Through qualitative analysis, we found thatmen and women had different information sources and differing self-efficacy towards diet management. Using this knowledge, the quantitative data gather was stratified by gender, and differential changes were noted between genders in diabetes knowledge, self-efficacy and healthy food choices.

Conclusions: Men and women have differences in self-efficacy towards diet management and information sources. These differences may affect the effectiveness of mHealth interventions to improve diabetes. Gender and culture should be considered when designing interventions to achieve maximal impact.