Clinical trials: Retention, compliance and mobiles

By Brian Dolan
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By Carmen R. Gonzalez, Manager of Strategy and Communications, HCG

Mobile GraphicWhen it comes to successfully completing clinical studies, keeping patients enrolled is crucial. Lengthy trials pose a significant risk of patients dropping out, especially if invasive procedures are involved. In studies that include add-on trials, every patient's continued participation grows even more valuable. In addition, making sure patients stay on course with all study requirements adds to this burden. While the need for effective retention and compliance measures is clear, they must be targeted to do the job. That's where mobile technologies can play an effective role.

Over the past several years, messaging services have grown quite sophisticated in offering text, email, and phone reminders, many specializing in medical compliance. Some services allow for various language translations and the integration of voice recordings of hospital staff or a patient's family members, delivered on schedules dictated by patient preferences. Today, the mobile tech arena has sufficiently ripened to lend a hand with clinical trial patient retention and compliance.

With proper IRB approval, there are several ways to use mobile technologies to assist with subject retention and study adherence. Here's an overview of possibilities, some in current use already:

Visit Reminders: With busy lives already, trial participants need not experience further complications with having to remember study appointments. Sponsor companies are well advised to adopt automated reminder call programs to ensure study visit adherence.

Compliance Reminders: Consider providing assistance using phone and texting reminders where complicated trial devices or drug dosing instructions are involved. Each message is an opportunity to eliminate an educational deficit. While patients can calibrate the degree of assistance they think they need, the offer of such support goes a long way to ensuring compliance. In one study, text messaging of motivational messages was shown to positively influence diabetes control and study adherence.

Dosing Reminders: Related to the previous point, patients are helped to maintain their drug schedules through the use of mobile tech alerts. From voice to text messages to email, clinical sites can stay in contact with their patients and know they are lending a helping hand with their study participation.

Dialoguing Assistance: Chat with patients to lend medical advice. Researchers from Edinburgh recently deployed a program entitled "Sweet Talk" to support young patients with diabetes between clinic visits using mobile phones. Over the course of a year, 64 patients, ranging in age between 8 and 18, were randomized into a controlled trial and had their messages recorded. Though the study was primarily designed to send reminder messages, it became a "trusted medium"(the researcher's words) by patients to communicate with their care providers.

Patients who needed clarification on questions they didn't feel comfortable asking in a clinical setting chose Sweet Talk (e.g. "Cld DiaBT's get their belly pierced"). Requests for supplies and confirmation on appointments were commonly made by patients. Users also provided more personal aspects about their lives, addressing topics they read in the study newsletter (e.g. relating to celebrities with diabetes, chocolate manufacturers offering sports tokens, and updates on diabetes research). As today's youth grow older and as mobile technologies become more ubiquitous in society, studies like this demonstrate that there is a role for messaging systems in health care and the clinical trial setting.

Educational Support: Where difficult or complex trial procedures exist, study leaders might consider offering previews and tutorials via text, email, or voice messaging to patients to clarify obscure or technically arcane issues. Given the clarification messages shared between patients and health care staff in the "Sweet Talk" study mentioned above, mobile technology can be used to offer instantaneous assistance to patients as well.

Self-monitoring Tool: Use mobile technology to track progress and activity completion. For example, in weight-loss studies where adherence to a diet and/or exercise program is included, self-monitoring can advance both activities. Research has shown that self-monitoring improves awareness of caloric intake, promotes monitoring of progress and improvement over time. The drawback to self-monitoring has been stress, the absence of social support, and inconveniences created by recording procedures-negative barriers that impede successful follow-through.

In a recent study performed by University of California, San Diego scientists, Kevin Patrick, M.D., and his team used mobile phones to improve behaviors, including self-monitoring through the use of text messages. Dr. Patrick's team proved that patients who received daily text messages as a means of guiding behavior, providing support, and promoting self-monitoring, outperformed patients receiving standard weight control advice in achieving their weight loss goals. By the end of the four-month study, 4.38 lbs. more weight was lost by the intervention group than the control group. Plus, every kilogram of weight loss was associated with a 13% drop in the risk of incident diabetes!

Traditional forms of patient monitoring (e.g. hardcopy diaries) can be improved with mobile technology too. By adapting diary delivery through mobile channels (e.g. voice or email surveys), patients may be assisted in promptly and more conveniently completing such tasks, with clearer recollection given real-time reply.

Transportation: Travel expenses can undo faithful study attendance of the most conscientious patients. Pre-visit mobile messages can help identify patients who need transportation assistance and prevent appointment cancellations. While this idea requires study sponsors to consider a transportation element in their retention plan, it can still be used where no provision has been made for travel vouchers or reimbursements. Reminders can prompt patients to contact their loved ones or friends for rides and/or offer information on the nearest public transportation access routes.

Placebo mitigation: Deploy mobile messages to help dampen the possibility of placebo response. For example, create messages that remind patients of the differing roles between research and medical care providers, the importance of placebo, and of possible hidden expectations that they may harbor. Messages may encourage patients to truthfully report their treatment responses and liken their role to that of product testers, placing great weight on accuracy and honesty. While such communications can take place during site visits, the benefit of using mobile messages is that the script is IRB-approved and consistently applied.

Intercept potential drop-outs: The use of reminders, coupled with confirmation messages from patients, helps to flag potential drop-outs. Site staff can respond to patients right away who fail to confirm visits or reply as requested in reminder messages. By investigating at the first sign of possible study withdrawal or lack of interest, site staff can help prevent retention problems.

Raise Efficiency of Patient Tracking: Messaging technology offers a communications footprint for performance evaluation. By reviewing how well messages served as reminders, you can determine what channel worked best (email, voicemail, texting) to promote retention. Moreover, the content itself can be evaluated to figure out what messages were most effective in retaining patients-valuable intelligence that can be repurposed for future studies.

While retaining patients will remain a concern for every clinical trial team, mobile technologies now provide a means to ease that burden.

Carmen R. Gonzalez is the Manager of Strategy and Communications at Healthcare Communications Group (www.hcg.com), a leading clinical trial recruitment and retention firm. Email her at cgonzalez@hcg.com or follow her at Twitter: @crgonzalez.