Case Study 4 minute read

Virtual Trials Yields High Patient Compliance with Datacubed



Clinical research studies involving repeated patient-reported outcome measures (PROs) face several challenges. Patients may fail to complete individual PROs, whether at all or within a specified time (i.e., reduced compliance). Patients may cease participating in a study altogether, dropping out before all study procedures are completed (i.e., reduced retention). Sponsors must consider strategies to maximize participant retention and compliance to avoid loss of PRO data relevant to study endpoints. And to avoid financial and operational burdens associated with participant loss to follow-up.

Through Datacubed Health’s Linkt app, participants can easily complete PROs via their smartphones. Several features are available within Linkt to assist study staff with ensuring high participant retention and compliance, including configurable reminders to complete instruments. Moreover, Linkt leverages behavioral science to sustain high compliance and retention rates, with several tiered motivational elements for short, medium, and long-term studies.


Accordingly, a study was conducted by a large academic medical center in New York City. The study enrolled 124 participants located across the United States. Participants downloaded the Linkt app onto their personal smartphone devices. Through Linkt, participants completed a daily diary and other electronic patient reported outcome (ePROs) for 55 days. At least one instrument was deployed each day. Throughout the course of the complete study subjects were asked to complete a total of 104 instruments.

Participants ranged from 18-64 years of age at time of enrollment. Participants were 59.35% female and 40.65% male. Also, a language other than English was spoken at home by 50% of the participants, although the researchers delivered all instruments for this study in American English. The majority of participants held a college degree, worked full-time, and used an iPhone to participate in the study (See Table 1).


Overall, the study retained 93.5% of participants (N=116) for the entire 55-day duration (Figure 2).In this study, all fully retained participants had a compliance rate of 100% (Figure 3). Eight participants withdrew from the study early. The average participant who withdrew from the study did so after 23 days. Or after completing approximately 50% of the study. A strong correlation between time-to-withdrawal and compliance rate (R=0.98) indicated that participants who remained in the study longer demonstrated higher compliance (Figure 4). There were no effects of demographic variables (e.g., age, gender, education, employment status, etc.) on overall retention (Table 2).

We defined compliance as a proportion. The number of completed instruments as a percentage of the number of instruments delivered in the Linkt App. When considering all participants (both retained and lost), the average compliance rate for study measures completed via Linkt was 96.2%. The overwhelming majority of participants (N=116; 93.5% of participants) had a perfect compliance rate of 100% (Figure 3). For the 8 participants who withdrew early and did not complete all the study instruments, compliance ranged from 18.9%-78.4%. There were no effects of demographic variables (e.g., age, gender, education, employment status, etc.) on overall compliance (Table 2).

study retention data
clinical trial compliance data


In conclusion, the majority of participants in the present study were 100% compliant. And retained through study end, completing a minimum of one instrument per day, or 104 instruments total, for 55 days. Deploying daily diary and ePRO measures via Linkt results in high retention and average compliance rates (93.5% and 96.2%, respectively). And can even achieve 100% compliance amongst the retained cohort. As a result, participants of diverse demographic backgrounds (e.g., age, sex, race, socioeconomic status, language) well tolerated Linkt. When deployed with standard engagement and gamification features, studies using the Linkt platform can expect to achieve high retention and compliance rates, across diverse participant populations.

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