GIRAF Study Achieves 97.5% Weekly Compliance and 84% Blood Sample Completion Using uMotif eCOA Platform

Study Summary

uMotif’s eCOA Platform, combined with dried blood spot sampling (DBSS), powered Gaining Insight into RheumAtic Fatigue (GIRAF), a fully remote study led by the University of Manchester to explore the link between rheumatic and musculoskeletal disease (RMD)-fatigue and inflammation. Over 30 days, participants completed twice-daily symptom assessments via the uMotif app and provided at-home blood samples by mail — achieving rapid study launch, high engagement, and high-quality data.

At-a-glance metrics

Launched in eight weeks, from concept to data capture
97.5% completed data on average weekly
85% provided data on five or more days per week
84% completion of DBSS — far higher than expected

Situation: Understanding the link between RMD-fatigue and inflammation

Approximately 75% of patients with RMDs, such as rheumatoid arthritis, fibromyalgia, and osteoarthritis, experience fatigue, which can be unpredictable and impact daily activities.

While the causes of RMD-fatigue remain unclear, inflammation — either directly or indirectly related to other co-morbidities, such as pain and mood — has long been suspected as playing a role.

Researchers at the University of Manchester launched the GIRAF study in 2019 to better understand connections between RMD-fatigue and inflammation. This first-of-its-kind study featured fully remote data collection using uMotif’s eCOA platform and DBSS.

Challenge: Timely, accurate, and convenient data and blood sample collection

Understanding the relationship between inflammation, RMD symptoms, and fatigue requires frequent blood sampling as well as detailed and prompt symptom assessments. Lab-conducted blood draws, however, significantly increase the time and engagement burden on study participants who must travel to collection sites. This limits the frequency of sample collection and prevents the opportunity for daily sampling. The need to record and report symptoms throughout the day using traditional logs also elevates participant requirements significantly.

To ease these burdens, the research team wanted to use a fully remote data and blood collection model. To do this, it needed a user-friendly platform to collect serial assessments of symptoms at various times of day over an extended period, and a more convenient and effective way to collect blood samples.

The team found a highly effective solution, combining DBSS technology with uMotif’s eCOA platform, which puts patients at the center of clinical research to improve the participant experience and reliability of patient-reported data.

What the eCOA platform needed to deliver

Serial, multi-time-of-day symptom assessments over an extended period
A convenient way for patients to collect and return their own blood samples
An engaging enough experience to sustain the reliability of patient-reported data

“We wanted to look at daily changes, so we needed to capture daily symptom assessments, along with data from blood collection. The uMotif app, with its robust functionality, enabled us to efficiently capture and record daily symptom data, while supporting engagement that elevated DBSS compliance.”

Katie Druce, Research Fellow and Patient and Public Engagement Lead at the Centre for Epidemiology Versus Arthritis

Solution: A patient-centric, GDPR-compliant eCOA platform

uMotif provided an easy-to-use and patient-centric tool to boost engagement and data accuracy; was secure and compliant with GDPR (a consumer data protection law in the EU) and other requirements; and could support a rapid launch with flexible and highly configurable modules.

In addition, members of the research team had used the uMotif eCOA platform in previous studies and had achieved high engagement — between 89%–91% — across a period of up to six months.

Why uMotif

Patient-centric design proven to boost engagement and data accuracy
Secure and GDPR-compliant
Flexible, highly configurable modules that supported a rapid launch
A track record of 89%–91% engagement in prior studies over up to six months

How it worked: Twice-daily symptom tracking on the eCOA platform paired with at-home blood sampling

Over 30 days, participants completed daily symptom monitoring using uMotif’s smartphone/tablet app, designed in collaboration with patients to ensure an optimal user experience. They received prompts twice daily to complete 10 symptom ratings, including fatigue severity, mood, and coping, on a 1–5 scale.

The study also included real-time data monitoring and targeted completion reminders if a participant had not reported for three or more days. Patients completed DBSS on days 1–7, 14, and 30 and mailed the completed tests back to the research team. C-reactive protein (CRP) values — an inflammation marker — were extracted from the tests. To boost DBSS participation, patients received reminders via the uMotif smartphone app.

Data and assessments collected

Fatigue severity (twice daily, 1–5 scale)
Mood and coping (twice daily, 1–5 scale)
10 total symptom ratings captured per prompt
DBSS on days 1–7, 14, and 30
CRP levels extracted from blood samples

Results and Impact: High engagement, accurate data, and research innovation with uMotif’s eCOA platform

Together, uMotif’s eCOA Platform and DBSS provided a valuable model for capturing the symptom assessments and biological samples necessary to gain insight into previously unanswerable questions about RMD-related fatigue.

Key metrics

Symptom reporting:

97.5% completed data on average weekly
85% provided data on five or more days per week

DBSS participation:

84% completion of DBSS, far higher than expected
Full viability of samples returned to the study team
High completion rates were seen across all disease groups (rheumatoid arthritis, osteoarthritis, and fibromyalgia)

Rapid launch, efficient data collection:

Launched in eight weeks, from concept to data capture
Recruited participants in two weeks, including onboarding to uMotif
Benefited from a highly efficient data collection model

Lessons Learned: What the results mean for researchers

Frequent, app-based symptom prompts can sustain very high compliance even over a demanding twice-daily schedule, while DBSS shows strong promise as a feasible, patient-friendly alternative to lab-based blood draws in remote rheumatology research. Together, this model shows how decentralized data and biosample collection can unlock research questions that traditional, clinic-based approaches could not easily answer.

FAQs

What is the GIRAF study?

A fully remote study led by the University of Manchester, launched in 2019, that used uMotif’s eCOA platform and DBSS to explore the link between RMD-fatigue and inflammation.

How did participants take part?

Over 30 days, participants completed twice-daily symptom ratings on the uMotif app and collected their own blood samples on days 1–7, 14, and 30, mailing them back to the research team.

What data was collected?

Ten symptom ratings per prompt — including fatigue severity, mood, and coping — captured twice daily, plus DBSS analyzed for CRP, an inflammation marker.

What were the outcomes?

97.5% of participants completed data on average weekly, 84% completed their dried blood spot samples, and the study launched in just eight weeks — demo

Explore Related uMotif Resources

uMotif’s eCOA Platform — an overview of uMotif’s configurable eCOA platform.
The Benefits of eCOA — why electronic clinical outcome assessment improves data quality and compliance.
Decentralizing Clinical Trials — how sponsors can move data capture out of the clinic without compromising quality.
More uMotif Case Studies — see how the platform performs across other therapeutic areas.

Next Steps

Find out more about how uMotif can help drive unparalleled patient engagement and data capture in your next study.

Key Terms Explained

A few specialist terms used throughout this case study, defined for readers new to clinical trial technology:

eCOA: Electronic Clinical Outcome Assessment — any clinical outcome data (symptoms, function, quality of life) captured electronically instead of on paper.

ePRO: Electronic Patient-Reported Outcome — a type of eCOA completed directly by the patient, typically via an app or web form, rather than a clinician.

DBSS: Dried Blood Spot Sampling — a method of collecting a small blood sample at home, which is dried and mailed to a lab for analysis, removing the need for an in-clinic blood draw.

RMD: Rheumatic and Musculoskeletal Disease — a category of conditions that includes rheumatoid arthritis, fibromyalgia, and osteoarthritis.

CRP: C-Reactive Protein — a blood marker used to measure levels of inflammation in the body.

GDPR: General Data Protection Regulation — the EU’s data privacy and security law.