By John Seaner
The Forgotten Stakeholder:
Why Caregivers Are the Key to Clinical Trial Success And How a PXO Engages Them Right
Every clinical trial has participants.
But many, especially in rare disease, pediatric, oncology, and neurodegenerative trials, also have caregivers making or influencing every major decision along the way.
And yet, most protocols, consent forms, recruitment materials, and retention strategies treat caregivers as afterthoughts:
- No separate communication tracks
- No logistical or emotional support
- No involvement in co-creation of materials
- No metrics to track caregiver burden or confidence
This is a strategic blind spot. Because the caregivers aren’t just companions, they are often the gatekeepers, translators, advocates, schedulers, and navigators of the clinical trial experience.
Jumo Health’s Patient Experience (PX) model doesn’t just include caregivers. It’s built around them.
Understanding the Caregiver’s Role in Clinical Trials
Caregivers wear multiple hats in the clinical trial journey, often simultaneously:
Decision Influencer: Helping a patient evaluate risks, benefits, and feasibility
Logistics Manager: Coordinating appointments, transportation, medicines, and time off work
Emotional Buffer: Managing the psychological toll of participation for both the patient and themselves
Liaison With Site Staff: Communicating questions, concerns, and side effects on the patient’s behalf
Retention Enabler: Ensuring protocol adherence, visit follow-through, and continued engagement
Despite this, trial materials are rarely written for caregivers. Support systems are minimal. Consent forms assume the patient is always the decision-maker.
The result?
- Lower recruitment from family-dependent patient populations
- Higher screen failure when caregivers feel unprepared
- No involvement in co-creation of materials
As a Patient Engagement Organization (PXO), Jumo Health changes this by treating caregivers as primary stakeholders, not supporting characters.
A New PXO Framework for Caregiver Engagement
Jumo Health engages caregivers across 4 integrated layers:
Parallel Education Tracks
Emotional and Logistical Support Tools
Burden Visibility and Mitigation
Caregiver-Centered Outcome Tracking
This framework addresses both the rational and emotional load caregivers carry and builds a support infrastructure that reduces dropout, improves consent quality, and strengthens trial adherence.
1. Parallel Education Tracks
Patients and caregivers process information differently. They have different questions, different fears, and different decision-making roles.
A PXO creates dual communication tracks that include:
Caregiver-specific versions of consent materials, FAQs, visit guides, and trial timelines
Shared decision templates that help caregivers and patients align on priorities
Disease education modules tailored to caregivers’ knowledge gaps
Role framing tools, e.g., “What to expect as a caregiver during this study” videos or infographics
In one pediatric oncology study, PXO-created caregiver education tools led to a 3x improvement in enrollment readiness compared to standard recruitment assets.
2. Emotional and Logistical Support Tools
Caregiving is exhausting. Doing it while managing a clinical trial adds complexity that few sponsors adequately address.
A PXO provides:
Emotional resilience guides: Supporting caregivers in navigating fear, guilt, hope, and fatigue
Time-impact calculators: Visual tools to forecast the weekly and monthly commitment needed
Care coordination planners: Templates for organizing transportation, meals, school, and work coverage
24/7 Q&A systems: Caregiver-specific digital channels (chatbots, hotlines, live chat) for rapid issue resolution
In trials where a PXO deployed caregiver logistics kits, early withdrawal due to “life burden” dropped by 41%.
3. Burden Visibility and Mitigation
You can’t improve what you don’t measure.
A PXO makes caregiver burden visible and actionable using:
Caregiver Burden Index (CBI): A proprietary score tracking time, emotional strain, and logistical effort
Caregiver Confidence Score (CCS): Measures their understanding of the trial and their role
Attrition Risk Forecasting: Identifies when caregiver burnout is likely to lead to dropout
Dynamic feedback loops: Allowing sites to adjust support strategies in real-time
We also work with sponsors to reframe protocol design through a caregiver lens, reducing unnecessary visits, offering virtual options, or providing travel stipends where needed.
4. Caregiver-Centered Outcome Tracking
A PXO ensures caregivers aren’t just engaged, they’re evaluated.
We track:
Caregiver engagement milestones: From consent prep to end-of-trial closure
Satisfaction with site interactions: Using NPS-style tools adapted for caregivers
Perceived trial value: Did they feel it was worth the effort? Would they do it again?
Post-trial activation: Did caregivers become advocates? Did they refer others?
In one rare pediatric neurology trial, caregivers who received PXO support were 2.4x more likely to refer another family to future trials from the same sponsor.
Application by Trial Type
A PXO tailors its caregiver model based on the specific trial population:
- Pediatric Trials: Dual-child and caregiver materials, school coordination kits, developmental appropriateness guides
- Rare Disease: Emphasis on advocacy partnerships, trust-building, and decision fatigue support
- Cognitive Impairment: Enhanced proxy tools, legal and ethical framing modules, multi-generational materials
- Late-Stage Cancer: Hospice care planning tools, end-of-life communication guides, spiritual support integration
Each approach is modular and scalable, allowing sponsors to start small and expand across global protocols.
Caregiver-Centric Design Drives Trial Success
Investing in caregivers isn’t just ethical, it’s operationally strategic.
Trials that support caregivers through a PXO framework see:
Faster enrollment, especially in dependent populations
Better adherence, as caregivers manage routines and side effects
Reduced site burden, since caregivers reduce redundant questions and complaints
Lower screen fail and early dropout, thanks to more confident, prepared families
More equitable participation, including from underserved and non-English-speaking communities
The ROI on caregiver engagement is not theoretical. It shows up in data quality, completion rates, and site performance.
PXO Metrics for Caregiver Engagement
A PXO tracks caregiver outcomes using:
- CBI (Caregiver Burden Index): A multidimensional score of time, energy, and emotional cost
- CCS (Caregiver Confidence Score): How well-prepared and informed they feel
- Engagement Conversion Rate: How many caregivers move from education to trial commitment
- Retention Impact Differential: Comparing retention rates between supported vs. unsupported caregiver cohorts
These metrics give clinical operations executives clear insight into what’s working and where intervention is needed.
Conclusion: The Caregiver Is the Unsung Hero of Clinical Trials
They juggle appointments. They make sacrifices. They do the research. They absorb the stress. And they do it all to support the person they love.
Ignoring caregivers isn’t just a design flaw, it’s a risk to your study’s success.
Jumo Health’s PX model places caregivers at the center of the experience where they’ve always belonged.
Want to reduce dropout, improve consent quality, and expand reach for family-dependent trials? Let’s talk.
