digital-health-study-planning

Original：🇺🇸 English

Translated

Plan a digital health study or research protocol, including enrollment, consent, data collection, assessment schedules, study operations, and outcome measures.

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Sourcestanfordspezi/spezivibe

Added on2026-03-24

NPX Install

npx skill4agent add stanfordspezi/spezivibe digital-health-study-planning

SKILL.md Content

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Study Planner

Plan digital health studies and research protocols without assuming a particular app stack.

When to Use

Use this skill when you need to:

shape a research question into a study plan
define enrollment, consent, and participation requirements
design data collection and assessment schedules
align outcomes, operations, and participant burden

Working Style

Start by understanding the study, not the interface. Ask questions before proposing structure.

Clarify:

objective or hypothesis
participant population
study type and duration
primary and secondary outcomes
expected study procedures and burden
operational constraints such as staffing, review, and follow-up

Planning Framework

1. Study Overview

Define:

study name
objective or hypothesis
population
study type such as observational, interventional, feasibility, or survey-based
duration and major milestones

2. Enrollment and Consent

Work through:

inclusion criteria
exclusion criteria
recruitment channels
screening steps
consent requirements
participant withdrawal process

Do not assume device ownership, app literacy, or language access without checking.

3. Data Collection Plan

Create a table like this:

Data Type	Source	Frequency	Purpose	Notes
Baseline demographics	Intake questionnaire	Once	Eligibility and cohort description	Keep minimal
Symptoms	Participant self-report	Daily or weekly	Outcome tracking	Define burden clearly
Clinical measurements	Device, sensor, chart, or manual entry	As needed	Primary or secondary outcomes	Clarify validation path
Engagement data	Product telemetry	Ongoing	Feasibility and adherence	Avoid collecting unnecessary detail

4. Assessment Schedule

Map the study rhythm:

baseline
recurring assessments
triggered events
follow-up visits
closeout or exit steps

For each step, note:

what happens
expected completion time
whether it is required or optional
what constitutes missingness or protocol deviation

5. Outcome Measures

Define:

primary outcomes
secondary outcomes
feasibility or engagement measures
timing of analysis
what success or signal detection means

Push for measurable outcomes, not vague aspirations.

Operational Questions

Ask about:

who monitors study progress
who responds to missed assessments
what happens if participants stop engaging
whether reminders, escalations, or coordinator outreach are planned
what data quality review is needed during the study

Deliverable Format

Produce a concise study planning brief with:

study summary
enrollment and consent plan
data collection matrix
assessment schedule
outcome measures
operational risks and open questions

Save the brief as

docs/planning/study-brief.md

in the project repository.

Guardrails

Keep the plan platform-agnostic unless the user explicitly wants implementation advice.
Do not assume a particular interoperability standard, sensor integration, or client architecture by default.
Flag where clinical, statistical, or IRB review is still needed.
Highlight participant burden whenever the plan becomes too heavy.

Checklist

Objective and population clearly defined
Study type and duration captured
Enrollment and consent plan outlined
Data collection matrix created
Assessment schedule defined
Primary and secondary outcomes specified
Operational responsibilities identified
Key risks and open questions documented