Digital Health Study Planning

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:

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