Home readings are only useful in a trial when every participant measures the same way and records the context. This template turns the usual paper log into a short phone diary: two seated readings a minute apart, morning and evening, with rest, arm, time and dose timing recorded every session.
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Home blood pressure · Morning
Subject 003-0017 · Day 4 of 7 · Demo study
Sat quietly for 5 minutes first?
Arm used
Time of first reading
Reading 1 systolic / diastolic
Reading 2 systolic / diastolic
Pulse (reading 2)
Taken your blood pressure tablet yet today?
At a glance
Why a structured log
A paper log looks simple: a date, a time and two numbers. In practice it collects the wrong thing. Participants write down one reading instead of two, round to the nearest 5, skip the evening session, measure right after climbing the stairs, or fill in a week of readings in the waiting room before the visit. None of that is visible on the sheet, so the average that reaches the analysis carries errors nobody can quantify.
Antihypertensive trials, cardiovascular safety studies and studies of drugs with a blood pressure signal increasingly use home readings next to office measurements. Home values avoid the white-coat effect, give many more readings per participant and show the trough effect of a once-daily drug when the morning reading is taken before the dose. That only works if each session is structured: when it happened, how it was done and what was measured.
A phone diary fixes most of this. Each session is a separate entry with its own timestamp in the audit trail, the two readings are separate fields, and the questions about rest and arm are asked every time rather than once at training. Office readings stay on the site's vital signs eCRF, where calculated MAP and pulse pressure and range checks apply, so you can compare home and office values per participant.
The 2025 AHA/ACC guideline for high blood pressure in adults (published in Hypertension and Circulation, August 2025) recommends home monitoring with a validated upper-arm device. The 2023 ESH guidelines (Journal of Hypertension) put weight on clinically validated devices, and ESH guidance uses 135/85 mmHg as the home threshold. A 2022 review in the Journal of Clinical Hypertension (Kario and colleagues) describes the 7-day, twice-daily, duplicate-reading "722" protocol used by most studies. Quote the version your protocol follows; this page is not clinical advice.
Template
One entry per session. Morning and evening use the same form, so the dataset has the same columns for every reading.
| Field | Question type | Values or unit | Why it is there |
|---|---|---|---|
| Session | Single choice | Morning, evening | Analyses often treat morning and evening separately |
| Rested seated for 5 minutes | Single choice | Yes, no | Flags readings taken without rest |
| Caffeine, exercise or smoking in the last 30 minutes | Single choice | Yes, no | Common reason for a high single reading |
| Arm used | Single choice | Left, right | The protocol usually fixes the arm with the higher office reading |
| Time of first reading | Time | hh:mm | Shows whether the session fell in the protocol window |
| Reading 1 systolic | Numeric | mmHg, whole number | Kept separate so the average is computed, not estimated |
| Reading 1 diastolic | Numeric | mmHg, whole number | As above |
| Reading 2 systolic and diastolic | Numeric | mmHg | Second reading 1 minute later |
| Pulse | Numeric | beats per minute | Most cuffs display it; useful for drugs with a heart rate effect |
| Morning dose already taken | Single choice | Not yet, already taken | Separates trough from post-dose readings |
| Anything unusual | Long text (optional) | Free text | Cuff error, felt unwell, symptoms |
Two numeric fields per reading (systolic and diastolic) keep exports clean. The phone mock-up above combines them for display only.
Timing
Most trials do not ask for home readings every day for months. They ask for a block of about 7 days before each decision point: screening or run-in, baseline and each efficacy visit. The schedule below is a common pattern. A run-in block also trains participants and shows who can keep the routine before randomisation.
Set two daily tasks during each block, one for the morning session and one for the evening. A morning window that closes before most people take their tablets keeps trough readings clean. Completion windows stop participants entering a week of readings from memory, and the reminder ladder sends up to three reminders per task (when due, the next day and a final notice before the window closes), respects quiet hours in the participant's time zone and stops once the entry is done. The ePRO compliance reminders page describes these controls.
| Assessment | Scr | Run-in | BL | W4 | W8 | W12 |
|---|---|---|---|---|---|---|
| Office BP (vital signs eCRF) | ||||||
| Cuff check against office reading | ||||||
| Home BP, morning session | D | D | D | D | D | |
| Home BP, evening session | D | D | D | D | D | |
| Site review of diary completeness |
D = 7-day diary block before the visit, two sessions a day
Build the form from the field table, set the morning and evening tasks and walk through a week of entries in the free sandbox.
Data quality
Participant diaries and site eCRFs are checked differently. On site forms, edit checks raise an auto-query when a value breaks a range rule, and the site answers it. A participant cannot answer a query, so diary quality comes from the form design: validation rules on the numeric fields stop an impossible entry such as 1380 at the moment it is typed, required fields stop half-finished sessions, and the completion window decides what a late entry means.
Write the analysis rules into the protocol before the first reading: how many sessions make a valid block (for example at least 12 of 14), whether the first day is dropped, how a session with one reading is handled, and what happens to readings marked as taken without rest. Because each reading is its own field, the statistician applies those rules once, in code, from the export and its data dictionary.
A diary is not a monitoring service. Capture records what participants enter and shows compliance to the team; it does not turn a diary value into a clinical alert. Put the instruction in the form's help text (for example, what to do if a reading is above a protocol threshold), give participants the site phone number, and have the site review diary data at a set frequency. Symptomatic hypotension or a hypertensive event goes on the adverse event eCRF.
Supply or approve one upper-arm cuff model that appears on a validation list such as ValidateBP (US) or STRIDE BP (international), fit the cuff size at screening and record the model and cuff size on a site form. Wrist and finger devices are a poor fit for trial data.
Adapt it
State rest time, readings per session, interval, arm and session times in the protocol, and copy the same wording into the help text.
Pick which visits get a 7-day block, and whether the run-in block counts toward eligibility.
Add the fields from the table using numeric, single choice, time and long text questions, or upload the table and let the AI form builder draft it for your review.
One morning task and one evening task per day of the block, with completion windows that match your trough definition.
Office readings, cuff model and cuff size go on site eCRFs, so home and office values sit in one participant record.
Session (morning or evening), rest before measuring, arm, time, each reading's systolic and diastolic values as separate fields, pulse, whether the morning dose was already taken and an optional comment.
Most guidelines describe two readings 1 minute apart, morning and evening, for up to 7 days before a decision point. Your protocol sets the exact routine.
Not in this template. The participant types each value from the cuff display into the diary on their phone, and every entry is time-stamped in the audit trail.
No. Each reading is stored separately and the average is derived in analysis from the export, using rules written in the protocol. Office MAP and pulse pressure can be calculated on the site vital signs form.
ESH uses a home average of 135/85 mmHg; the AHA/ACC guideline uses 130/80 mmHg. Use the threshold your protocol and its guideline reference specify.
Yes. It is a generic diary, not a licensed instrument. Build it in the free sandbox with no credit card and pay only when you go live. Validated questionnaires you add alongside it may need their own licences.
Keep exploring
Paired readings, timing and context in one phone diary next to your site data. Free sandbox, no credit card, pay only when live.