Behaviorally Enhanced Messages to Increase Medical Check-ups(BEM-IMC)

Study Overview
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Brief Summary
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The study had two stages. Stage 1 involved an opportunistic screening for hypertension conducted at the 2018 Beirut Marathon. During stage 1, participants whose measurements indicated hypertension were invited to take part in a RCT (randomized controlled trial). Stage 2 involved a RCT to evaluate the effectiveness of a behavioural intervention to increase the proportion of participants who sought further medical attention. The research team hypothesised that the intervention would increase the proportion of participants who sought further medical attention compared to a control group that did not receive the intervention. This is a retrospective registration specifically focused on the RCT component of this study. The study was conducted by Nudge Lebanon in partnership with B4- development (formerly known as QBIU) and SmartScience. The RCT was not pre-registered because the collaborators were unaware that pre-registration would be necessary. The collaborators asked the University of Warwick to re-analyse and write the project up for publication after the study was complete. The University of Warwick is now seeking to retrospectively register the trial before submitting to an academic journal. The fact that this trial is retrospectively registered will be plainly stated in the manuscript and all analyses will be presented as exploratory.

Detailed Description
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This study had two stages. Stage 1 involved an opportunistic screening and Stage 2 involved in RCT. This registration focuses on the RCT but both stages are described here. Stage 1. The opportunistic screening for hypertension was conducted around the 2018 Beirut Marathon. Screening tents were set up at the marathon village during the four days leading up to the marathon (7-10 November), where runners collected necessary materials for the run and could take up the screening. An additional two tents were set up during the marathon day were spectators could take part. Participants indicated their consent for the screening before taking part. During their participation they completed surveys about their demographics and health information (including whether they were hypertensive). After they completed the survey, nurses and trained team members measured their blood pressure using calibrated equipment. Those participants whose measurements indicated hypertension were invited to participate in the RCT. Stage 2. For the RCT participants were randomly assigned to either a intervention or control group in a 1:1 fashion. Participants in the intervention group were sent a WhatsApp message 25 days after the marathon reminding them to seek help for their hypertensive condition. Participants in the control group were not sent this message. Then one month later the researchers called all these participants to ask wither they sought further medical attention. The main outcome was whether participants self-reported seeking further medical attention. The research objectives were as follows: Stage 1 screening: Evaluate if the opportunistic screening increased people's awareness of their hypertensive condition. Stage 2 RCT: Evaluate if the intervention increased the proportion of participants who sought further medical attention.

Official Title
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Behaviorally Enhanced Messages to Increase Medical Check-ups

Conditions
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Hypertension

Intervention / Treatment
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* Behavioral: WhatsApp message


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: objectively taken measurements at opportunistic screening indicated hypertension, provided informed consented to participate in the trial, and provided valid contact details for a smart phone with WhatsApp messenger Exclusion Criteria: n/a

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Participants in this group received a WhatsApp message reminding them to seek further medical attention for their measurement indicated hypertensive condition. | Behavioral: WhatsApp message<br>* The experimentally evaluated part of the intervention is a WhatsApp message. The message translated from Arabic to English appears below. Dear [First name], Your BP reading during Beirut Marathon was [reading]. This indicates that you have elevated blood pressure. You should seek medical attention at your earliest convenience. Your wellbeing matters to us. Nudge Lebanon team<br>|
| No Intervention: Control<br>Participants in this group did not received a WhatsApp message reminding them to seek further medical attention for their measurement indicated hypertensive condition. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported seeking of further medical attention. | If participants tell the researcher that they sought further medical attention via a phone call they received approximately 1 month after the WhatsApp messages were sent to participants. | Response taken 56 days after the opportunistic screening (1 = Yes-sought further medical attention, 0 = No) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported Hypertension | Whether participant says in a pre-intervention survey that they are experiencing hypertension | A survey response taken at the opportunistic screening.(1 = Yes-experiencing hypertension, 0 = No) | 
| Self-reported Diabetes | Whether participant says in a pre-intervention survey that they are experiencing diabetes | A survey response taken at the opportunistic screening.(1 = Yes-experiencing diabetes, 0 = No) | 
| Self-reported High Cholesterol | Whether participant says in a pre-intervention survey that they are experiencing high cholesterol. | A survey response taken at the opportunistic screening.(1 = Yes-experiencing high cholesterol, 0 = No) | 
| Systolic blood pressure (SBP) | Objectively measured at screening event | An objective measure taken at the opportunistic screening using an Omron 5 Series BP742N blood pressure monitor | 
| Diastolic blood pressure (DBP) | Objectively measured at screening event | An objective measure taken at the opportunistic screening using an Omron 5 Series BP742N blood pressure monitor | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Health Seeking Behaviour, Opportunistic Screening, Randomised Controlled Trial