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

Behaviorally Enhanced Messages to Increase Medical Check-ups

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: WhatsApp message

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 266
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon
    • Nudge Lebanon. 3rd Floor, GS Building, Sit Nasab Street

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention; Participants in this group received a WhatsApp message reminding them to seek further medical attention for their measurement indicated hypertensive condition.	Behavioral: WhatsApp message; 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"
NO_INTERVENTION: Control; 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?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Objectively measured at screening event	An objective measure taken at the opportunistic screening using an Omron 5 Series BP742N blood pressure monitor
year of birth	Year indicated in pre-intervention survey	A survey response taken at the opportunistic screening.
Height in cm	Height indicated in pre-intervention survey	A survey response taken at the opportunistic screening.
Weight in kg	Weight indicated in pre-intervention survey	A survey response taken at the opportunistic screening.
Known family history of hypertension	Knowledge of family history indicated in pre-intervention survey	A survey response taken at the opportunistic screening.
Know that high blood pressure could cause health problems	Knowledge of blood pressure health problems indicated in pre-intervention survey	A survey response taken at the opportunistic screening.
knew that SBP measures over 140 mm Hg and DBP measures over 90mmHg (millimeters of mercury) were the diagnostic thresholds for stage II hypertension that may require treatment	Knowledge of diagnostic thresholds indicated in pre-intervention survey	A survey response taken at the opportunistic screening.
Self-reported blood pressure checking	Self-reported blood pressure checking	A survey response taken at the opportunistic screening. (1 = Yes-blood pressure checking, 0 = No)
Self-reported cholesterol checking	Self-reported cholesterol checking	A survey response taken at the opportunistic screening. (1 = Yes-cholesterol checking, 0 = No)
Self-reported diabetes checking	Self-reported diabetes checking	A survey response taken at the opportunistic screening.(1 = Yes-diabetes checking, 0 = No)
Self-reported attends regular physical check-ups	Self-reported attends regular physical check-ups	A survey response taken at the opportunistic screening.(1 = Yes-attends regular checkups, 0 = No)
Self-reported uses alcohol	Self-reported uses alcohol	A survey response taken at the opportunistic screening.(1 = Yes-consumes alcohol, 0 = No)
Self-reported smoking	Self-reported smoking	A survey response taken at the opportunistic screening.(1 = Yes-smokes, 0 = No)

Collaborators and Investigators

• Sponsor: Kelly Ann Schmidtke
• Collaborators: University of Warwick; B4Development Foundation (Supreme Committee for Delivery and Legacy); Nudge Lebanon
• Investigators: Principal Investigator: Fadi Makki, PhD, B4Development Foundation

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 7, 2018
• Primary Completion (ACTUAL): January 10, 2019
• Study Completion (ACTUAL): January 10, 2019

Study Registration Dates

• First Submitted: March 23, 2020
• First Submitted That Met QC Criteria: March 25, 2020
• First Posted (ACTUAL): March 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 27, 2020
• Last Update Submitted That Met QC Criteria: March 25, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Randomised Controlled Trial; Opportunistic Screening; Health Seeking Behaviour
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 1 (Other Identifier: Mobile Health and Wellness Program)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

The research team will cannot make identifiable individual participant data available.

The de-identified participant data used in this papers analyses can be made available by contacting Kelly Ann Schmidtke (ORCID identifier: 0000-0001-5993-0358) and can be reused for further analyses.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No