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

Hypertension Clinical Trial

— BEM-IMC  

Official title:

Behaviorally Enhanced Messages to Increase Medical Check-ups

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04324723
• Other study ID #: 1
• Status: Completed
• Phase: N/A
• Start date: November 7, 2018
• Est. completion date: January 10, 2019

Study information

• Verified date: March 2020
• Source: University of Warwick
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 266
• Est. completion date: January 10, 2019
• Est. primary completion date: January 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

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"

Locations

Country	Name	City	State
Lebanon	Nudge Lebanon. 3rd Floor, GS Building, Sit Nasab Street	Beirut

Sponsors (4)

Lead Sponsor	Collaborator
Kelly Ann Schmidtke	B4Development Foundation (Supreme Committee for Delivery and Legacy), Nudge Lebanon, University of Warwick

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Heart rate	Objectively measured at screening event	An objective measure taken at the opportunistic screening using an Omron 5 Series BP742N blood pressure monitor
Other	year of birth	Year indicated in pre-intervention survey	A survey response taken at the opportunistic screening.
Other	Height in cm	Height indicated in pre-intervention survey	A survey response taken at the opportunistic screening.
Other	Weight in kg	Weight indicated in pre-intervention survey	A survey response taken at the opportunistic screening.
Other	Known family history of hypertension	Knowledge of family history indicated in pre-intervention survey	A survey response taken at the opportunistic screening.
Other	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.
Other	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.
Other	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)
Other	Self-reported cholesterol checking	Self-reported cholesterol checking	A survey response taken at the opportunistic screening. (1 = Yes-cholesterol checking, 0 = No)
Other	Self-reported diabetes checking	Self-reported diabetes checking	A survey response taken at the opportunistic screening.(1 = Yes-diabetes checking, 0 = No)
Other	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)
Other	Self-reported uses alcohol	Self-reported uses alcohol	A survey response taken at the opportunistic screening.(1 = Yes-consumes alcohol, 0 = No)
Other	Self-reported smoking	Self-reported smoking	A survey response taken at the opportunistic screening.(1 = Yes-smokes, 0 = No)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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