Clinical trial NCT04324723: Behaviorally Enhanced Messages to Increase Medical Check-ups(BEM-IMC)
Official title: Behaviorally Enhanced Messages to Increase Medical Check-ups
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Health Seeking Behaviour
Opportunistic Screening
Randomised Controlled Trial
Lead sponsor: University of Warwick
Sponsor class: OTHER
Collaborators: name: B4Development Foundation (Supreme Committee for Delivery and Legacy)
name: Nudge Lebanon
name: University of Warwick
First posted: 2020-03-27
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Self-reported seeking of further medical attention.
timeFrame: Response taken 56 days after the opportunistic screening (1 = Yes-sought further medical attention, 0 = No)
Secondary outcomes:
measure: Self-reported Hypertension
timeFrame: A survey response taken at the opportunistic screening.(1 = Yes-experiencing hypertension, 0 = No)
measure: Self-reported Diabetes
timeFrame: A survey response taken at the opportunistic screening.(1 = Yes-experiencing diabetes, 0 = No)
measure: Self-reported High Cholesterol
timeFrame: A survey response taken at the opportunistic screening.(1 = Yes-experiencing high cholesterol, 0 = No)
measure: Systolic blood pressure (SBP)
timeFrame: An objective measure taken at the opportunistic screening using an Omron 5 Series BP742N blood pressure monitor
measure: Diastolic blood pressure (DBP)
timeFrame: An objective measure taken at the opportunistic screening using an Omron 5 Series BP742N blood pressure monitor
Other outcomes:
measure: Heart rate
timeFrame: An objective measure taken at the opportunistic screening using an Omron 5 Series BP742N blood pressure monitor
measure: year of birth
timeFrame: A survey response taken at the opportunistic screening.
measure: Height in cm
timeFrame: A survey response taken at the opportunistic screening.
measure: Weight in kg
timeFrame: A survey response taken at the opportunistic screening.
measure: Known family history of hypertension
timeFrame: A survey response taken at the opportunistic screening.
measure: Know that high blood pressure could cause health problems
timeFrame: A survey response taken at the opportunistic screening.
measure: 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
timeFrame: A survey response taken at the opportunistic screening.
measure: Self-reported blood pressure checking
timeFrame: A survey response taken at the opportunistic screening. (1 = Yes-blood pressure checking, 0 = No)
measure: Self-reported cholesterol checking
timeFrame: A survey response taken at the opportunistic screening. (1 = Yes-cholesterol checking, 0 = No)
measure: Self-reported diabetes checking
timeFrame: A survey response taken at the opportunistic screening.(1 = Yes-diabetes checking, 0 = No)
measure: Self-reported attends regular physical check-ups
timeFrame: A survey response taken at the opportunistic screening.(1 = Yes-attends regular checkups, 0 = No)
measure: Self-reported uses alcohol
timeFrame: A survey response taken at the opportunistic screening.(1 = Yes-consumes alcohol, 0 = No)
measure: Self-reported smoking
timeFrame: A survey response taken at the opportunistic screening.(1 = Yes-smokes, 0 = No)
Locations:
city: Beirut
country: Lebanon
facility: Nudge Lebanon. 3rd Floor, GS Building, Sit Nasab Street
Study officials:
affiliation: B4Development Foundation
name: Fadi Makki, PhD
role: PRINCIPAL_INVESTIGATOR
References: