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

NCT ID: NCT04324723

Last Updated: 2020-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

266 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-07

Study Completion Date

2019-01-10

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.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors
The researchers who called participants to ask if they sought further medical attention was not made aware of the participants' conditions.

Study Groups

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Intervention

Participants in this group received a WhatsApp message reminding them to seek further medical attention for their measurement indicated hypertensive condition.

Group Type EXPERIMENTAL

WhatsApp message

Intervention Type BEHAVIORAL

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"

Control

Participants in this group did not received a WhatsApp message reminding them to seek further medical attention for their measurement indicated hypertensive condition.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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"

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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B4Development Foundation (Supreme Committee for Delivery and Legacy)

UNKNOWN

Sponsor Role collaborator

Nudge Lebanon

UNKNOWN

Sponsor Role collaborator

University of Warwick

OTHER

Sponsor Role collaborator

Kelly Ann Schmidtke

OTHER

Sponsor Role lead

Responsible Party

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Kelly Ann Schmidtke

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Fadi Makki, PhD

Role: PRINCIPAL_INVESTIGATOR

B4Development Foundation

Locations

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

Beirut, , Lebanon

Site Status

Countries

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Lebanon

Other Identifiers

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1

Identifier Type: -

Identifier Source: org_study_id

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