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

NCT04324723 | Completed

• 1 other identifier: 1
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

Health Seeking Behaviour; Opportunistic Screening; Randomised Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Self-reported Hypertension

  A survey response taken at the opportunistic screening.(1 = Yes-experiencing hypertension, 0 = No)

• Self-reported Diabetes

  A survey response taken at the opportunistic screening.(1 = Yes-experiencing diabetes, 0 = No)

• Self-reported High Cholesterol

  A survey response taken at the opportunistic screening.(1 = Yes-experiencing high cholesterol, 0 = No)

• Systolic blood pressure (SBP)

  An objective measure taken at the opportunistic screening using an Omron 5 Series BP742N blood pressure monitor

• Diastolic blood pressure (DBP)

  An objective measure taken at the opportunistic screening using an Omron 5 Series BP742N blood pressure monitor

Other Outcomes (13)

• Heart rate

  An objective measure taken at the opportunistic screening using an Omron 5 Series BP742N blood pressure monitor

• year of birth

  A survey response taken at the opportunistic screening.

• Height in cm

  A survey response taken at the opportunistic screening.

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: WhatsApp message

Control

NO INTERVENTION

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

Interventions

WhatsApp message 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"

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• n/a

Sponsors & Collaborators

• Kelly Ann Schmidtke: lead
• B4Development Foundation (Supreme Committee for Delivery and Legacy): collaborator
• Nudge Lebanon: collaborator
• University of Warwick: collaborator

Study Sites (1)

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

Beirut, Lebanon

Location

MeSH Terms

Conditions

Hypertension; Health Behavior

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Fadi Makki, PhD

  B4Development Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The researchers who called participants to ask if they sought further medical attention was not made aware of the participants' conditions.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: March 27, 2020
• Study Start: November 7, 2018
• Primary Completion: January 10, 2019
• Study Completion: January 10, 2019
• Last Updated: March 27, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)