HypertensionBEM-IMCNCT04324723
Behaviorally Enhanced Messages to Increase Medical Check-ups(BEM-IMC)
A study testing WhatsApp message in people with Hypertension, run by Kelly Ann Schmidtke at 1 site in Lebanon.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- WhatsApp message
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 1 siteLebanon
- Study dates
- 7 Nov 2018to 10 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- n/a
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- WhatsApp message
- Keywords
- Health Seeking Behaviour, Opportunistic Screening, Randomised Controlled Trial
- Medical subject headings
- Hypertension, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WhatsApp messageBehavioural
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"
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants in this group received a WhatsApp message reminding them to seek further medical attention for their measurement indicated hypertensive condition. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Response taken 56 days after the opportunistic screening (1 = Yes-sought further medical attention, 0 = No)
Secondary outcomes (5)
Self-reported Hypertension
Whether participant says in a pre-intervention survey that they are experiencing hypertension
Measured: 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
Measured: 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.
Measured: A survey response taken at the opportunistic screening.(1 = Yes-experiencing high cholesterol, 0 = No)
Systolic blood pressure (SBP)
Objectively measured at screening event
Measured: 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
Measured: An objective measure taken at the opportunistic screening using an Omron 5 Series BP742N blood pressure monitor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start7 Nov 2018
- Primary completion10 Jan 2019
- Study completion10 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kelly Ann Schmidtke
- Sponsor type
- University, hospital or other
- Collaborators
- B4Development Foundation (Supreme Committee for Delivery and Legacy), Nudge Lebanon, University of Warwick
- Responsible party
- Sponsor-investigator, Kelly Ann Schmidtke, University of Warwick
- Investigators
- Fadi Makki, PhD, Principal investigator, B4Development Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04324723
- Sponsor's protocol ID
- 1
- Acronym
- BEM-IMC
- Status last verified
- Mar 2020
- First submitted
- 23 Mar 2020
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behaviorally Enhanced Messages to Increase Medical Check-ups
- ClinicalTrials.gov ID
- NCT04324723
- Acronym / sponsor ID
- BEM-IMC / 1
- Conditions
- Hypertension
- Keywords
- Health Seeking Behaviour, Opportunistic Screening, Randomised Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Kelly Ann SchmidtkeUniversity, hospital or other
- Collaborators
- B4Development Foundation (Supreme Committee for Delivery and Legacy), Nudge Lebanon, University of Warwick
- Study start
- 7 Nov 2018 (actual)
- Primary completion
- 10 Jan 2019 (actual)
- Study completion
- 10 Jan 2019 (actual)
- First posted
- 27 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: WhatsApp messageParticipants in this group received a WhatsApp message reminding them to seek further medical attention for their measurement indicated hypertensive condition. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- n/a
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WhatsApp messageThe 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" | Behavioural | Intervention |
Primary outcome
Self-reported seeking of further medical attention.
Time frame: Response taken 56 days after the opportunistic screening (1 = Yes-sought further medical attention, 0 = No)
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.
5 secondary outcomes
Self-reported Hypertension
Time frame: A survey response taken at the opportunistic screening.(1 = Yes-experiencing hypertension, 0 = No)
Self-reported Diabetes
Time frame: A survey response taken at the opportunistic screening.(1 = Yes-experiencing diabetes, 0 = No)
Self-reported High Cholesterol
Time frame: A survey response taken at the opportunistic screening.(1 = Yes-experiencing high cholesterol, 0 = No)
Systolic blood pressure (SBP)
Time frame: An objective measure taken at the opportunistic screening using an Omron 5 Series BP742N blood pressure monitor
Diastolic blood pressure (DBP)
Time frame: An objective measure taken at the opportunistic screening using an Omron 5 Series BP742N blood pressure monitor
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2020.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fadi Makki, PhD principal investigator
B4Development Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WhatsApp message in people with Hypertension, run by Kelly Ann Schmidtke at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported seeking of further medical attention. (time frame: Response taken 56 days after the opportunistic screening (1 = Yes-sought further medical attention, 0 = No)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2020.