Road Traffic Injury PreventionNCT02120742
The Impact Of Text Message (SMS) Reminders On Helmet Use Among Motorcycle Drivers In Dar Es Salaam, Tanzania
A study testing SMS message reminder in people with Road Traffic Injury Prevention and Helmet Use, run by Amend at 1 site in Tanzania.
Trial summary
This study seeks to evaluate the impact of a text-message (SMS) program delivered to motorcycle drivers in Dar es Salaam, Tanzania. The SMS program, delivered by nonprofit Amend, sends daily reminders to motorcycle drivers to remind them to wear their helmets. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Road Traffic Injury Prevention, Helmet Use, mHealth Intervention
- What is being tested?
- SMS message reminder
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 391 participants
- Where
- 1 siteTanzania
- Study dates
- Apr 2014to Sep 2015
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Must own a cell phone with text-message features
- Must demonstrate ability to retrieve and read text-messages
- Must have access to a helmet.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Tanzania1 site
Muhimbili University of Health and Allied Sciences
Dar es Salaam, Upanga West, 65001
About this study
This study seeks to evaluate the impact of a text-message (SMS) program delivered to motorcycle drivers in Dar es Salaam, Tanzania. The SMS program, delivered by nonprofit Amend, sends daily reminders to motorcycle drivers to remind them to wear their helmets. In this study, the investigators will conduct a randomized controlled trial to see if this program leads to increased helmet use over time. The investigators will recruit between 350-400 motorcycle drivers to receive the text program. The investigators will obtain each of their cell phone numbers, and the participants will be split into three groups. The first group will receive reminders framed as social norming (ie "Most of your peers wear helmets"). The second group will receive reminders framed as fear appeals (ie "Not wearing your helmet increases your chance of dying in an accident"). The third group will act as the control and receive texts that relate to general road safety, but not helmet use. All groups will receive the same general road safety information being delivered to the control arm. The purpose of sending different types of reminders is to assess which type of messages are more likely to cause a motorcycle driver to regularly wear their helmet. The investigators will survey the participants at the initiation of the study and after weeks 3 and 6 during the study, asking about their helmet use. This will be a short survey, and any personal information gathered during the study (ie, phone numbers), will be securely stored so as to protect their privacy.
- Being tested
- SMS message reminder
- Keywords
- Road traffic injury prevention, Helmet use, mHealth intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS message reminderBehavioural
SMS texts will be delivered to study participants over a 6-week period.
| Study group | Role | What they receive |
|---|---|---|
| Social Norming | Experimental | The first group will receive SMS message reminders framed as social norming (ie "Most of your peers wear helmets"). Receives: Behavioral: SMS message reminder |
| Fear Appeal | Experimental | The second group will receive SMS message reminders framed as fear appeals (ie "Not wearing your helmet increases your chance of dying in an accident"). Receives: Behavioral: SMS message reminder |
| Control | Placebo comparator | The third group will act as the control and receive texts that relate to general road safety, but not helmet use. Receives: Behavioral: SMS message reminder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported adherence to helmet use
The primary outcome of the study will be self-reported adherence to helmet use as measured by the proportion of participants who wear their helmet on all trips
Measured: Midpoint of study (3 weeks)
Self-reported adherence to helmet use
The primary outcome of the study will be self-reported adherence to helmet use as measured by the proportion of participants who wear their helmet on all trips
Measured: Endpoint of study (6 weeks)
Secondary outcomes (1)
Attitude change
A secondary outcome will be participants' attitudes toward helmet use and the SMS reminder platform, as measured by an open-ended survey at the end of the study.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2014
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Road Traffic Injury PreventionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 391 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amend
- Sponsor type
- University, hospital or other
- Collaborators
- Dartmouth-Hitchcock Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02120742
- Sponsor's protocol ID
- D14103
- Status last verified
- Sep 2015
- First submitted
- 19 Apr 2014
- Last updated
- 30 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Campbell B, Heitner J, Amos Mwelelo P, Fogel A, Mujumdar V, Adams LV, Boniface R, Su Y. Impact of SMS Text Messaging Reminders on Helmet Use Among Motorcycle Drivers in Dar es Salaam, Tanzania: Randomized Controlled Trial. J Med Internet Res. 2022 Apr 7;24(4):e27387. doi: 10.2196/27387.
PubMed 35389364
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact Of Text Message (SMS) Reminders On Helmet Use Among Motorcycle Drivers In Dar Es Salaam, Tanzania
- ClinicalTrials.gov ID
- NCT02120742
- Acronym / sponsor ID
- D14103
- Keywords
- Road traffic injury prevention, Helmet use, mHealth intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 391 participants (actual)
- Lead sponsor
- AmendUniversity, hospital or other
- Collaborators
- Dartmouth-Hitchcock Medical Center
- Study start
- Apr 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 23 Apr 2014 (estimated)
- 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.
This study seeks to evaluate the impact of a text-message (SMS) program delivered to motorcycle drivers in Dar es Salaam, Tanzania. The SMS program, delivered by nonprofit Amend, sends daily reminders to motorcycle drivers to remind them to wear their helmets. In this study, the investigators will conduct a randomized controlled trial to see if this program leads to increased helmet use over time. The investigators will recruit between 350-400 motorcycle drivers to receive the text program. The investigators will obtain each of their cell phone numbers, and the participants will be split into three groups. The first group will receive reminders framed as social norming (ie "Most of your peers wear helmets"). The second group will receive reminders framed as fear appeals (ie "Not wearing your helmet increases your chance of dying in an accident"). The third group will act as the control and receive texts that relate to general road safety, but not helmet use. All groups will receive the same general road safety information being delivered to the control arm. The purpose of sending different types of reminders is to assess which type of messages are more likely to cause a motorcycle driver to regularly wear their helmet. The investigators will survey the participants at the initiation of the study and after weeks 3 and 6 during the study, asking about their helmet use. This will be a short survey, and any personal information gathered during the study (ie, phone numbers), will be securely stored so as to protect their privacy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Social Norming | Experimental | Behavioral: SMS message reminderThe first group will receive SMS message reminders framed as social norming (ie "Most of your peers wear helmets"). |
| Fear Appeal | Experimental | Behavioral: SMS message reminderThe second group will receive SMS message reminders framed as fear appeals (ie "Not wearing your helmet increases your chance of dying in an accident"). |
| Control | Placebo comparator | Behavioral: SMS message reminderThe third group will act as the control and receive texts that relate to general road safety, but not helmet use. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 or older
- Must own a cell phone with text-message features
- Must demonstrate ability to retrieve and read text-messages
- Must have access to a helmet.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| SMS message reminderSMS texts will be delivered to study participants over a 6-week period. | Behavioural | Control, Fear Appeal, Social Norming |
Primary outcome
Self-reported adherence to helmet use
Time frame: Midpoint of study (3 weeks)
The primary outcome of the study will be self-reported adherence to helmet use as measured by the proportion of participants who wear their helmet on all trips
Self-reported adherence to helmet use
Time frame: Endpoint of study (6 weeks)
The primary outcome of the study will be self-reported adherence to helmet use as measured by the proportion of participants who wear their helmet on all trips
1 secondary outcome
Attitude change
Time frame: 6 weeks
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 30 Sep 2015.
- Derived from this study: PubMed 35389364Campbell B, Heitner J, Amos Mwelelo P, Fogel A, Mujumdar V, Adams LV, Boniface R, Su Y. Impact of SMS Text Messaging Reminders on Helmet Use Among Motorcycle Drivers in Dar es Salaam, Tanzania: Randomized Controlled Trial. J Med Internet Res. 2022 Apr 7;24(4):e27387. doi: 10.2196/27387.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMS message reminder in people with Road Traffic Injury Prevention and Helmet Use, run by Amend at 1 site in Tanzania.
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 4 inclusion and 0 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 30 Sep 2015. 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 Tanzania. 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. Some participants in this study may receive a placebo. 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 adherence to helmet use (time frame: Midpoint of study (3 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02120742, which also lists 1 linked publication.
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 30 Sep 2015.