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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02120742
Other study ID # D14103
Secondary ID
Status Completed
Phase N/A
First received April 19, 2014
Last updated September 28, 2015
Start date April 2014
Est. completion date September 2015

Study information

Verified date September 2015
Source Amend
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardTanzania: Ethical Committee
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 391
Est. completion date September 2015
Est. primary completion date June 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention


Intervention

Behavioral:
SMS message reminder
SMS texts will be delivered to study participants over a 6-week period.

Locations

Country Name City State
Tanzania Muhimbili University of Health and Allied Sciences Dar es Salaam Upanga West

Sponsors (2)

Lead Sponsor Collaborator
Amend Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

Tanzania, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Midpoint of study (3 weeks) No
Primary 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 Endpoint of study (6 weeks) No
Secondary 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. 6 weeks No
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