Hypertension Clinical Trial
— *StAROfficial title:
SMS-text Adherence Support (StAR*) Study, a Randomized Three-arm Open Parallel Group Trial to Evaluate the Effects of a Structured Programme of Hypertension Treatment Adherence Support Delivered Remotely Through SMS-text Messages on Blood Pressure at 12 Months as Compared With Usual Care.
General synopsis for SMS-text Adherence Support (*StAR) Study and associated preparatory and
pilot work
Background: High blood pressure is an important risk factor for heart disease, stroke and
chronic kidney disease. Clear evidence exists that for individuals with high blood pressure
(hypertension) lowering blood pressure really reduces this risk. One of the critical factors
in the long term control of blood pressure is the regular use of effective antihypertensive
medications. In South Africa, poor treatment adherence (attending clinic, re-filling
prescriptions, and regularly taking hypertension tablets) is known to be an important and
alterable risk factor for uncontrolled high blood pressure and its complications (heart
disease, stroke and chronic kidney disease). SMS-text messages have been shown to improve
clinic attendance and medication adherence for some diseases (like HIV and TB) in other
low-resource settings. It is not clear whether SMS-text messages to support treatment
adherence have an effect on long-term blood pressure control. The acceptability,
sustainability and scalability such technology also remains to be determined.
Aim: To investigate if a system of SMS-text messages to support treatment adherence is more
effective than usual care for controlling high blood-pressure.
Objectives: The main objective is to test whether advice and support given by SMS-text,
either by providing information (informational) or by allowing a two-way communication
(interactive) improves control of blood pressure at one year compared to usual care.
Additional objectives include assessing whether the interventions have an effect on,
- Clinic attendance
- Prescription refill adherence
- Self-reported medication adherence
- Hypertension related illness or death
- Patient empowerment
Study design: Single centre randomized three-arm parallel group trial As it is not clear how
best to support treatment adherence for people with hypertension we need to compare the
different ways this might be done. Eligible patients who provide written consent will be put
into one of three groups and then compared. The groups are selected by a computer which has
no information about the individual (i.e. by chance). Participants in each group will get
different types of SMS-text messages and these are compared.
Study interventions:
- Enhanced usual care In addition to their usual clinical care participants will receive
the pre-randomisation "Welcome to the *StAR Study" SMS-text, a "Happy Birthday"
SMS-text on their date of birth and up to six additional SMS-text messages containing
study specific information and thanking the participant for taking part in the study.
- Informational SMS-text messages In addition to enhanced usual care, participants
allocated to the informational SMS-text support group will receive semi-tailored
structured adherence-support (including clinic appointment and medication pick-up
reminders, medication adherence support and hypertension-related education.)
- Interactive SMS-text messages In addition to enhanced usual care and informational
SMS-text messages, SMS-text messages sent to participants in the interactive SMS-text
group will contain a "prompt to respond" which will guide participants to additional
SMS-text based resources.
Outcome measures: The main outcome measure is mean blood pressure measured at one year.
Additional outcomes include the proportion of participants with "controlled blood pressure"
as well as measures of clinic attendance, prescription refill adherence, self-reported
medication adherence, hypertension related illness or death, and patient empowerment.
Status | Completed |
Enrollment | 1372 |
Est. completion date | August 2014 |
Est. primary completion date | February 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years and older |
Eligibility |
Inclusion Criteria: - Clinical diagnosis of hypertension and are either currently receiving or are about to start blood pressure lowering medication - Mean blood pressure at enrolment is < 175/105 - Aged 21 years or older - Must have access to a cell-phone (shared access is allowed if access is daily and the phone owner agrees to participate) - Must be able to use SMS-text (help by a partner is allowed for illiterate subjects, subjects with poor vision, or subjects who are learning disabled) - Must be resident in the study area and must be expected to be resident for the duration of the study Exclusion Criteria: - Another member of the household has already been recruited into the trial - If female, they are not pregnant or within three months post-partum by self-report - They are not willing to give informed consent and take part in the study. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Oxford | EPSRC, University of Cape Town, Wellcome Trust |
Bobrow K, Brennan T, Springer D, Levitt NS, Rayner B, Namane M, Yu LM, Tarassenko L, Farmer A. Efficacy of a text messaging (SMS) based intervention for adults with hypertension: protocol for the StAR (SMS Text-message Adherence suppoRt trial) randomised controlled trial. BMC Public Health. 2014 Jan 11;14:28. doi: 10.1186/1471-2458-14-28. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Proportion of participants with a systolic blood pressure < 140 mmHg and a diastolic blood pressure <90 mmHg | At 12-months | No | |
Other | Hospital admissions for hypertension related illnesses | At 12-months | No | |
Other | Self-reported health status | EuroQol 5-Dimension and Visual Analogue Scale | At 12-months | No |
Other | Proportion of scheduled clinic appointments attended | At 12-months | No | |
Other | Satisfaction with clinic services and care | Assessed using 12 5-point Likert-scale items adapted from locally appropriate questionnaires developed to capture patient satisfaction with services. | At 12-months | No |
Other | Self-reported adherence to antihypertensive treatment | At 12-months | No | |
Other | Basic knowledge about hypertension | At 12-months | No | |
Primary | Change in systolic blood pressure | The primary outcome is change in systolic blood pressure which we will analyse using a mixed-effects model on data collected at 6 and 12-months. | 12-months from baseline | No |
Secondary | Measured treatment adherence | Treatment adherence is assessed by calculating the proportion of days covered from routinely collected prescribing and dispensing data obtained during the 12-month follow-up period. | 3-monthly intervals over 12-months of follow-up | No |
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