NCT02019823

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,372

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable hypertension

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 18, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 24, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

November 11, 2014

Status Verified

November 1, 2014

Enrollment Period

1.7 years

First QC Date

December 18, 2013

Last Update Submit

November 10, 2014

Conditions

HypertensionSMS-textmHealth

Keywords

SMS-textmobile healthmHealthtreatmentadherence

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Measured treatment adherence

    3-monthly intervals over 12-months of follow-up

Other Outcomes (7)

  • Proportion of participants with a systolic blood pressure < 140 mmHg and a diastolic blood pressure <90 mmHg

    At 12-months

  • Hospital admissions for hypertension related illnesses

    At 12-months

  • Self-reported health status

    At 12-months

  • +4 more other outcomes

Study Arms (3)

Enhanced usual care

ACTIVE COMPARATOR

In addition to usual care participants will receive the pre-randomisation "Welcome to the \*StAR Study" SMS-text, post-randomisation they will received 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. Participants in the Enhanced Usual Care group will receive no more than one study specific SMS-text every two months.

Behavioral: Enhanced usual care

Informational SMS-text

EXPERIMENTAL

In addition to enhanced usual care, participants allocated to the informational SMS-text support group will receive a series of text-messages covering the following areas: I. Medication pick-up reminders send 48 hours before scheduled medication pick-up date a) Participants who fail to pick-up medication within 3 days of scheduled pick-up date will be sent one further reminder SMS-text II. III. Clinic appointment reminder 48 hours before scheduled follow-up appointment a) Participants who fail to attend clinic appointment will be sent an additional SMS-text checking they are alright and inviting them to rebook their appointment via the clinic IV. Messages which support medication adherence (focused on organisation, memory, and habit) or provide hypertension related health information

Behavioral: Informational SMS-textBehavioral: Enhanced usual care

Interactive SMS-text

EXPERIMENTAL

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.

Behavioral: Informational SMS-textBehavioral: Interactive SMS-textBehavioral: Enhanced usual care

Interventions

Informational SMS-textBEHAVIORAL
Informational SMS-textInteractive SMS-text
Interactive SMS-textBEHAVIORAL
Interactive SMS-text
Enhanced usual careBEHAVIORAL
Enhanced usual careInformational SMS-textInteractive SMS-text

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 24410738BACKGROUND

  • Bobrow K, Farmer A, Cishe N, Nwagi N, Namane M, Brennan TP, Springer D, Tarassenko L, Levitt N. Using the Medical Research Council framework for development and evaluation of complex interventions in a low resource setting to develop a theory-based treatment support intervention delivered via SMS text message to improve blood pressure control. BMC Health Serv Res. 2018 Jan 23;18(1):33. doi: 10.1186/s12913-017-2808-9.

    PMID: 29361934DERIVED

  • Bobrow K, Farmer AJ, Springer D, Shanyinde M, Yu LM, Brennan T, Rayner B, Namane M, Steyn K, Tarassenko L, Levitt N. Mobile Phone Text Messages to Support Treatment Adherence in Adults With High Blood Pressure (SMS-Text Adherence Support [StAR]): A Single-Blind, Randomized Trial. Circulation. 2016 Feb 9;133(6):592-600. doi: 10.1161/CIRCULATIONAHA.115.017530. Epub 2016 Jan 14.

    PMID: 26769742DERIVED

  • Leon N, Surender R, Bobrow K, Muller J, Farmer A. Improving treatment adherence for blood pressure lowering via mobile phone SMS-messages in South Africa: a qualitative evaluation of the SMS-text Adherence SuppoRt (StAR) trial. BMC Fam Pract. 2015 Jul 3;16:80. doi: 10.1186/s12875-015-0289-7.

    PMID: 26137844DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Lionel Tarassenko, MA, DPhil, FREng, FIET

    University of Oxford

    STUDY CHAIR

  • Andrew Farmer, DM FRCGP

    University of Oxford

    PRINCIPAL INVESTIGATOR

  • Naomi Levitt, MBChB, MD and FCP(SA))

    University of Cape Town

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2013

First Posted

December 24, 2013

Study Start

June 1, 2012

Primary Completion

February 1, 2014

Study Completion

August 1, 2014

Last Updated

November 11, 2014

Record last verified: 2014-11