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Trial record 66 of 662 for:    SMS

Effectiveness of SMS-text Message Support for Patients With Hypertension to Improve Blood Pressure (*StAR)

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ClinicalTrials.gov Identifier: NCT02019823
Recruitment Status : Completed
First Posted : December 24, 2013
Last Update Posted : November 11, 2014
Sponsor:
Collaborators:
Wellcome Trust
EPSRC
University of Cape Town
Information provided by (Responsible Party):
University of Oxford

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.


Condition or disease Intervention/treatment Phase
Hypertension SMS-text mHealth Behavioral: Informational SMS-text Behavioral: Interactive SMS-text Behavioral: Enhanced usual care Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1372 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official 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.
Study Start Date : June 2012
Actual Primary Completion Date : February 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Enhanced usual care
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
Experimental: Informational SMS-text

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-text
Behavioral: Enhanced usual care
Experimental: Interactive SMS-text
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-text
Behavioral: Interactive SMS-text
Behavioral: Enhanced usual care



Primary Outcome Measures :
  1. Change in systolic blood pressure [ Time Frame: 12-months from baseline ]
    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.


Secondary Outcome Measures :
  1. Measured treatment adherence [ Time Frame: 3-monthly intervals over 12-months of follow-up ]
    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.


Other Outcome Measures:
  1. Proportion of participants with a systolic blood pressure < 140 mmHg and a diastolic blood pressure <90 mmHg [ Time Frame: At 12-months ]
  2. Hospital admissions for hypertension related illnesses [ Time Frame: At 12-months ]
  3. Self-reported health status [ Time Frame: At 12-months ]
    EuroQol 5-Dimension and Visual Analogue Scale

  4. Proportion of scheduled clinic appointments attended [ Time Frame: At 12-months ]
  5. Satisfaction with clinic services and care [ Time Frame: At 12-months ]
    Assessed using 12 5-point Likert-scale items adapted from locally appropriate questionnaires developed to capture patient satisfaction with services.

  6. Self-reported adherence to antihypertensive treatment [ Time Frame: At 12-months ]
  7. Basic knowledge about hypertension [ Time Frame: At 12-months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02019823


Sponsors and Collaborators
University of Oxford
Wellcome Trust
EPSRC
University of Cape Town
Investigators
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Study Chair: Lionel Tarassenko, MA, DPhil, FREng, FIET University of Oxford
Principal Investigator: Andrew Farmer, DM FRCGP University of Oxford
Principal Investigator: Naomi Levitt, MBChB, MD and FCP(SA)) University of Cape Town

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT02019823     History of Changes
Other Study ID Numbers: SMSBP
NHREC# 2868 ( Registry Identifier: South African National Clinical Trials Register )
418/2011 ( Other Identifier: University of Cape Town Human Subjects Research Ethics Committee )
141/2011 ( Other Identifier: Western Cape Province Department of Health Research Committee )
First Posted: December 24, 2013    Key Record Dates
Last Update Posted: November 11, 2014
Last Verified: November 2014
Keywords provided by University of Oxford:
SMS-text
mobile health
mHealth
treatment
adherence
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases