Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201411000724141 Date of Approval: 14/12/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title SMS text message support for patients with hypertension
Official scientific title SMS-text Adherence Support tRial (*StAR)
Brief summary describing the background and objectives of the trial Raised blood pressure is an important and common modifiable risk factor for cardiovascular and related diseases including stroke and chronic kidney disease. . Poor treatment adherence (clinic attendance and medication adherence) is known to be an important, potentially modifiable contributor to uncontrolled hypertension and to hypertension-associated morbidity and early mortality. Interventions delivered using cell-phone technology have been shown to improve clinic attendance and medication adherence for some diseases in resource constrained settings. The efficacy, scalability, and sustainability of using cell-phone technology to support the management of hypertension and other chronic diseases in low resource settings remain to be determined. This trial is designed to determine whether a structured programme of clinic appointment and medication pick-up reminders, medication adherence support and hypertension-related education delivered remotely through informational or interactive SMS-text messages is more effective than usual care in achieving long-term blood pressure control among known hypertensive patients managed in a low-resource primary care setting. Additional objectives include exploring the ability of the intervention to improve clinic appointment attendance and medication adherence, to decrease hypertension related-morbidity and mortality, as well as to improve psychosocial indicators of patient empowerment. Primary outcome measure is mean blood pressure measured at one year. Secondary 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.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) StAR
Disease(s) or condition(s) being studied Hypertension
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/05/2012
Actual trial start date 26/06/2012
Anticipated date of last follow up 28/02/2014
Actual Last follow-up date
Anticipated target sample size (number of participants) 1215
Actual target sample size (number of participants) 1372
Recruitment status Completed
Publication URL http://www.biomedcentral.com/1471-2458/14/28
Secondary Ids Issuing authority/Trial register
SANCTR DOH-27-1212-386 South African National Trials Register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Participants were indvidually randomised using a secure, remote, web-based computer schedule with a minimisation procedure. This was overseen by an independent statistician. Secure, central, web-based randomisation (off-site and independent of the recruiting team) Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Enhanced usual care Infrequent SMS-texts - one per month or less 12-months Non-specific trial related SMS-texts for example, thanking participants for taking part, or wishing them happy birthday 457 Active-Treatment of Control Group
Experimental Group Informational SMS-text intervention One SMS-text per week 12-months Enhanced usual care plus weekly SMS-texts which support treatment adherence (appointment reminders, strategies for integrating taking medicine into every day life, etc) 457
Experimental Group Interactive SMS-text intervention One SMS-text per week 12-months 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 458
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Potential participtans are eligible to participate if: (i)they have existing or confirmed newly diagnosed hypertension and are either currently receiving blood pressure lowering medication or are about to start blood pressure lowering medication, irrespective of co-morbid conditions. (ii) their mean blood pressure at enrolment is < 175/105 iii) they are adults (21 years or older), (iv) they own or have sufficient access to a cell-phone (shared access is allowed if access is daily and the phone owner agrees to participate) (v) they know how to SMS-text (help by a partner is allowed for illiterate subjects, subjects with poor vision, or subjects who are learning disabled) (vi) they currently reside in the study area and expect to be resident for the duration of the study and (ix) they are willing to give informed consent and take part in the study. Ppotential participants will be excluded if: (i) they live in a household where another member has been recruited into the trial (ii) they are pregnant or within three months post-partum by self-report (iii) they do not they currently reside in the study area or are planning to move out of the study area in the next two years (iv) if they are not willing to give written informed consent to take part in the study. 21 Year(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 19/10/2011 Human Research Ethics Committee, University of Cape Town
Ethics Committee Address
Street address City Postal code Country
E52.23 Old Main Building, Groote Schuur Hospital, Groote Schuur Dr Cape Town 7925 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 31/01/2012 Oxford Tropical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Joint Research Office, Churchill Hospital Oxford OX3 7LE United Kingdom
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mean blood pressure at twelve months. Baseline 6-months 12-months
Secondary Outcome The proportion of participants with ¿controlled¿ blood pressure at 12 months, clinic appointment attendance and medication adherence, hypertension related-hospital admission or death, as well as psychosocial indicators of patient empowerment. Baseline 12-months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Vanguard Community Health Centre Candlewood Street Cape Town 7764 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Wellcome Trust Gibbs Building, 215 Euston Road London NW1 2BE United Kingdom
Engineering and Physical Sciences Research Council (EPSRC) Polaris House, North Star Avenue London SN2 1ET United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Oxford Joint Research Office, Churchill Hospital Oxford OX3 7LE United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Department of Medicine, University of Cape Town Groote Scguur Drive Cape Town 7925 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Andrew Farmer andrew.farmer@phc.ox.ac.uk +44 (0) 1865 289 300 New Radcliffe House, 2nd floor, Walton Street, Jericho
City Postal code Country Position/Affiliation
Oxford OX2 6NW United Kingdom Professor General Practice, Department of Primary Care Health Sciences, University of Oxford
Role Name Email Phone Street address
Scientific Enquiries Kirsten Bobrow kirsty.bobrow@phc.ox.ac.uk +27 (0) 848682989 New Radcliffe House, 2nd floor, Walton Street, Jericho
City Postal code Country Position/Affiliation
Oxford OX2 6NW United Kingdom Clinical Researcher, Department of Primary Care Health Sciences, University of Oxford
Role Name Email Phone Street address
Scientific Enquiries Kirsten Bobrow kirsty.bobrow@phc.ox.ac.uk +27 (0) 848682989 New Radcliffe House, 2nd floor, Walton Street, Jericho
City Postal code Country Position/Affiliation
Oxford OX2 6NW United Kingdom Clinical Researcher, Department of Primary Care Health Sciences, University of Oxford
REPORTING
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