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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201512001352180 Date of Registration: 19/11/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Ante-natal health promotion via short message service (SMS): advancing access to health knowledge for signing Deaf women in Cape Town.
Official scientific title Health SMSs informing community: Can an SMS based antenatal health promotion address language barriers and advance the right of access to health information for signing Deaf women?
Brief summary describing the background and objectives of the trial Signing Deaf women have an increased likelihood of poor maternal health outcomes. They face significant communication barriers which limits their access to relevant health information. In South Africa, where cell phone penetration and usage is high, this study aimed to increase antenatal health knowledge by disseminating text messages about clinic procedures and how to be healthy during pregnancy. This study employs a before-after (or pre-test-post-test) design. Signing Deaf women (50) aged between 18 and 45 years were recruited via Deaf organisations at two sites in Cape Town ¿ Khayelitsha and Heathfield. A knowledge questionnaire (9 questions) was administered in sign language pre intervention. Thereafter 65 pregnancy related SMSes were delivered to participants¿ cell phones Monday to Friday over 12 weeks (July-September 2013). The same questionnaire with added (eight) health-related behaviour questions was administered at exit ¿ after the intervention. Results are based on 34 responses (eight were lost to follow up and eight were not used because it was not clear if participants received the SMSes). To compare before and after knowledge scores, McNemar¿s test was carried out for binary outcomes and Wilcoxon signed-rank test for all continuous data. The results show that overall there was a statistically significant improvement in knowledge between baseline and exit (p = .0022). The majority of participants indicated that the SMSes had improved their knowledge (81 %). However, 14 percent indicated that the information was irrelevant. Friends, family and colleagues were the most common source for information (43%), followed by written material (35 %). SMSes were used by 32 %. The study concluded that SMSes can improve health knowledge amongst the Deaf. SMS campaigns have the potential to impact on healthy lifestyle by preparing, reminding and motivating people to change.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 29/06/2013
Actual trial start date 29/06/2013
Anticipated date of last follow up 16/11/2013
Actual Last follow-up date 16/11/2013
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
Not applicable Not applicable
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
Non-randomised Not applicable Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Ante-natal health promotion disseminated by mobile phone SMS x 1 per day 12 weeks ¿ start date 8 July 2013 There were 65 health SMSes available in the three local Western Cape languages, ie Xhosa, Afrikaans English, which are the reading and writing languages for local signing Deaf people. Content of the SMSes focused on health information about pregnancy and healthy lifestyle and was appropriate to each trimester. 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The study recruited signing Deaf women of child-bearing age (18-45 years) at two resource poor sites in Cape Town ¿ Khayelitsha and Heathfield. The following groups were excluded: women who were <18 years of age or >45 years of age and who did not have a cell phone 18 Year(s) 45 Year(s) Female
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 12/04/2011 University of Cape Town Health Science Faculty
Ethics Committee Address
Street address City Postal code Country
Groote Schuur Drive Cape Town 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Knowledge levels about pregnancy Prior to the start of the campaign (at recruitment) - End of SMS campaign after the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
(1) Deaf Community of Cape Town Gordon Rd Heathfield Cape Town 7945 South Africa
(2) Noluthando School for Deaf Children Lansdowne Rd Extension, Site B, Cape Town 7784 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
National Research Foundation (NRF) Meiring Naudé Road Pretoria 0184 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Health Science Faculty University of Cape Town Anzio Rd Cape Town 7925 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Hanne Jensen Haricharan Anzio Rd Cape Town 7925 South Africa
Leslie London Anzio Rd Cape Town 7925 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Marion Heap marion.heap@uct.ac.za 084 981 3583 Anzio Rd
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Senior Researcher
Role Name Email Phone Street address
Public Enquiries Marion Heap marion.heap@uct.ac.za 084 981 3583 Anzio Rd
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Senior Researcher
Role Name Email Phone Street address
Scientific Enquiries Marion Heap marion.heap@uct.ac.za 084 981 3583 Anzio Rd
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Senior Researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information