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.: PACTR201802003031831 Date of Approval: 30/01/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title mHealth Coaching for Patient Self-Care
Official scientific title mHealth Coaching for Patient Self-Care: a pilot randomised controlled trial
Brief summary describing the background and objectives of the trial Adherence to pharmacotherapy is a major impediment to chronic condition health outcomes, especially in developing countries. Two developing health-related trends may offer a cost-effective solution to poor adherence and other self-care behaviours, namely; mobile health technology (mHealth) and health coaching. The pilot study compared a standard telephonic health coaching intervention with a novel mobile phone enabled health coaching application (App) developed by UpForIt Coaching (Pty) Ltd, in fostering patient adherence to medication in an insured South African population previously identified as being at high risk for chronic diseases.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Chronic disease
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/06/2017
Actual trial start date 12/06/2017
Anticipated date of last follow up 31/08/2017
Actual Last follow-up date 07/09/2017
Anticipated target sample size (number of participants) 4417
Actual target sample size (number of participants) 826
Recruitment status Stopped early/ terminated
Publication URL
Secondary Ids Issuing authority/Trial register
Pharma-Ethics 170516550
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 online random number generator Offsite randomisation Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group UpForIt Coaching n/a 90 days mHealth adherence promoting 413
Control Group Active Disease Risk Management n/a 90 days Telephonic adherence promoting 413
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Insured population previously classified as 'high risk' for chronic disease. Access to a 'smart' mobile phone Able to read, write and speak English Under the age of 18 years old No access to a 'smart' phone Not able to read, write and speak English 18 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 28/08/2017 Pharma-Ethics
Ethics Committee Address
Street address City Postal code Country
123 Amcor Road Pretoria 0157 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Adherence Baseline and 90 days post-baseline
Secondary Outcome Nil Not applicable
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Medscheme Searle Street Cape Town South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Medscheme Searle street Cape Town South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor UpForIt Coaching (Pty) Ltd Leslie Road Johannesburg 2055 South Africa Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Peter Hill PO Box 779 Melkbosstrand 7437 South Africa
Lona Baragona 10 Sunset Clam Lane Cape Town 7441 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Peter Hill peterh@upforit.co.za +27829285020 10 Sunset Clam Lane
City Postal code Country Position/Affiliation
7441 South Africa Chief Scientific Officer
Role Name Email Phone Street address
Public Enquiries Peter Hill peterh@upforit.co.za +27829285020 10 Sunset Clam Lane
City Postal code Country Position/Affiliation
Melkbosstrand 7441 South Africa Chief Scientific Officer
Role Name Email Phone Street address
Scientific Enquiries Peter Hill peterh@upforit.co.za +27829285020 10 Sunset Clam Lane
City Postal code Country Position/Affiliation
Melkbosstrand 7441 South Africa Chief Scientific Officer
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information