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.: PACTR201811637528789 Date of Approval: 07/11/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Delta BRIDGES2 Intensive Education and T2D Project
Official scientific title A randomized trial of an intensive education intervention using network of involved diabetes patients to improve glycaemic control of type 2 diabetes patients (Delta State Nigeria)
Brief summary describing the background and objectives of the trial Nigeria has the highest prevalence of diabetes in Sub-Saharan Africa and there is knowledge that obesity is caused by a combination of decreased energy expenditure and increased energy intake. It is also acknowledged that obesity is a potential cause of several health issues that reduce quality of life, and it is confounded or exacerbated by reduced physical activities or sedentary lifestyle
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Diabetes,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/08/2018
Actual trial start date
Anticipated date of last follow up 01/11/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 180
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial 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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Classic Individual consultation 12 months The control group will perform these "classic" individual consultations but will not follow the whole process of peer education. The classical management in diabetes consultations consists of: o A counselling session o A measure of blood glucose o A measurement of blood pressure o A measure of weight and size o A complete clinical examination o A prescription or a renewal of treatment such as diabetes pills, insulin, IEC, and statins o Utilisation of the emojifit diabetes app 90 Placebo
Experimental Group Classic individual consultation plus Life Style counselling 12 months The group subjected to educations will follow the whole process of peer education plus the classical management in diabetes consultations which consists of: o A counselling session o A measure of blood glucose o A measurement of blood pressure o A measure of weight and size o A complete clinical examination o A prescription or a renewal of treatment such as diabetes pills, insulin, IEC, and statins o Utilisation of the emojifit diabetes app Other intervention includes use of network of involved diabetic patients (peer educators) 90
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Patients followed in the diabetes units of the project area and doing regular consultations • Patients with type 2 diabetes • Patients who accepted to undergo the whole process of peer education • Patients who agreed to perform all biological measures included in the protocol • Individuals with intercurrent illnesses who consent to lifestyle and physical activity monitoring • Non-diabetic patients • Patients with type 1 diabetes • Patients with intercurrent illnesses who dissent to lifestyle and physical activity monitoring Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 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 07/11/2017 Human Research Ethics Committee of Novena University
Ethics Committee Address
Street address City Postal code Country
Ogume, Kwale Ogume 0123 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome is changes in the HbA1c levels of the patients at baseline 3, 6 and 12 months.The overreaching judgement criteria in which the analysis will be based will be the superiority of the contribution of the peer education and application of the emojifit app on the evolution of HbA1c from baseline to 12 months. 3, 6, and 12 months
Secondary Outcome The secondary outcome is to compare the changes in bio-clinical parameters and measures of behaviour associated with type 2 diabetes at baseline, 3, 6 and 12 months. Such as weight, body mass index, blood pressure, waist circumference, and cholesterol levels. Other outcomes are expected to include 1. proportion of facilities strengthened for diabetes peer-education 2. proportion of doctors trained on diabetes peer-education and emojifit diabetes app 3. proportion of health workers trained on diabetes peer-education and emojifit diabetes app 4. proportion of diabetes patients informed about peer-education and emojifit diabetes app 5. number of subscriptions to the emojifit diabetes app 6. proportion of diabetes patients organized into Diabetes Association for Peer Education (DAPE) and trained on peer-education 7. number of intensive education classes organized 8. proportion of diabetes participants improving on dietary advice, exercise adherence, and continue to use emojifit app 9. percentage increase in diabetes patients keeping doctor’s appointment for glycaemic check up 10. percentage increase in new diabetes cases presenting at the health centres 3, 6 and 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Catholic Hospital Abbi Ndokwa West LGA Nigeria
Novena University Medical Clinic Ogume Nkwale Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
International Diabetes Federation and Eli Lilly and Company 166 Chaussee de La Hulpe, Brussels Belgium
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor International Diabetes Federation Chaussee de la Hulpe Brussels 1170 Belgium Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Prof Timothy Skinner Department of Psychology, University of Copenhagen Copenhagen Denmark
Dr Victor Oguoma Menzies School of Health Research, Charles Darwin University Darwin 0810 Australia
Prof Ifeoma Ulasi University of Nigeria Teaching Hospital Enugu 402139 Nigeria
Dr Adeseye Akindunde Ladoke Akintola University of Technology Ogbomosho 210214 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ezekiel Nwose enwose@csu.edu.au +61263657282 School of Community Health
City Postal code Country Position/Affiliation
Orange 2800 Australia Charles Sturt University
Role Name Email Phone Street address
Principal Investigator Eunice Igumbor igumboeo@novenauniversity.edu.ng +2348065356475 Department of Public Health
City Postal code Country Position/Affiliation
Ogume 00322 Nigeria Novena University
Role Name Email Phone Street address
Public Enquiries Ezekiel Nwose enwose@csu.edu.au +61263657282 School of Community Health, Charles Sturt University
City Postal code Country Position/Affiliation
Orange 2800 Australia Charles Sturt University
Role Name Email Phone Street address
Scientific Enquiries Ezekiel Nwose enwose@csu.edu.au +61263657282 School of Community Health
City Postal code Country Position/Affiliation
Orange 2800 Australia Charles Sturt University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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