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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: www.pactr.org

Trial no.: PACTR201302000478315 Date registered: 2013/01/01
TRIAL DESCRIPTION
Public title A RANDOMISED CONTROL TRIAL COMPARING INTENSIVE WITH CONVENTIONAL EDUCATION FOR DIABETES MELLITUS PATIENTS IN CALABAR
Official scientific title A RANDOMISED CONTROL TRIAL COMPARING INTENSIVE WITH CONVENTIONAL EDUCATION FOR DIABETES MELLITUS PATIENTS IN CALABAR
Brief summary describing the background
and objectives of the trial
The care of diabetes mellitus is based on self-management by the patient .This study compares the effectiveness of an intensive group educational programme with the conventional educational programme for all diabetics attending the endocrinology clinic in University of Calabar Teaching Hospital (UCTH). OBJECTIVE To determine whether an intensive educational programme would improve glycosylated haemoglobin (HbA1c) levels when compared with the conventional education for diabetics in UCTH.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied
Purpose of the trial Education/Counselling/Training
Anticipated trial start date 2012-06-01
Actual trial start date 2012-06-01
Anticipated date of last follow up 2013-04-30
Actual date of last follow up 2013-04-30
Anticipated target sample size (number of participants) 100   
Actual target sample size (number of participants) 100   
Recruitment status Open to recruitment: actively recruiting participants
Secondary Ids Issuing authority/Trial register Links to Secondary ID
nil known University of Calabar Teaching Hospital Ethical Committee

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
Factorial: participants randomly allocated to either no,one,some or all interventions simultaneously Randomised Simple randomisation using a randomisation table from a statistics book Allocation was determined by the holder of the sequence who is situated off site Open-label (masking not used)

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control group Conventional education arm once a month 6 months Normal group education programme 50
Experimental group Intensive educattion am twice weekly 6 months Intensive diabetes education with treatment supporter and sms phone recall 50

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
¿ HBA1c > 8.5 % measured before randomization. ¿ Age > 18 years. ¿ Able to exercise. ¿ Available to participate if randomized in the program. ¿ Provision of written informed consent. ¿ Significant eye disease limiting visual acuity. ¿ Lower extremity amputation limiting exercise. ¿ No written informed consent. 18 Years 100 Years 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 2012/05/01 University of Calabar Ethics Committee
Ethics Committee Address
Street address City Postal code Country
University of Calabar Teaching Hospital Calabar PMB 1278 Nigeria

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome significant reduction in HbA1c after 6 months of intensive education After six months

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Calabar Teaching Hospital University of Calabar Calabar PMB 1278 Nigeria

FUNDING SOURCES
Name of source Street address City Postal code Country
Self funded

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Akaninyene Otu University of Calabar Teaching Hospital Calabar PMB 1278 Nigeria Hospital

COLLABORATORS
Name Street address City Postal code Country
Communicable Disease Research/Health and Development, Leeds Institute of Health Sciences, University of Leeds 101 Clarendon Road Leeds Leeds LS2 9LJ United Kingdom

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Dr Okon Essien esso2k2@yahoo.com +2348036541840
Street address City Postal code Country Position / Affiliation
University of Calabar Teaching Hospital Calabar PMB 1278 Nigeria Consultant Endocrinologist
Role Name Email Phone Fax
Scientific Enquiries Dr Akaninyene Otu akanotu@yahoo.com +2348105723133
Street address City Postal code Country Position / Affiliation
University of Calabar Teaching Hospital Calabar PMB 1278 Nigeria Consultant Physician
Role Name Email Phone Fax
Public Enquiries Dr Victor Umoh aaumoh@gmail.com +2348055026582
Street address City Postal code Country Position / Affiliation
University of Calabar Teaching Hospital Calabar PMB 1278 Nigeria Consultant Physician