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.: PACTR201302000478315 Date of Approval: 01/01/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
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 Diabetes Mellitus,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/06/2012
Actual trial start date 01/06/2012
Anticipated date of last follow up 30/04/2013
Actual Last follow-up date 30/04/2013
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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
Experimental Group Intensive educattion am twice weekly 6 months Intensive diabetes education with treatment supporter and sms phone recall 50
Control Group Conventional education arm once a month 6 months Normal group education programme 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum 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 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 01/05/2012 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 Street address
Principal Investigator Okon Essien esso2k2@yahoo.com +2348036541840 University of Calabar Teaching Hospital
City Postal code Country Position/Affiliation
Calabar PMB 1278 Nigeria Consultant Endocrinologist
Role Name Email Phone Street address
Public Enquiries Victor Umoh aaumoh@gmail.com +2348055026582 University of Calabar Teaching Hospital
City Postal code Country Position/Affiliation
Calabar PMB 1278 Nigeria Consultant Physician
Role Name Email Phone Street address
Scientific Enquiries Akaninyene Otu akanotu@yahoo.com +2348105723133 University of Calabar Teaching Hospital
City Postal code Country Position/Affiliation
Calabar PMB 1278 Nigeria Consultant Physician
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