Home » Trials » SLCTR/2015/014
Effect of a selected health education programme on metabolic control among patients with type 2 diabetes
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SLCTR Registration Number
SLCTR/2015/014
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
Effect of a selected health education programme on metabolic control among patients with type 2 diabetes
Public Title of Trial
The impact of patient education on controlling Type 2 diabetes
Disease or Health Condition(s) Studied
Type 2 Diabetes Mellitus
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
Ref: H14082 (ERC - Charles Darwin University), Ref: 17.11.2014;3.32 (ERC - Ruhuna)
What is the research question being addressed?
What is the effect of a health education program on glycemic control among Type 2 diabetes patients attending clinics at a tertiary care setting in Sri Lanka?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Health services research
Study Phase
Not Applicable
Intervention(s) planned
Patients will be recruited from diabetic clinics at Teaching Hospital, Karapitiya hospital, Galle and the Colombo South Teaching Hospital.
Participants will be randomized into three arms.
Arm 1 will receive a single health education session at recruitment
Arm 2 will receive a health education session at recruitment and six months later.
Arm 3 will receive standard management according to clinic protocols.
The health education intervention will consist of a single session delivered using a power point presentation in Sinhala Language on a one to one basis (10 minutes) by the Principal Investigator.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
|
[ At baseline, six months and 12 months ] |
Secondary outcome(s)
|
1.
None |
[ None ] |
Target number/sample size
150
Countries of recruitment
Sri Lanka
Anticipated start date
2015-10-01
Anticipated end date
2017-11-17
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Charles Darwin University, Australia and UGC, Sri Lanka (Grant no. UGC/DRIC/PG/2015(i)/RUH/01)
Regulatory approvals
Status
Approved
Date of Approval
2015-02-26
Approval number
17.11.2014:3.32
Details of Ethics Review Committee
| Name: | 7. Ethics Review Committee, Faculty of Medicine, University of Ruhuna |
| Institutional Address: | PO Box 70, Labuduwa Rd, Galle, Sri Lanka |
| Telephone: | +94-91-2234801/803 (Extension: 161) |
| Email: | ethics@med.ruh.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Poornima Cooray
PhD Candidate/ Lecturer
PhD Candidate, Charles Darwin University, Australia
Lecturer, B.Pharm Degree Program, Faculty of Medicine, University of Ruhuna
Tel: +61435209396/ SL: 0714398052
poornimacooray@yahoo.com
Contact Person for Public Queries
Dr. Eisha Waidyarathne
Coordinator, BPharm Degree Program
Faculty of Medicine,
University of Ruhuna,
Sri Lanka
Tel: 077 2988319
eiwaidya@yahoo.co.uk
Primary study sponsor/organization
Prof. P. A Ball
Principal Supervisor/ Theme leader Disciplinary of Pharmacy
Charles Darwin University,
Ellengowan Drive, NT
Australia
08 8946 6127 ext: 6127
08 8946 6338
Patrick.Ball@cdu.edu.au
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
