Home » Trials » SLCTR/2016/014
A randomized controlled trial of nurse case management and peer support in improvement of glycemic control among Tamil type II diabetic patients in a selected center in the Batticaloa District
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SLCTR Registration Number
SLCTR/2016/014
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
A randomized controlled trial of nurse case management and peer support in improvement of glycemic control among Tamil type II diabetic patients in a selected center in the Batticaloa District
Public Title of Trial
The impact of Nurse case management and peer support in glycemic control
Disease or Health Condition(s) Studied
Type II diabetes
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
ERC (Sri Jayewardenepura): ERC 06/16
What is the research question being addressed?
What is the effect of Nurse case management and peer support on glycemic control among Tamil type II diabetic patients attending clinics at Teaching Hospital Batticaloa?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Health services research
Study Phase
Not Applicable
Intervention(s) planned
Patients will be recruited from medical clinics at Teaching Hospital, Batticaloa based on inclusion criteria. Selected patients will be randomized into three arms.
Arm 1 will receive only the routine care at clinics
Arm 2 will receive education session by using intervention guideline (prepared by principal investigator (PI)). One hour education session will be conducted at baseline. Afterwards, 30 minutes sessions will be held once per week up to eight weeks from baseline. Ninth and tenth, one hour education sessions will be held at 12 weeks and 16 weeks respectively.
Arm 3 will receive health education sessions as same as arm 2. In addition, peer to peer support sessions will be arranged by PI which will be 30 minutes or more. There will be a peer support session at baseline. Afterwards, each session will be held once per week up to eight weeks from baseline. Ninth and tenth peer support session will be held at 12 weeks and 16 weeks respectively.
All education session will be carried out by PI in Tamil language.
Routine care will be provided to participants in all arms.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
|
[ Baseline, Post-interventions (at 8 weeks, 16 weeks and 32 weeks) ] |
Secondary outcome(s)
|
1.
|
[ Baseline, Post-interventions (at 8 weeks, 16 weeks and 32 weeks) ] |
Target number/sample size
51 (17 in each arm). Assuming 20% loss to follow-up, a total of 61 will be recruited.
Countries of recruitment
Sri Lanka
Anticipated start date
2016-08-01
Anticipated end date
2017-03-31
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
University Research Grant, University of Sri Jayewardenepura, Sri Lanka
Regulatory approvals
Status
Approved
Date of Approval
2016-04-26
Approval number
06/16
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medical Sciences, University of Sri Jayewardenepura |
| Institutional Address: | Gangodawila, Nugegoda Sri Lanka |
| Telephone: | +94-112758000 (Extension: 4075) |
| Email: | erc.fms.usjp@gmail.com |
Contact person for Scientific Queries/Principal Investigator
G Kisokanth
PhD candidate/Lecturer
Faculty of Health Care Sciences, Eastern University, Sri Lanka
0772228330
kiso.1983@yahoo.com
Contact Person for Public Queries
G Kisokanth
PhD candidate/Lecturer
Faculty of Health Care Sciences, Eastern University, Sri Lanka
0772228330
kiso.1983@yahoo.com
Primary study sponsor/organization
University of Sri Jayewardenepura,
Gangodawila, Nugegoda, Sri Lanka.
Tel: +94 11 2758000
Fax: , +94 11 2802022
Email: info@sjp.ac.lk
Web: http://www.sjp.ac.lk/
Secondary study sponsor (If any)
Dr. S. Prathapan
Supervisor/Senior Lecturer
Dept. Community Medicine,
Faculty of Medical Sciences,
University of Sri Jayewardenepura
Tel: 0714852269
drpbshamini@yahoo.com
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
