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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 -

SLCTR Registration Number

SLCTR/2016/014


Date of Registration

10 Jun 2016

The date of last modification

Jun 10, 2016



Application Summary


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 of Health Condition(s) Studied

Type II diabetes


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trail Number

None


Any other number(s) assigned to the trial and issuing authority

ERC (Sri Jayewardenepura): ERC 06/16


Trial Details


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


Assignment

Parallel


Purpose

Health services research


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

  1. Tamils who have lived at least for 2 years in the Batticaloa district
  2. Type-II DM
  3. Diagnosed at least 2 years ago and treated with oral hypoglycemic agents or insulin
  4. Age between 30 – 70 years
  5. No concurrent participation in another research study
  6. Ability to provide informed consent

Exclusion criteria

  1. Type I diabetes
  2. Uncontrolled hypertension (blood pressure > 180/110 mm hg)
  3. Unstable angina (class 4)
  4. Myocardial infarction in the past 6 months
  5. Two or more episodes of seizures
  6. Documented alcoholism or drug abuse
  7. Late-stage complications of diabetes
  8. Other chronic conditions, such as     a) Cirrhosis     b) End stage renal disease     c) Any type of malignancy     d) Heart failure


Primary outcome(s)

  1. Glycosylated Hemoglobin (HbA1c)
  2. Lipid profile

Primary outcome(s) - Time of assessment(s)

Baseline, Post-interventions (at 8 weeks, 16 weeks and 32 weeks)


Secondary outcome

  1. BMI
  2. Blood pressure
  3. Waist and hip circumference

Secondary outcome(s) - Time of assessment(s)

  1. BMI
  2. Blood pressure
  3. Waist and hip circumference


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


Recruitment status

Pending


State of ethics review approval

Approved by the Ethics Review Committee, Faculty of Medical Sciences, University of Sri Jayewardenepura on 26th April 2016 (Ref: 06/16)


Funding source

University Research Grant, University of Sri Jayewardenepura, Sri Lanka



Contact & Sponsor Information


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