Home » Trials » SLCTR/2023/019
Effects of nurse-based counselling through WhatsApp, among type 2 diabetes patients at a tertiary care hospital in Sri Lanka: a randomized controlled study.
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SLCTR Registration Number
SLCTR/2023/019
Date of Registration
The date of last modification
Oct 10, 2023
Scientific Title of Trial
Effects of nurse-based counselling through WhatsApp, among type 2 diabetes patients at a tertiary care hospital in Sri Lanka: a randomized controlled study.
Public Title of Trial
Impact of nurse-based WhatsApp Counselling on diabetes medication adherence, severity of adverse drug reactions and hypoglycemic / hyperglycemic complications, among type 2 diabetes patients at a tertiary care hospital in Sri Lanka: a randomized controlled study
Disease or Health Condition(s) Studied
Type 2 Diabetes Mellitus
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1296-2611
Any other number(s) assigned to the trial and issuing authority
None
What is the research question being addressed?
Does nurse-based counselling through WhatsApp improve patient medication adherence, reduce incidence of adverse drug reactions, and reduce hyperglycaemic or hypoglycaemic complications in patients with type 2 diabetes?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Other
Study Phase
Not Applicable
Intervention(s) planned
Method of randomization: a. Block randomization. 1:1 ratio. Block size 2. b. Unit of randomization: Patient unique identity number c. Method of sequence generation:Using a computer software program that generates the random sequence
Intervention: A "live" counselling session delivered through WhatsApp by a “Diabetes Education Nursing Officer”. The intervention will take up 15 minutes. It will include information about diabetes medication and their side effects, healthy eating, exercise, and complications of diabetes. At the end of the intervention patient questions will be entertained and answered by the nursing officer.
Standard care: Diabetes education provided by the medical officers in the medical clinic during their clerking. No blinding
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
The adherence of diabetic patients to their medication regimen will be assessed using the Medication Adherence Rating Scale (MARS). |
[ At intervals of 1 month and 3 months following the intervention ] |
Secondary outcome(s)
|
1.
Frequency of hypoglycaemic/ hyperglycaemic complications and severity of adverse drug reactions. Hypoglycemia: Both self-reported symptoms of hypoglycemia and home/clinic blood sugar measurements (Random blood sugar <70mg/dl). Hyperglycemia: Home/clinic blood sugar measurements (Fasting blood sugar >126 mg/dl and post prandial blood sugar >200 mg/dl). |
[ At intervals of 1 month and 3 months following the intervention ] |
Target number/sample size
566 (283 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2023-10-11
Anticipated end date
2024-02-28
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Self funded
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2023-06-13
Approval number
P/27/04/2023
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya, Ragama, Sri Lanka. |
| Institutional Address: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya, PO Box 06, Thalagolla Road, Ragama, Sri Lanka. |
| Telephone: | +94112961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. J.R.B. Gunasena
Senior Registrar in General Medicine
University Medical Unit, Colombo North Teaching Hospital, Ragama, Sri Lanka.
0719878065
janithag@outlook.com
Contact Person for Public Queries
Professor Shaluka Jayamanne.
Professor in Medicine and Consultant Physician
University Medical Unit, Colombo North Teaching Hospital, Ragama, Sri Lanka.
0773014722
jshalukajaya@kln.ac.lk
Primary study sponsor/organization
Colombo North Teaching Hospital
Hospital Inner Road, Ragama Sri Lanka.
0112959262
info@cnth.health.lk
maria@example.com
https://www.cnth.health.gov.lk/
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
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
