Comparison of the effectiveness of SMS as a tool for health education in families of children with type 1 Diabetes Mellitus in improving glycaemic control
To determine the efficacy of SMS as a tool for health education in families of children with Type 1 Diabetes Mellitus.
Design
Single blind randomized control trial
Settings and conduct
Tertiary care hospitals in Rawalpindi
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 1 to 18 yrs; using subcutaneous insulin; ability to read and understand urdu by the patient or the care giver; possession and regular usage of a mobile phone by the patient or the care giver. Exclusion criteria: using oral hypoglycemic drugs concomitantly; advanced diabetic complication and end organ involvement; syndromic causes of diabetes; unwilling to participate in the study.
Intervention groups
SMS containing educative material regarding T1DM and its management sent to the interventional group 4 days a week.
Main outcome variables
HbA1c and BSF
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210216050380N1
Registration date:2021-03-06, 1399/12/16
Registration timing:retrospective
Last update:2021-03-06, 1399/12/16
Update count:0
Registration date
2021-03-06, 1399/12/16
Registrant information
Name
Asbah Rahman
Name of organization / entity
Combined Military Hospital, Rawalpindi
Country
Pakistan
Phone
+92 51 5419586
Email address
asbahrahman@hotmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-01, 1399/11/13
Expected recruitment end date
2021-03-01, 1399/12/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of SMS as a tool for health education in families of children with type 1 Diabetes Mellitus in improving glycaemic control
Public title
Effectiveness of SMS as a tool for health education in families of children with type 1 Diabetes Mellitus
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age from 1 yrs to 18yrs
Using subcutaneous insulin
Ability to read and understand urdu by the patient or the care giver
Possession and regular usage of a mobile phone by the patient or the care giver
Exclusion criteria:
Using oral hypoglycemic drugs concomitantly
Advanced diabetic complication and end organ involvement
Syndromic causes of diabetes
Unwilling to participate in the study
Age
From 1 year old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
11
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual Randomisation. tool used for randomization was lottery method.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants were randomly divided into the intervention and control group. The healthcare providers of both groups were blinded to the fact that one group is receiving an intervention. Hence both groups received standard care as per the routine. The intervention group would receive SMS but the control group did not receive any SMS and they did not know about the intervention. The principle investigator and data collector would know which participant is allocated to which group.
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Pak Emirates Military Hospital
Street address
The Mall, Rawalpindi
City
Rawalpindi
Postal code
74600
Approval date
2021-01-26, 1399/11/07
Ethics committee reference number
A/28/EC/249/2021
Health conditions studied
1
Description of health condition studied
E10
ICD-10 code
E10
ICD-10 code description
Type 1 diabetes mellitus
Primary outcomes
1
Description
HbA1c
Timepoint
before the intervention begins and after the intervention ends
Method of measurement
laboratory
Secondary outcomes
1
Description
maintaining a diary
Timepoint
before the intervention begins and after the intervention ends
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group:
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
tertiary care Hospitals of Rawalpindi
Full name of responsible person
Asbah Rahman
Street address
The Mall, Rawalpindi
City
Rawalpindi
Postal code
74600
Phone
+92 51 5419586
Email
asbahrahman@hotmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
pak emirates Military Hospital
Full name of responsible person
Asbah Rahman
Street address
The Mall, Rawalpindi
City
Rawalpindi
Postal code
74600
Phone
+92 51 5419586
Email
asbahrahman@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
pak emirates Military Hospital
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Pak Emirates Military Hospital
Full name of responsible person
Asbah Rahman
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
The Mall, Rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
74600
Phone
+92 330 9356065
Email
asbahrahman@hotmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Pak Emirates Military Hospital
Full name of responsible person
Asbah RAhman
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
The Mall, Rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
74600
Phone
+92 330 9356065
Email
asbahrahman@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
Pakemirates Military Hospital
Full name of responsible person
Asbah Rahman
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
The Mall, Rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
74600
Phone
+92 330 9356065
Email
asbahrahman@hotmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available