SMS Technology for the Promotion of Diabetes Education and Self-Management in Egypt

Diabetes Mellitus Clinical Trial

Official title:

SMS Technology for the Promotion of Diabetes Education and Self-Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02868320
• Other study ID #: DiabAwPro
• Status: Completed
• Phase: N/A
• First received: August 9, 2016
• Last updated: August 11, 2016
• Start date: April 2014
• Est. completion date: July 2015

Study information

• Verified date: August 2016
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Peter L. Reichertz Institute for Medical Informatics at Hannover Medical SchoolEgypt: MUST Ethical Research Committee at Misr University for Science & Technology
• Study type: Interventional

Clinical Trial Summary

This study was conducted at the teaching hospital of Misr University for Science & Technology. It aimed to examine the use of SMS technology in educating and monitoring diabetic patients in Egypt, and assess the impact of educational text messages on their glycemic control and self-management behaviors. Participants were randomized into an intervention and a control group. Intervention patients received an instruction booklet as well as daily educational and weekly reminder messages to better control their diabetes. Control patients received the same instruction booklet but no SMS messages. Both group patients took an HbA1c test at the beginning and end of the study period and were asked to measure their blood glucose once a week and record their readings into a monitoring table over 12 weeks. The primary outcome was the change in HbA1c levels, which was expected to be greater among intervention patients at the end of the study. Secondary outcomes included blood glucose levels, treatment and medication adherence, diabetes self-efficacy, rate of hospital/ER visits, frequency of blood glucose measurement, among others.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• has diabetes

• owns a mobile phone

• can read SMS messages or lives with someone that can read for them.

Exclusion Criteria:

• cannot read or not SMS familiar and lives alone

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Other:
• SMS messages
Daily educational messages addressing the following categories: diet, exercise, complications, medications, foot care, blood sugar testing, and hypo- and hyperglycemia. Weekly reminder messages of blood glucose testing.
• Instruction booklet
General detailed instructions addressing the same SMS categories.

Locations

Country	Name	City	State
Egypt	Misr University for Science & Technology (MUST) hospital	Giza	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Hannover Medical School	Misr University for Science and Technology

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in HbA1c	measured by the difference between endpoint and baseline values and by the number of patients who experienced a reduction of at least 1% from baseline to endpoint	baseline and 12 weeks	No
Secondary	blood glucose levels		12 weeks	No
Secondary	body weight		12 weeks	No
Secondary	Treatment adherence	measured by the diabetes self-care inventory (SCI)	12 weeks	No
Secondary	Medication adherence	measured by the Morisky medication adherence scale (MMAS-4)	12 weeks	No
Secondary	Diabetes self-efficacy	measured by the diabetes empowerment scale short form (DES-SF)	12 weeks	No
Secondary	Frequency of blood glucose measurement		12 weeks	No
Secondary	Rate of hospital/ER admissions		12 weeks	No