NCT02868320

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed
Last Updated

August 16, 2016

Status Verified

August 1, 2016

Enrollment Period

1.2 years

First QC Date

August 9, 2016

Last Update Submit

August 11, 2016

Conditions

Diabetes Mellitus

Keywords

SMStext messagingdiabetes self managementglycemic controlmHealthmobile healthdiabetes education

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (7)

  • blood glucose levels

    12 weeks

  • body weight

    12 weeks

  • Treatment adherence

    12 weeks

  • Medication adherence

    12 weeks

  • Diabetes self-efficacy

    12 weeks

  • +2 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

This group received a diabetes instruction booklet in addition to daily educational SMS messages and weekly reminders

Other: SMS messagesOther: Instruction booklet

Control group

ACTIVE COMPARATOR

This group only received a diabetes instruction booklet

Other: Instruction booklet

Interventions

SMS messagesOTHER

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.

Intervention group
Instruction bookletOTHER

General detailed instructions addressing the same SMS categories.

Control groupIntervention group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • has diabetes
  • owns a mobile phone
  • can read SMS messages or lives with someone that can read for them.

You may not qualify if:

  • cannot read or not SMS familiar and lives alone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Misr University for Science & Technology (MUST) hospital

Giza, Cairo Governorate, 12566, Egypt

Location

Related Publications (1)

  • Abaza H, Marschollek M. SMS education for the promotion of diabetes self-management in low & middle income countries: a pilot randomized controlled trial in Egypt. BMC Public Health. 2017 Dec 19;17(1):962. doi: 10.1186/s12889-017-4973-5.

    PMID: 29258499DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Haitham Abaza

    PLRI Institute for Medical Informatics, Hannover Medical School

    PRINCIPAL INVESTIGATOR

  • Michael Marschollek

    PLRI Institute for Medical Informatics, Hannover Medical School

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral candidate at PLRI Institute for Medical Informatics

Study Record Dates

First Submitted

August 9, 2016

First Posted

August 16, 2016

Study Start

April 1, 2014

Primary Completion

June 1, 2015

Study Completion

July 1, 2015

Last Updated

August 16, 2016

Record last verified: 2016-08

Locations

EG(1)