- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02868320
SMS Technology for the Promotion of Diabetes Education and Self-Management in Egypt
August 11, 2016 updated by: Haitham Abaza, Hannover Medical School
SMS Technology for the Promotion of Diabetes Education and Self-Management
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
73
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Cairo
-
Giza, Cairo, Egypt, 12566
- Misr University for Science & Technology (MUST) hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
This group received a diabetes instruction booklet in addition to daily educational SMS messages and weekly reminders
|
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.
General detailed instructions addressing the same SMS categories.
|
Active Comparator: Control group
This group only received a diabetes instruction booklet
|
General detailed instructions addressing the same SMS categories.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in HbA1c
Time Frame: baseline and 12 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
body weight
Time Frame: 12 weeks
|
12 weeks
|
|
blood glucose levels
Time Frame: 12 weeks
|
12 weeks
|
|
Treatment adherence
Time Frame: 12 weeks
|
measured by the diabetes self-care inventory (SCI)
|
12 weeks
|
Medication adherence
Time Frame: 12 weeks
|
measured by the Morisky medication adherence scale (MMAS-4)
|
12 weeks
|
Diabetes self-efficacy
Time Frame: 12 weeks
|
measured by the diabetes empowerment scale short form (DES-SF)
|
12 weeks
|
Frequency of blood glucose measurement
Time Frame: 12 weeks
|
12 weeks
|
|
Rate of hospital/ER admissions
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Haitham Abaza, PLRI Institute for Medical Informatics, Hannover Medical School
- Study Director: Michael Marschollek, PLRI Institute for Medical Informatics, Hannover Medical School
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2014
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
August 9, 2016
First Submitted That Met QC Criteria
August 11, 2016
First Posted (Estimate)
August 16, 2016
Study Record Updates
Last Update Posted (Estimate)
August 16, 2016
Last Update Submitted That Met QC Criteria
August 11, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DiabAwPro
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes Mellitus
-
University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Diabetes type1 | Type 1 Diabetes Mellitus | Autoimmune Diabetes | Diabetes Mellitus, Insulin-Dependent | Juvenile-Onset Diabetes | Diabetes, Autoimmune | Insulin-Dependent Diabetes Mellitus 1 | Diabetes Mellitus, Insulin-Dependent, 1 | Diabetes Mellitus, Brittle | Diabetes Mellitus, Juvenile-Onset and other conditionsUnited States
-
Guang NingRecruitingType 2 Diabetes Mellitus | Type1 Diabetes Mellitus | Monogenetic Diabetes | Pancreatogenic Diabetes | Drug-Induced Diabetes Mellitus | Other Forms of Diabetes MellitusChina
-
Meir Medical CenterCompletedDiabetes Mellitus Type 2 | Diabetes Mellitus, Non-insulin Dependant | Diabetes Mellitus, on Oral Hypoglycemic Treatment | Adult Type Diabetes MellitusIsrael
-
Peking Union Medical College HospitalUnknownType 2 Diabetes Mellitus | Type 1 Diabetes Mellitus | Gestational Diabetes Mellitus | Pancreatogenic Diabetes Mellitus | Pregestational Diabetes Mellitus | Diabetes Patients in Perioperative PeriodChina
-
Medical College of WisconsinMedical University of South CarolinaCompletedDiabetes Mellitus | Type 2 Diabetes Mellitus | Adult-Onset Diabetes Mellitus | Non-Insulin-Dependent Diabetes Mellitus | Noninsulin Dependent Diabetes Mellitus, Type IIUnited States
-
Hanmi Pharmaceutical Company LimitedUnknownType2 Diabetes Mellitus | Type1 Diabetes MellitusUnited States
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Medical College of WisconsinMedical University of South Carolina; National Institute of Diabetes and Digestive...Active, not recruitingDiabetes Mellitus, Type 2 | Diabetes Mellitus, Type II | Diabetes Mellitus, Adult-Onset | Diabetes Mellitus, Non-Insulin-Dependent | Diabetes Mellitus, Noninsulin DependentUnited States
-
Medical College of WisconsinNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedDiabetes Mellitus, Type 2 | Diabetes Mellitus, Type II | Diabetes Mellitus, Adult-Onset | Diabetes Mellitus, Non-Insulin-Dependent | Diabetes Mellitus, Noninsulin DependentUnited States
-
Medical University of South CarolinaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedDiabetes Mellitus, Type 2 | Diabetes Mellitus, Type II | Diabetes Mellitus, Adult-Onset | Diabetes Mellitus, Non-Insulin-Dependent | Diabetes Mellitus, Noninsulin DependentUnited States
Clinical Trials on SMS messages
-
Young 1oveUniversity of OxfordRecruitingPregnancy Related | Behavior, HealthBotswana
-
African Strategies for HealthUnited States Agency for International Development (USAID)UnknownEffects of the SMS Mother Reminder System on Use of Health Care.Uganda
-
University of MichiganAgency for Healthcare Research and Quality (AHRQ)CompletedMedication Non-adherenceUnited States
-
Imperial College LondonBarts & The London NHS Trust; Mid and South Essex NHS Foundation Trust; Royal... and other collaboratorsCompleted
-
Helen Keller InternationalLondon School of Hygiene and Tropical Medicine; University College, London; United... and other collaboratorsCompleted
-
Massachusetts General HospitalMcKesson FoundationCompleted
-
Aga Khan UniversityUniversity of British Columbia; Grand Challenges CanadaUnknownHepatitis B | Pertussis | Tetanus | Diphtheria | Tuberculosis | Polio | Pneumococcal Infection | Haemophilus Influenzae Type b Infection
-
Monash UniversityNovartis PharmaceuticalsRecruitingCerebrovascular Disease | Coronary Heart Disease (CHD) | Peripheral Arterial Disease (PAD) | Atherosclerotic Cardiovascular Disease (ASCVD)Australia
-
University of Colorado, DenverEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedAdherence to Vaccination Schedules | Timeliness of Vaccination | Acceptability of SMS Reminder ProgramGuatemala
-
University of California, San FranciscoNational Institute of Mental Health (NIMH); The Commonwealth Fund; Agency for...Completed