Diabetes MellitusNCT02868320
SMS Technology for the Promotion of Diabetes Education and Self-Management in Egypt
A study testing SMS messages and Instruction booklet in people with Diabetes Mellitus, run by Hannover Medical School at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- SMS messages and Instruction booklet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2014to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- has diabetes
- owns a mobile phone
- can read SMS messages or lives with someone that can read for them.
Who cannot join
- cannot read or not SMS familiar and lives alone
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Misr University for Science & Technology (MUST) hospital
Giza, Cairo Governorate, 12566
About this study
Official title: 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.
- Conditions
- Diabetes Mellitus
- Being tested
- SMS messages, Instruction booklet
- Keywords
- SMS, text messaging, diabetes self management, glycemic control, mHealth, mobile health, diabetes education
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Instruction bookletOther
General detailed instructions addressing the same SMS categories.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | This group received a diabetes instruction booklet in addition to daily educational SMS messages and weekly reminders Receives: Other: SMS messages; Other: Instruction booklet |
| Control group | Active comparator | This group only received a diabetes instruction booklet Receives: Other: Instruction booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline and 12 weeks
Secondary outcomes (7)
blood glucose levels
Measured: 12 weeks
body weight
Measured: 12 weeks
Treatment adherence
measured by the diabetes self-care inventory (SCI)
Measured: 12 weeks
Medication adherence
measured by the Morisky medication adherence scale (MMAS-4)
Measured: 12 weeks
Diabetes self-efficacy
measured by the diabetes empowerment scale short form (DES-SF)
Measured: 12 weeks
Frequency of blood glucose measurement
Measured: 12 weeks
Rate of hospital/ER admissions
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startApr 2014
- Primary completionJun 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Misr University for Science and Technology
- Responsible party
- Principal investigator, Haitham Abaza, Hannover Medical School
- Investigators
- Haitham Abaza, Principal investigator, PLRI Institute for Medical Informatics, Hannover Medical SchoolMichael Marschollek, Study director, PLRI Institute for Medical Informatics, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02868320
- Sponsor's protocol ID
- DiabAwPro
- Status last verified
- Aug 2016
- First submitted
- 9 Aug 2016
- Last updated
- 16 Aug 2016
- Results posted
- No
Publications
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.
PubMed 29258499
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMS Technology for the Promotion of Diabetes Education and Self-Management
- ClinicalTrials.gov ID
- NCT02868320
- Acronym / sponsor ID
- DiabAwPro
- Conditions
- Diabetes Mellitus
- Keywords
- SMS, text messaging, diabetes self management, glycemic control, mHealth, mobile health, diabetes education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- Misr University for Science and Technology
- Study start
- Apr 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 16 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: SMS messages, Other: Instruction bookletThis group received a diabetes instruction booklet in addition to daily educational SMS messages and weekly reminders |
| Control group | Active comparator | Other: Instruction bookletThis group only received a diabetes instruction booklet |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- has diabetes
- owns a mobile phone
- can read SMS messages or lives with someone that can read for them.
Key exclusion criteria (1 listed)
- cannot read or not SMS familiar and lives alone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMS messagesDaily 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. | Other | Intervention group |
| Instruction bookletGeneral detailed instructions addressing the same SMS categories. | Other | Control group, Intervention group |
Primary outcome
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
7 secondary outcomes
blood glucose levels
Time frame: 12 weeks
body weight
Time frame: 12 weeks
Treatment adherence
Time frame: 12 weeks
Medication adherence
Time frame: 12 weeks
Diabetes self-efficacy
Time frame: 12 weeks
Frequency of blood glucose measurement
Time frame: 12 weeks
Rate of hospital/ER admissions
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2016.
- Derived from this study: PubMed 29258499Abaza 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haitham Abaza principal investigator
PLRI Institute for Medical Informatics, Hannover Medical School
Michael Marschollek study director
PLRI Institute for Medical Informatics, Hannover Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMS messages and Instruction booklet in people with Diabetes Mellitus, run by Hannover Medical School at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in HbA1c (time frame: baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02868320, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2016.