Diabetes MellitusNCT06176495
Empowering Patients With Diabetes and Their Family Members: Assessing the Impact of Free Informative Mobile Messages
A study testing Educational Text Messages in people with Diabetes Mellitus, run by American University of Beirut Medical Center.
Trial summary
This is a Randomized Control Trial aiming at investigating the feasibility and effectiveness of a WhatsApp-based informative intervention on Diabetes Mellitus care in Lebanon and exploring the impact of this intervention on various aspects of Diabetes management and patient outcomes. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Educational Text Messages
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Nov 2024
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients 18 years or older
- Patients with an established DM diagnosis
- Patients with a recent HbA1c level with no recent changes in treatment regimen
- Recent HbA1c > 7 but less than 9
- Patients who are on oral antidiabetic medications or basal insulin (intermediate, long acting, ultra long acting insulin)
- Patients who are adherents to the American University of Beirut Health Insurance Plan (AUB-HIP)
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- Patients who have visited the Family Medicine Primary Care Clinics at American University of Beirut Clinics in the past 12 months.
- Patients with smart mobile phones and/or access to WhatsApp services
- Patients who can speak and read Arabic or English or live with someone who can read for them
- Patients with available family members involved in their care (e.g. cooking, aiding in management, securing/delivering medications, having the patient medically insured, etc.).
- Willingness to participate in the study
- Age 18 years or older
- Designated or selected by the participating patient with diabetes.
- Not diagnosed with DM
- Can read and write
- No visual or hearing impairments
- Involved in the participant's diabetes or general care and has an influence on the participant's lifestyle behaviors or medical insurance (e.g. cooking, aiding in management, securing/delivering medications, having the patient medically insured, etc.).
- Access to the WhatsApp service
- Willingness to participate in the study
Who cannot join
- Young patients below 18 years
- Patients who are on non basal insulin/bolus therapy
- Adults with cognitive impairment
- Adults with functional dependence and no assisting family member or caregiver
- Pregnant and Postpartum patients
- Patients with terminal or critical diseases (e.g., cancer; advanced heart, lung, liver, and kidney disease; Human immunodeficiency virus infection and Acquired immune deficiency syndrome and etc.)
Show all 10Show fewer
- Patients with severe hearing or visual impairment
- Patients who can't read or have difficulty reading and do not live with someone who can read for them
- Patients who will have any of their medications modified throughout the study process will be excluded from the study as well
- Patients with a positive depression (PHQ 2) and/or anxiety (GAD 2) screening results who will be asked to follow up with their primary physician
Trial locations and contacts
No sites are listed yet.
About this study
This is a Randomized Control Trial aiming at investigating the feasibility and effectiveness of a WhatsApp-based informative intervention on Diabetes Mellitus care in Lebanon and exploring the impact of this intervention on various aspects of Diabetes management and patient outcomes.
Family member caregivers will be also included in this interventional study as the research investigators opt to evaluate their DM related knowledge, personal health practices, their involvement in the care of patients with diabetes, and their impact on the patients' diabetes control before and after the intervention.
Read the detailed description
Participants with diabetes will be equally and randomly divided into an intervention group (patients with diabetes and their designated family member) of individualized WhatsApp groups which will include each participant individually and the study coordinator to protect their privacy; regular, 4-5 diabetes educational messages a week for a total of 12 weeks will be sent by noon (around 12 pm) to the intervention group participants. The other group, control group, will receive no text messages throughout this period. After 3 months, participants of the intervention group (patients with diabetes and their family members) will be asked to fill in a postintervention knowledge and practices questionnaire to delineate any marked differences in the context of knowledge and health behaviors. All participants with diabetes of both groups will be asked to recheck the previously noted clinical and laboratory parameters at 12 weeks to evaluate for any changes particularly among the intervention group who will also be asked to fill out a postintervention survey. After 6 months, all patients with diabetes will be asked to recheck their clinical and laboratory values again and members of the intervention group will be asked to fill in the practices section questionnaire again.
This research will additionally include Family Members of patients with diabetes who are involved in their care (cooking, aiding in management, securing/delivering medications, etc.). Family Member Caregivers of participants will be designated/noted by the participants who have diabetes themselves, and they will be included in the study based on their willingness to take part of the study. They will also be sorted into either a control or an intervention group in accordance with which group their relative with diabetes was sorted into, for example, if the patient with diabetes will be designated to be a part of the intervention group, this means that the family member caregiver participant will also be allocated to the intervention group. Our aim is to evaluate their DM related knowledge, personal health practices, their involvement in the care of patients with diabetes, and their impact on the patients' diabetes control before and after the intervention.
One point to note as well is that to ensure equality among groups and for the benefit of the control group participants, the research investigators will be sharing with them the content of the text messages originally shared with the participants of the intervention group by the End of the study.
- Conditions
- Diabetes Mellitus
- Being tested
- Educational Text Messages
- Keywords
- Diabetes Mellitus, Family Member Caregivers, Education, Educational text messages, WhatsApp
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Text MessagesDiagnostic test
The educational content will be targeted about Diabetes Education and will be guideline based with what complies to the standards of care instituted by the American Diabetes Association.
They text messages will comprise content related to general diabetes knowledge, diabetes management and control, coping with diabetes, and guidance on adopting a healthy lifestyle.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Patients with Diabetes and Family Member Caregivers who will receive no text messages over the designated period of the designated |
| Intervention Group | Other | Patients with Diabetes and Family Member Caregivers who will receive Educational Text Messages via WhatsApp over the designated period of the intervention Receives: Diagnostic Test: Educational Text Messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in glycemic control determined by HbA1C (in percent) in participants with diabetes pre and post intervention.
To determine the effectiveness of diabetes tailored text messages on glycemic control in patients with diabetes mellitus, Percentage change in glycemic control determined by HbA1C (in percent) in participants with diabetes pre and post intervention will be assessed.
Measured: at 3 and 6 months interval
Secondary outcomes (8)
Change in knowledge before and after the intervention (in percentage)
Assessment of the change in percentage of knowledge in both the patients' and family members' that will be assessed based on the questionnaire that is to be filled before and after the intervention.
Chi-squared test will be utilised with a p-value of ≤ 0.05 being considered as statistically significant.
Measured: at 3 and 6 months interval
Changes in Daily Health Practices pre and post intervention (in percentage)
the participants daily health practices will be assessed using a designed questionnaire. the changes in health practices will be assessed pre and post intervention using delta percentage.
Chi-squared test will be utilised with a p-value of ≤ 0.05 being considered as statistically significant.
Measured: at 3 and 6 months interval
Percentage change in weight (in Kg), height (in meters) and BMI (Kg/m2) pre and post intervention
Percentage change in weight (in kg), height ( in meters) and BMI (in Kg/m2) pre and post intervention in participants with diabetes
Measured: At 3 and 6 months interval
Percentage change in fasting sugar (mg/dl) pre and post intervention among participants with diabetes
Percentage change in fasting sugar (mg/dl) pre and post intervention among participants with diabetes
Measured: At 3 and 6 months interval
Percentage change in lipid profile composed of Total Cholesterol, LDL, HDL and Triglycerides ( all in mg/dl) among participants with diabetes pre and post intervention
Percentage change in lipid profile composed of Total Cholesterol, LDL, HDL and Triglycerides ( all in mg/dl) among participants with diabetes pre and post intervention
Measured: At 3 and 6 months interval
Percentage change in systolic and diastolic blood pressure (in mmHg) in participants with diabetes pre and post intervention
Percentage change in systolic and diastolic blood pressure (in mmHg) in participants with diabetes pre and post intervention
Measured: At 3 and 6 months interval
Assessment of Changes in Depression Screening score (in percentage pre and post intervention)
Changes in patients' depression screening score pre and post intervention using the PHQ 2 scaled score. This will be reflected in percentage (pre and post intervention) to reflect the changes in the participants' mood. Chi-squared test will be utilised with a p-value of ≤ 0.05 being considered as statistically significant.
For the PHQ-2, the score ranges from 0-6. A score of 3 is considered as the optimal cut point when using the PHQ-2 to screen for depression. If the score is 3 or greater, major depressive disorder is likely.
Measured: At 3 and 6 months interval
Assessment of Changes in Anxiety Screening score (in percentage pre and post intervention)
Changes in patients' anxiety screening score pre and post intervention using the GAD 2 scaled score. This will be reflected in percentage (pre and post intervention) to reflect the changes in the participants' mood. Chi-squared test will be utilised with a p-value of ≤ 0.05 being considered as statistically significant.
For the GAD-2, the score ranges from 0-6. A score of 3 is considered as the optimal cut point when using the GAD-2 to screen for generalised anxiety. If the score is 3 or greater, generalised anxiety is likely.
Measured: At 3 and 6 months interval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study startJan 2024 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Najla El Lakkis, American University of Beirut Medical Center
- Investigators
- Najla El Lakkis, FAM MED, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06176495
- Sponsor's protocol ID
- SBS-2023-0225
- Status last verified
- Dec 2023
- First submitted
- 21 Nov 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Al-Mutawaa KA, Farghaly AH, Nasir R, Loares AM, Skaroni I, Al-Thani M, Abou-Samra AB. Level of knowledge, attitude and practice towards diabetes among nationals and long-term residents of Qatar: a cross-sectional study. BMJ Open. 2022 Feb 16;12(2):e052607. doi: 10.1136/bmjopen-2021-052607.
PubMed 35172997Abaza 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 29258499Ernawati U, Wihastuti TA, Utami YW. Effectiveness of diabetes self-management education (DSME) in type 2 diabetes mellitus (T2DM) patients: Systematic literature review. J Public Health Res. 2021 Apr 14;10(2):2240. doi: 10.4081/jphr.2021.2240.
PubMed 33855427Karaoui LR, Deeb ME, Nasser L, Hallit S. Knowledge and practice of patients with diabetes mellitus in Lebanon: a cross-sectional study. BMC Public Health. 2018 Apr 20;18(1):525. doi: 10.1186/s12889-018-5416-7.
PubMed 29678148Sahin C, Courtney KL, Naylor PJ, E Rhodes R. Tailored mobile text messaging interventions targeting type 2 diabetes self-management: A systematic review and a meta-analysis. Digit Health. 2019 Apr 22;5:2055207619845279. doi: 10.1177/2055207619845279. eCollection 2019 Jan-Dec.
PubMed 31041110Bin Abbas B, Al Fares A, Jabbari M, El Dali A, Al Orifi F. Effect of mobile phone short text messages on glycemic control in type 2 diabetes. Int J Endocrinol Metab. 2015 Jan 1;13(1):e18791. doi: 10.5812/ijem.18791. eCollection 2015 Jan.
PubMed 25745493Omar MA, Hasan S, Palaian S, Mahameed S. The impact of a self-management educational program coordinated through WhatsApp on diabetes control. Pharm Pract (Granada). 2020 Apr-Jun;18(2):1841. doi: 10.18549/PharmPract.2020.2.1841. Epub 2020 May 3.
PubMed 32477434
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowering Patients With Diabetes and Their Family Members: Assessing the Impact of Free Informative Mobile Messages
- ClinicalTrials.gov ID
- NCT06176495
- Acronym / sponsor ID
- SBS-2023-0225
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes Mellitus, Family Member Caregivers, Education, Educational text messages, WhatsApp
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 19 Dec 2023 (actual)
- 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 is a Randomized Control Trial aiming at investigating the feasibility and effectiveness of a WhatsApp-based informative intervention on Diabetes Mellitus care in Lebanon and exploring the impact of this intervention on various aspects of Diabetes management and patient outcomes.
Family member caregivers will be also included in this interventional study as the research investigators opt to evaluate their DM related knowledge, personal health practices, their involvement in the care of patients with diabetes, and their impact on the patients' diabetes control before and after the intervention.
Detailed description
Participants with diabetes will be equally and randomly divided into an intervention group (patients with diabetes and their designated family member) of individualized WhatsApp groups which will include each participant individually and the study coordinator to protect their privacy; regular, 4-5 diabetes educational messages a week for a total of 12 weeks will be sent by noon (around 12 pm) to the intervention group participants. The other group, control group, will receive no text messages throughout this period. After 3 months, participants of the intervention group (patients with diabetes and their family members) will be asked to fill in a postintervention knowledge and practices questionnaire to delineate any marked differences in the context of knowledge and health behaviors. All participants with diabetes of both groups will be asked to recheck the previously noted clinical and laboratory parameters at 12 weeks to evaluate for any changes particularly among the intervention group who will also be asked to fill out a postintervention survey. After 6 months, all patients with diabetes will be asked to recheck their clinical and laboratory values again and members of the intervention group will be asked to fill in the practices section questionnaire again.
This research will additionally include Family Members of patients with diabetes who are involved in their care (cooking, aiding in management, securing/delivering medications, etc.). Family Member Caregivers of participants will be designated/noted by the participants who have diabetes themselves, and they will be included in the study based on their willingness to take part of the study. They will also be sorted into either a control or an intervention group in accordance with which group their relative with diabetes was sorted into, for example, if the patient with diabetes will be designated to be a part of the intervention group, this means that the family member caregiver participant will also be allocated to the intervention group. Our aim is to evaluate their DM related knowledge, personal health practices, their involvement in the care of patients with diabetes, and their impact on the patients' diabetes control before and after the intervention.
One point to note as well is that to ensure equality among groups and for the benefit of the control group participants, the research investigators will be sharing with them the content of the text messages originally shared with the participants of the intervention group by the End of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Patients with Diabetes and Family Member Caregivers who will receive no text messages over the designated period of the designated |
| Intervention Group | Other | Diagnostic Test: Educational Text MessagesPatients with Diabetes and Family Member Caregivers who will receive Educational Text Messages via WhatsApp over the designated period of the intervention |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Adult patients 18 years or older
- Patients with an established DM diagnosis
- Patients with a recent HbA1c level with no recent changes in treatment regimen
- Recent HbA1c > 7 but less than 9
- Patients who are on oral antidiabetic medications or basal insulin (intermediate, long acting, ultra long acting insulin)
Key exclusion criteria (10 listed)
- Young patients below 18 years
- Patients who are on non basal insulin/bolus therapy
- Adults with cognitive impairment
- Adults with functional dependence and no assisting family member or caregiver
- Pregnant and Postpartum patients
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 |
|---|---|---|
| Educational Text MessagesThe educational content will be targeted about Diabetes Education and will be guideline based with what complies to the standards of care instituted by the American Diabetes Association. They text messages will comprise content related to general diabetes knowledge, diabetes management and control, coping with diabetes, and guidance on adopting a healthy lifestyle. | Diagnostic test | Intervention Group |
Primary outcome
Percentage change in glycemic control determined by HbA1C (in percent) in participants with diabetes pre and post intervention.
Time frame: at 3 and 6 months interval
To determine the effectiveness of diabetes tailored text messages on glycemic control in patients with diabetes mellitus, Percentage change in glycemic control determined by HbA1C (in percent) in participants with diabetes pre and post intervention will be assessed.
8 secondary outcomes
Change in knowledge before and after the intervention (in percentage)
Time frame: at 3 and 6 months interval
Changes in Daily Health Practices pre and post intervention (in percentage)
Time frame: at 3 and 6 months interval
Percentage change in weight (in Kg), height (in meters) and BMI (Kg/m2) pre and post intervention
Time frame: At 3 and 6 months interval
Percentage change in fasting sugar (mg/dl) pre and post intervention among participants with diabetes
Time frame: At 3 and 6 months interval
Percentage change in lipid profile composed of Total Cholesterol, LDL, HDL and Triglycerides ( all in mg/dl) among participants with diabetes pre and post intervention
Time frame: At 3 and 6 months interval
Percentage change in systolic and diastolic blood pressure (in mmHg) in participants with diabetes pre and post intervention
Time frame: At 3 and 6 months interval
Assessment of Changes in Depression Screening score (in percentage pre and post intervention)
Time frame: At 3 and 6 months interval
Assessment of Changes in Anxiety Screening score (in percentage pre and post intervention)
Time frame: At 3 and 6 months interval
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Background: PubMed 35172997Al-Mutawaa KA, Farghaly AH, Nasir R, Loares AM, Skaroni I, Al-Thani M, Abou-Samra AB. Level of knowledge, attitude and practice towards diabetes among nationals and long-term residents of Qatar: a cross-sectional study. BMJ Open. 2022 Feb 16;12(2):e052607. doi: 10.1136/bmjopen-2021-052607.
- Results publication: 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.
- Results publication: PubMed 33855427Ernawati U, Wihastuti TA, Utami YW. Effectiveness of diabetes self-management education (DSME) in type 2 diabetes mellitus (T2DM) patients: Systematic literature review. J Public Health Res. 2021 Apr 14;10(2):2240. doi: 10.4081/jphr.2021.2240.
- Results publication: PubMed 29678148Karaoui LR, Deeb ME, Nasser L, Hallit S. Knowledge and practice of patients with diabetes mellitus in Lebanon: a cross-sectional study. BMC Public Health. 2018 Apr 20;18(1):525. doi: 10.1186/s12889-018-5416-7.
- Results publication: PubMed 31041110Sahin C, Courtney KL, Naylor PJ, E Rhodes R. Tailored mobile text messaging interventions targeting type 2 diabetes self-management: A systematic review and a meta-analysis. Digit Health. 2019 Apr 22;5:2055207619845279. doi: 10.1177/2055207619845279. eCollection 2019 Jan-Dec.
- Results publication: PubMed 25745493Bin Abbas B, Al Fares A, Jabbari M, El Dali A, Al Orifi F. Effect of mobile phone short text messages on glycemic control in type 2 diabetes. Int J Endocrinol Metab. 2015 Jan 1;13(1):e18791. doi: 10.5812/ijem.18791. eCollection 2015 Jan.
- Results publication: PubMed 32477434Omar MA, Hasan S, Palaian S, Mahameed S. The impact of a self-management educational program coordinated through WhatsApp on diabetes control. Pharm Pract (Granada). 2020 Apr-Jun;18(2):1841. doi: 10.18549/PharmPract.2020.2.1841. Epub 2020 May 3.
- statistical figuresLink provided by the sponsor.
- statistical figuresLink provided by the sponsor.
- statistical figuresLink provided by the sponsor.
- SMS education for the promotion of diabetes self-management in low \& middle income countries: a pilot randomized controlled trial in EgyptLink provided by the sponsor.
- Effectiveness of diabetes self-management education (DSME) in type 2 diabetes mellitus (T2DM) patients: Systematic literature reviewLink provided by the sponsor.
- Educating diabetic patients through an SMS intervention: a randomized controlled trial at a Brazilian public hospitalLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Najla El Lakkis, FAM MED principal investigator
American University of Beirut Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Educational Text Messages in people with Diabetes Mellitus, run by American University of Beirut Medical Center.
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 19 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Najla El Lakkis, FAM MED (01-350000 ext. 3020, ne23@aub.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in glycemic control determined by HbA1C (in percent) in participants with diabetes pre and post intervention. (time frame: at 3 and 6 months interval). 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 NCT06176495, which also lists 7 linked publications.
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 5 Jan 2024.