An interventional study of Educational Text Messages in Diabetes Mellitus, sponsored by American University of Beirut Medical Center. Not yet recruiting. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-05.
Sponsored by American University of Beirut Medical Center · Not applicable, Interventional, and Prevention
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.
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.
10,926 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 200 is above the median of 80 across 8,368 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →American University of Beirut Medical Center is the lead sponsor of 152 studies on the registry; 27 are open to participants now.
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Inclusion Criteria for Participants with Diabetes:
Exclusion Criteria for participants with Diabetes:
Inclusion Criteria for Family Member Caregivers:
Patients with Diabetes and Family Member Caregivers who will receive no text messages over the designated period of the designated
Patients with Diabetes and Family Member Caregivers who will receive Educational Text Messages via WhatsApp over the designated period of the intervention
Diagnostic Test: Educational Text Messages
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.
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.
Time frame: at 3 and 6 months interval
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.
Time frame: 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.
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
Percentage change in weight (in kg), height ( in meters) and BMI (in Kg/m2) pre and post intervention in participants with diabetes
Time frame: 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
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
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
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)
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.
Time frame: 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.
Time frame: At 3 and 6 months interval
No study locations are listed for this record.
Plan to share: No
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American University of Beirut Medical Center