Empowering Patients With Diabetes and Their Family Members: Assessing the Impact of Free Informative Mobile Messages

Study Overview
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Brief Summary
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This is a RCT 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
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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 particpants, 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.

Official Title
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Empowering Patients With Diabetes and Their Family Members: Assessing the Impact of Free Informative Mobile Messages

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Diagnostic Test: Educational Text Messages


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for Participants with Diabetes: 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 AUB Health Insurance Plan (AUB-HIP) Patients who have visited the Family Medicine Primary Care Clinics at AUBMC 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 Exclusion Criteria for participants with Diabetes: 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; HIV/AIDs and etc.) 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 Inclusion Criteria for Family Member Caregivers: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Patients with Diabetes and Family Member Caregivers who will receive no text messages over the designated period of the designated | |
| Other: Intervention Group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | at 3 and 6 months interval | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | at 3 and 6 months interval | 
| Assessment of Changes in Mood score (in percentage pre and post intervention) | Changes in patients' mood and mental heath (anxiety and depression) pre and post intervention using the GAD 2 and PHQ 2 scaled scores. this will be reflected in percentage (pre and post intervention) to reflect the changes in the participants' mood. | 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 | 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 | 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 | 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 | At 3 and 6 months interval | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Family Member Caregivers, Education, Educational text messages, WhatsApp