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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06176495
• Other study ID #: SBS-2023-0225
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: November 2024

Study information

• Verified date: December 2023
• Source: American University of Beirut Medical Center
• Contact: Najla El Lakkis, FAM MED
• Phone: 01-350000
• Email: ne23[@]aub.edu.lb
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 American University of Beirut Health Insurance Plan (AUB-HIP)

• 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

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; Human immunodeficiency virus infection and Acquired immune deficiency syndrome 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

Related Conditions & MeSH terms

• Diabetes Mellitus

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
American University of Beirut Medical Center

References & Publications (7)

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. — View Citation

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. — View Citation

Bin 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. — View Citation

Ernawati 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. — View Citation

Karaoui 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. — View Citation

Omar 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. — View Citation

Sahin 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. eCol — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	at 3 and 6 months interval
Secondary	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.	at 3 and 6 months interval
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.	At 3 and 6 months interval
Secondary	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.	At 3 and 6 months interval

External Links

•   Disease-related distress, self-care and clinical outcomes among low-income patients with diabetes
•   Educating diabetic patients through an SMS intervention: a randomized controlled trial at a Brazilian public hospital
•   Effect of Mobile Phone Short Text Messages on Glycemic Control in Type 2 Diabetes
•   Effectiveness of diabetes self-management education (DSME) in type 2 diabetes mellitus (T2DM) patients: Systematic literature review
•   Effects of Patient-Driven Lifestyle Modification Using Intermittently Scanned Continuous Glucose Monitoring in Patients With Type 2 Diabetes: Results From the Randomized Open-label Study
•   Family-Centered Diabetes Care for Better Glycemic Outcomes of Outpatients in Rural Areas
•   Knowledge and practice of patients with diabetes mellitus in Lebanon: a cross-sectional study
•   Level of knowledge, attitude and practice towards diabetes among nationals and long-term residents of Qatar: a cross-sectional study (With KAP Questionnaire)
•   SMS education for the promotion of diabetes self-management in low & middle income countries: a pilot randomized controlled trial in Egypt
•   statistical figures
•   statistical figures
•   statistical figures
•   Tailored mobile text messaging interventions targeting type 2 diabetes self-management: A systematic review and a meta-analysis
•   The impact of a self-management educational program coordinated through WhatsApp on diabetes control