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

NCT06176495 | Unknown DMC

• 1 other identifier: SBS-2023-0225
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Diabetes Mellitus

Keywords

Diabetes Mellitus; Family Member Caregivers; Education; Educational text messages; WhatsApp

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Change in knowledge before and after the intervention (in percentage)

  at 3 and 6 months interval

• Changes in Daily Health Practices pre and post intervention (in percentage)

  at 3 and 6 months interval

• Percentage change in weight (in Kg), height (in meters) and BMI (Kg/m2) pre and post intervention

  At 3 and 6 months interval

• 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

  At 3 and 6 months interval

Study Arms (2)

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

Diagnostic Test: Educational Text Messages

Interventions

Educational Text Messages DIAGNOSTIC_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.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Related Publications (7)

• 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.

  PMID: 35172997 BACKGROUND

• 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.

  PMID: 29258499 RESULT

• 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.

  PMID: 33855427 RESULT

• 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.

  PMID: 29678148 RESULT

• 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. eCollection 2019 Jan-Dec.

  PMID: 31041110 RESULT

• 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.

  PMID: 25745493 RESULT

• 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.

  PMID: 32477434 RESULT

Related Links

• statistical figures
• statistical figures
• statistical figures
• SMS education for the promotion of diabetes self-management in low \& middle income countries: a pilot randomized controlled trial in Egypt
• Effectiveness of diabetes self-management education (DSME) in type 2 diabetes mellitus (T2DM) patients: Systematic literature review
• Educating diabetic patients through an SMS intervention: a randomized controlled trial at a Brazilian public hospital
• 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)
• Disease-related distress, self-care and clinical outcomes among low-income patients with diabetes
• Family-Centered Diabetes Care for Better Glycemic Outcomes of Outpatients in Rural Areas
• Tailored mobile text messaging interventions targeting type 2 diabetes self-management: A systematic review and a meta-analysis
• Effect of Mobile Phone Short Text Messages on Glycemic Control in Type 2 Diabetes
• The impact of a self-management educational program coordinated through WhatsApp on diabetes control

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Najla El Lakkis, FAM MED

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Najla El Lakkis, FAM MED

CONTACT

01-350000; ne23@aub.edu.lb

Farah Farhat, MD

CONTACT

01-350000; ff38@aub.ed.lb

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist in Family Medicine; Specialist in Occupational Medicine; Clinical Associate in Family Medicine

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: December 19, 2023
• Study Start: January 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: January 5, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share