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

January 3, 2024 updated by: Najla El Lakkis, American University of Beirut Medical Center

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Najla El Lakkis, FAM MED
  • Phone Number: 3020 01-350000
  • Email: ne23@aub.edu.lb

Study Contact Backup

  • Name: Farah Farhat, MD
  • Phone Number: 3020 01-350000
  • Email: ff38@aub.ed.lb

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

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.
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.
at 3 and 6 months interval

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 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
Time Frame: 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
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
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
Percentage change in systolic and diastolic blood pressure (in mmHg) in participants with diabetes pre and post intervention
At 3 and 6 months interval
Change in knowledge before and after the intervention (in percentage)
Time Frame: at 3 and 6 months interval

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
Changes in Daily Health Practices pre and post intervention (in percentage)
Time Frame: at 3 and 6 months interval

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
Assessment of Changes in Depression Screening score (in percentage pre and post intervention)
Time Frame: At 3 and 6 months interval

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
Assessment of Changes in Anxiety Screening score (in percentage pre and post intervention)
Time Frame: At 3 and 6 months interval

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American University of Beirut Medical Center

Investigators

  • Principal Investigator: Najla El Lakkis, FAM MED, American University of Beirut Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

November 21, 2023

First Submitted That Met QC Criteria

December 9, 2023

First Posted (Actual)

December 19, 2023

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 3, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBS-2023-0225

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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