Clinical trial NCT04236206: Short Message Service for Type 2 Diabetes
Official title: Effectiveness of a Mobile Phone Short Message Service on Glycemic Control and Adherence to Treatment for Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes
Medication adherence
Telemedicine
mhealth
SMS
Lead sponsor: Alexandria University
Sponsor class: OTHER
Collaborators: name: High Institute of Public Health, Egypt
First posted: 2020-01-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Quasi-experimental; non-randomized, pre-test, post-test control group design.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Diabetes is a chronic disease where type 1 diabetes (T1D) is due to autoimmune ẞ-cell destruction, usually leading to absolute insulin deficiency, type 2 diabetes (T2D) is due to a progressive loss of ẞ-cell insulin secretion frequently on the background of insulin resistance. A third type-Gestational diabetes mellitus (GDM)-is diagnosed in the second or third trimester of pregnancy and was not clearly overt diabetes prior to gestation (American Diabetes Association. Lifestyle management can enhance diabetes care and it includes diabetes self-management education and support (DSMES), medical nutrition therapy, physical activity, smoking cessation counselling, and psychosocial care. However, health systems cannot control all the factors that influence a person's overall health, as physicians are unable to check regularly what their patients eat or whether they properly adhere to their medications. Pharmacists involved in DSMES can help patients achieve therapeutic and lifestyle goals. This active participation requires that the pharmacist's practice extend beyond the traditional role. Patients and care providers should work together to optimize lifestyle aspects through the entire care process. Telemedicine "healing at a distance" signifies the use of information and communication technology to improve patient outcomes by increasing access to care and medical information. Using mobile and wireless technologies to achieve health objectives (mHealth) can universally transform health services' delivery. Mobile phones can easily reach population since they have exceeded other communication technologies in Low and middle-Income countries (LMICs). The results of the present study will help the policy-makers in the MOHP to understand the importance of creating healthcare systems that meet the needs of patients and providers and develop DSMES strategy with the help of pharmacist educator and using innovative mobile phone technology.

Detailed description: The global prevalence of diabetes among adults aged over 18 years old has increased from 4.7% in 1980 to 8.5% in 2014 (Mathers \& Loncar, 2006; WHO, 2018b). The World Health Organization (WHO) estimates that diabetes was the seventh leading cause of death in 2016 (WHO, 2016; WHO, 2018a). Current national statistics show that around 17% of all Egyptian adults have diabetes, and over 60% of diabetics receive no treatment (Eastern Mediterranean Regional Office (EMRO), 2016). According to the WHO, there will be 6,726,000 cases of diabetes in Egypt by 2030 (WHO, 2000).

Almost 45% of patients with T2D cannot achieve adequate glycemic control (HbA1c \<7%). Poor medication adherence in T2D is a common public health problem and is associated with poor glycemic control, increased morbidity and mortality, and increased costs of outpatient care, emergency room visits, hospitalization, and managing complications of diabetes (Polonsky \& Henry, 2016).

Pharmacists involved in DSMES can help patients achieve therapeutic and lifestyle goals. This active participation requires that the pharmacist's practice extend beyond the traditional role (Shane-McWhorter et al., 2009). Patients and care providers should work together to optimize lifestyle aspects through the entire care process (Abaza \& Marschollek, 2017).

In Egypt, the Ministry of Health and Population (MOHP) is partially implementing diabetes education, mostly in outpatient clinics via educational meetings or counselling with physicians/ nurses. Patients often report difficulty sticking to healthy lifestyles. They are also liable to forget or ignore their physician's advice after leaving the clinic. Therefore, they need an educational method that can easily reach them to make knowledgeable patients and save the physician's critical time (Abaza \& Marschollek, 2017).

According to the Ministry of Communications and Information Technology (MCIT) in Egypt, up to October 2019, there were 95.25 million mobile subscriptions as opposed to 8.72 million fixed-line subscriptions (Ministry of Communication and Information Technology \[MCIT\], 2019). Moreover, there were 38.67 million mobile internet users versus 7.17 million Asymmetric Digital Subscriber Line subscriptions in the same month; the mobile internet users could reflect the proportion of smartphone owners in the country (MCIT, 2019). In contrary to mobile internet or smartphone applications, short message service (SMS) can provide a simple way of communication reaching a larger population since almost all types of mobile phones support them (Abaza \& Marschollek, 2017).

Eligibility criteria: Inclusion Criteria:

* Age: 18 years old and more.
* Diagnosed with T2D up to 15 years according to the American Diabetes Association (ADA) standards (ADA, 2018).
* With poorly controlled diabetes, (pre-intervention HbA1c values of 7% up to 10%).
* Registered in the selected primary health care (PHC) centers and living in Alexandria.
* Currently on oral medication therapy (if purchased from the center pharmacy) and able to afford the cost for 6 months treatment (if purchased from an external pharmacy).
* Has a personal mobile phone.
* Know how to retrieve/read SMS on the mobile phone (Arabic alphabets).
* Available for the study duration.

Exclusion Criteria:

* Patients with clinical conditions that might interfere with the study such as pregnancy, mental illness, poor eyesight, hearing or vocalization, visual, renal or liver impairment, other serious illness or co-morbidities requiring hospitalization.

Primary outcomes:
measure: Glycemic Control
timeFrame: Change from Baseline HbA1c level at 6 months.
Secondary outcomes:
measure: Medication Adherence
timeFrame: Change from Baseline Medication Adherence at 6 months.
Other outcomes:
measure: Diabetes-related Knowledge
timeFrame: Change from Baseline Diabetes-related Knowledge at 6 months.
Locations:
city: Alexandria
country: Egypt
facility: Family Health Centers
Study officials:
affiliation: High Institute of Public Health, Alexandria University
name: Rehab A Rayan, PharmD
role: PRINCIPAL_INVESTIGATOR
References: