Short Message Service for Type 2 Diabetes

NCT04236206 | Completed DMC

• 1 other identifier: RR-SMS4T2D-2020
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes; Medication adherence; Telemedicine; mhealth; SMS

Outcome Measures

Primary Outcomes (1)

• Glycemic Control

  To assess the effect of the intervention on patients with type 2 diabetes in terms of glycemic control (HbA1c level).

  Change from Baseline HbA1c level at 6 months.

Secondary Outcomes (1)

• Medication Adherence

  Change from Baseline Medication Adherence at 6 months.

Other Outcomes (1)

• Diabetes-related Knowledge

  Change from Baseline Diabetes-related Knowledge at 6 months.

Study Arms (2)

SMS Recipients

EXPERIMENTAL

• Mobile phone SMSs will be sent to the intervention group with the aim of improving medication adherence and knowledge about diabetes, its complications, diet and physical activity.

Behavioral: Mobile Phone Short Message Service

Non-SMS Recipients

NO INTERVENTION

Control group with no intervention.

Interventions

Mobile Phone Short Message Service BEHAVIORAL

SMS content will be adopted from the validated Arabic national and international diabetes educational materials (Centers for Disease Control (CDC), 2018; Diabetes Australia, 2004; Diabetes Queensland, 2012; Utah Diabetes Control Program, 2005). * The mobile phone SMSs will be pre-tested for clarity on a sample of 10 patients similar to the study population and their comments on the SMSs wording will be used to modify them to ensure acceptance. * The SMS will be sent to participants using the internet, open-source software for bulk messages and a local telephone network provider. * Patients will be encouraged to send messages/call the researcher for any queries encountered.

SMS Recipients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead
• High Institute of Public Health, Egypt: collaborator

Study Sites (1)

Family Health Centers

Alexandria, 21500, Egypt

Location

Related Links

• SMS education for the promotion of diabetes self-management in low \& middle-income countries: a pilot randomized controlled trial in Egypt.
• G\*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences.
• mHealth interventions to counter noncommunicable diseases in developing countries: still an uncertain promise.
• Effectiveness of mobile phone short message service on diabetes mellitus management; the SMS-DM study.
• Projections of global mortality and burden of disease from 2002 to 2030.
• Use of mHealth systems and tools for non-communicable diseases in low- and middle-income Countries: a systematic review.
• Poor medication adherence in type 2 diabetes: recognizing the scope of the problem and its key contributors.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Medication Adherence

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Rehab A Rayan, PharmD

  High Institute of Public Health, Alexandria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Researcher in the Department of Epidemiology, High Institute of Public Health

Model Details: Quasi-experimental; non-randomized, pre-test, post-test control group design.

Study Record Dates

• First Submitted: January 13, 2020
• First Posted: January 22, 2020
• Study Start: October 1, 2020
• Primary Completion: March 30, 2021
• Study Completion: April 10, 2021
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)