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Short Message Service for Type 2 Diabetes (SMS4T2D)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Mobile Phone Short Message Service
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes, Medication adherence, Telemedicine, mhealth, SMS

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Family Health Centers

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SMS Recipients

Non-SMS Recipients

Arm Description

• 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.

Control group with no intervention.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Medication Adherence
To assess the effect of the intervention on patients with type 2 diabetes in terms of adherence to the prescribed hypoglycemic medications using the short form of adherence to refills and medications scale (ARMS-SF).

Full Information

First Posted
January 13, 2020
Last Updated
July 19, 2022
Sponsor
Alexandria University
Collaborators
High Institute of Public Health, Egypt
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1. Study Identification

Unique Protocol Identification Number
NCT04236206
Brief Title
Short Message Service for Type 2 Diabetes
Acronym
SMS4T2D
Official Title
Effectiveness of a Mobile Phone Short Message Service on Glycemic Control and Adherence to Treatment for Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
March 30, 2021 (Actual)
Study Completion Date
April 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University
Collaborators
High Institute of Public Health, Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Diabetes, Medication adherence, Telemedicine, mhealth, SMS

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Quasi-experimental; non-randomized, pre-test, post-test control group design.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SMS Recipients
Arm Type
Experimental
Arm Description
• 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.
Arm Title
Non-SMS Recipients
Arm Type
No Intervention
Arm Description
Control group with no intervention.
Intervention Type
Behavioral
Intervention Name(s)
Mobile Phone Short Message Service
Intervention Description
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.
Primary Outcome Measure Information:
Title
Glycemic Control
Description
To assess the effect of the intervention on patients with type 2 diabetes in terms of glycemic control (HbA1c level).
Time Frame
Change from Baseline HbA1c level at 6 months.
Secondary Outcome Measure Information:
Title
Medication Adherence
Description
To assess the effect of the intervention on patients with type 2 diabetes in terms of adherence to the prescribed hypoglycemic medications using the short form of adherence to refills and medications scale (ARMS-SF).
Time Frame
Change from Baseline Medication Adherence at 6 months.
Other Pre-specified Outcome Measures:
Title
Diabetes-related Knowledge
Description
To assess the effect of the intervention on patients with type 2 diabetes in terms of diabetes-related knowledge (the disease symptoms, its complications, tests, importance of medication adherence, diet, physical activity and regular care) using a predesigned structured interviewing questionnaire.
Time Frame
Change from Baseline Diabetes-related Knowledge at 6 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rehab A Rayan, PharmD
Organizational Affiliation
High Institute of Public Health, Alexandria University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Family Health Centers
City
Alexandria
ZIP/Postal Code
21500
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://dx.doi.org/10.1186%2Fs12889-017-4973-5
Description
SMS education for the promotion of diabetes self-management in low & middle-income countries: a pilot randomized controlled trial in Egypt.
URL
https://doi.org/10.2337/dc20-Sint
Description
Standards of Medical Care in Diabetes-2020
URL
https://doi.org/10.3758/BF03193146
Description
G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences.
URL
https://doi.org/10.1016/j.ccl.2016.08.009
Description
mHealth interventions to counter noncommunicable diseases in developing countries: still an uncertain promise.
URL
https://doi.org/10.1016/j.diabres.2011.07.025
Description
Effectiveness of mobile phone short message service on diabetes mellitus management; the SMS-DM study.
URL
https://doi.org/10.2337/dc15-0505
Description
Effects of mobile phone SMS to improve glycemic control among patients with type 2 diabetes in Bangladesh: a prospective, parallel-group, randomized controlled trial.
URL
https://doi.org/10.1371/journal.pmed.0030442
Description
Projections of global mortality and burden of disease from 2002 to 2030.
URL
https://doi.org/10.1007/s12265-014-9581-5
Description
Use of mHealth systems and tools for non-communicable diseases in low- and middle-income Countries: a systematic review.
URL
https://doi.org/10.2147/PPA.S106821
Description
Poor medication adherence in type 2 diabetes: recognizing the scope of the problem and its key contributors.

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Short Message Service for Type 2 Diabetes

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