The Effects of Short Message Notifications on Middle-Aged Diabetic Patients

Effects of Short-Message Notifications on Medication Adherence, Physical Activity and Fasting Blood Glucose Control and Correlation of These With the Health-Related Quality of Life in Mid-aged Diabetic Patients

The objective of our study was to assess awareness-raising of medication adherence (MA), physical activity (PA), fasting blood glucose (FBG), and glycated hemoglobin A (HbA1c) values by providing information on diabetes via short message (SMS) technology.

Study Overview

• Status: Completed
• Conditions: Type2 Diabetes Mellitus
• Intervention / Treatment: Other: Informative messages

Detailed Description

The study investigates T2DM patients who have not had surgery or cardiac event in the last 3 months, between the ages of 40 and 64 years, with T2DM diagnosis between the last 1 and 10 years and oral antidiabetic therapy for at least 1 The study design is a single-blinded randomized, controlled study, and was conducted in the Diabetes Polyclinic of the Istanbul University Medical Faculty Hospital.

Patients randomly assigned to the intervention group, in addition to traditional treatment received three to four informative SMS messages per week during the 6-month period, while the control group was followed in accordance with the traditional treatment schedule.

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical diagnosis of Type 2 Diabetes Mellitus (T2DM) between the last 1 and 10 years
• Being aged between 40 and 64 years old,
• Is treated for a minimum of 1 year with at least one oral antidiabetic drug.

Exclusion Criteria:

• Clinical diagnosis of T2DM for less than 1 year or more than 10 years.
• Those who have had surgery or a cardiac event in the last 3 months or during the investigation.
• Those under 40 and over 64 years of age.
• Patients with T2DM that have not been treated with oral antidiabetic medication.
• Volunteers who once did not participate in the control examinations in both groups were excluded from the evaluation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SMS Group; In addition to traditional treatment received three to four informative SMS messages per week during the 6-month period	Other: Informative messages; In addition to their standard treatments, an informative SMS (text message) on diabetes was sent to the intervention group three to four times a week for six months. The short messages were in the form of a short sentence for the subject and the predicate. The messages sent have been prepared in such a way that they do not exceed 1 SMS quota and are less than 160 characters on mobile phones.
No Intervention: Control Group; Followed in accordance with the traditional treatment schedule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting blood glucose	After 8 hours of fasting in the morning, venous whole blood samples were taken to yellow capped tubes for fasting blood glucose (mmol/dL).	Beginning
Change from Baseline Fasting blood glucose at 3 months	After 8 hours of fasting in the morning, venous whole blood samples were taken to yellow capped tubes for fasting blood glucose (mmol/dL).	3 months after beginning
Change from Baseline Fasting blood glucose at 6 months	After 8 hours of fasting in the morning, venous whole blood samples were taken to yellow capped tubes for fasting blood glucose (mmol/dL).	6 months after beginning
Glycated hemoglobin A (HbA1c)	In the HbA1c evaluation (%), after 8 hours of fasting by volunteers, venous whole blood samples were taken in purple tubes (EDTA) between 08:00 and 10:00 a.m. and evaluated by the HPLC method.	Beginning
Change from Baseline of Glycated hemoglobin A (HbA1c) at 3 months	In the HbA1c evaluation (%), after 8 hours of fasting by volunteers, venous whole blood samples were taken in purple tubes (EDTA) between 08:00 and 10:00 a.m. and evaluated by the HPLC method	3 months after beginning
Change from Baseline of Glycated hemoglobin A (HbA1c) at 6 months	In the HbA1c evaluation (%), after 8 hours of fasting by volunteers, venous whole blood samples were taken in purple tubes (EDTA) between 08:00 and 10:00 a.m. and evaluated by the HPLC method	6 months after beginning
Physical Activity level	The International Physical Activity Questionnaire (IPAQ) was used to evaluate the physical activity level of the participants at the beginning of the study. This measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting. The higher scores mean a better outcome.	Beginning
Change from Baseline Physical Activity at 3 months	The International Physical Activity Questionnaire (IPAQ) was used to evaluate the physical activity level of the participants at at 3 months after the beginning of the study. This measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting. The higher scores mean a better outcome.	3 months from beginning
Change from Baseline Physical Activity at 6 months	The International Physical Activity Questionnaire (IPAQ) was used to evaluate the change in physical activity level of the participants at at 6 months after the beginning of the study. This measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting. The higher scores mean a better outcome.	6 months from beginning
Drug Adherence	The Morisky Medication Adherence Scale (MMAS-8) was used to assess the compliance of patients with drug treatment. If the patient scores higher on the scale, they will be assessed as more adherent. If they score lower on the scale, they are presumed to be struggling with non-adherence.	Beginning
Change from Baseline Drug Adherence at 3 months	The Morisky Medication Adherence Scale was used to assess the compliance of patients with drug treatment. If the patient scores higher on the scale, they will be assessed as more adherent. If they score lower on the scale, they are presumed to be struggling with non-adherence.	3 months after beginning
Change from Baseline Drug Adherence at 6 months	The Morisky Medication Adherence Scale (MMAS-8) was used to assess the compliance of patients with drug treatment. If the patient scores higher on the scale, they will be assessed as more adherent. If they score lower on the scale, they are presumed to be struggling with non-adherence.	6 months after beginning
Quality of Life Assessed by SF-36v2	The Short-Form Health Survey (SF-36v2) is used to asses the quality of life of volunteers'. It has 36 items grouped in 8 dimensions: physical functioning, physical and emotional limitations, social functioning, bodily pain, general and mental health. The higher scores mean a better outcome.	Beginning
Change from Baseline Quality of Life Assessed by SF-36v2 at 3 months	The Short-Form Health Survey (SF-36v2) is used to asses the quality of life of volunteers'. It has 36 items grouped in 8 dimensions: physical functioning, physical and emotional limitations, social functioning, bodily pain, general and mental health. The higher scores mean a better outcome.	3 months after beginning
Change from Baseline Quality of Life Assessed by SF-36v2 at 6 months	The Short-Form Health Survey (SF-36v2) is used to asses the quality of life of volunteers'. It has 36 items grouped in 8 dimensions: physical functioning, physical and emotional limitations, social functioning, bodily pain, general and mental health. The higher scores mean a better outcome.	6 months after beginning

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline blood pressure	The volunteers' systolic and diastolic blood pressure (mmHg) was measured by a physician through a manual cuff and stethoscope after sitting for at least 5 minutes, from the left arm at the level of the heart, as suggested in the literature.	Beginning
Change from Baseline blood pressure at 3 months	The volunteers' systolic and diastolic blood pressure (mmHg) was measured by a physician through a manual cuff and stethoscope after sitting for at least 5 minutes, from the left arm at the level of the heart, as suggested in the literature.	3 months after beginning
Change from Baseline blood pressure at 6 months	The volunteers' systolic and diastolic blood pressure (mmHg) was measured by a physician through a manual cuff and stethoscope after sitting for at least 5 minutes, from the left arm at the level of the heart, as suggested in the literature.	6 months after beginning
Baseline heart rate	The volunteers' heart rate count was measured by a finger-type pulse oximeter, from the index finger of the right or left hand after resting for at least 5 minutes.	Beginning
Change from Baseline heart rate at 3 months	The volunteers' heart rate count was measured by a finger-type pulse oximeter, from the index finger of the right or left hand after resting for at least 5 minutes.	3 Months After Beginning
Change from Baseline heart rate at 6 months	The volunteers' heart rate count was measured by a finger-type pulse oximeter, from the index finger of the right or left hand after resting for at least 5 minutes.	6 Months After Beginning
Baseline Body Mass Index	The height (cm) of the volunteers was obtained in the morning, after 8 hours of fasting, without shoes, standing upright, by measuring the distance from the top of the head to the floor with a calibrated stadiometer. Body weight (kg) were measured in the morning after 8 hours of fasting, with light clothing and bare feet, with a calibrated and valid 'Tanita Body Composition Analyzer TBF-410GS' brand bioelectrical impedance analyzer. Body Mass Index (BMI) is calculated using a person's height and weight as shown in formula: BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in meter square.	Beginning
Change from Baseline Body Mass Index at 3 months	The height (cm) of the volunteers was obtained in the morning, after 8 hours of fasting, without shoes, standing upright, by measuring the distance from the top of the head to the floor with a calibrated stadiometer. Body weight (kg) were measured in the morning after 8 hours of fasting, with light clothing and bare feet, with a calibrated and valid 'Tanita Body Composition Analyzer TBF-410GS' brand bioelectrical impedance analyzer. Body Mass Index (BMI) is calculated using a person's height and weight as shown in formula: BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in meter square.	3 months after Beginning
Change from Baseline Body Mass Index at 6 months	The height (cm) of the volunteers was obtained in the morning, after 8 hours of fasting, without shoes, standing upright, by measuring the distance from the top of the head to the floor with a calibrated stadiometer. Body weight (kg) were measured in the morning after 8 hours of fasting, with light clothing and bare feet, with a calibrated and valid 'Tanita Body Composition Analyzer TBF-410GS' brand bioelectrical impedance analyzer. Body Mass Index (BMI) is calculated using a person's height and weight as shown in formula: BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in meter square.	6 months after Beginning
Baseline body fat ratios	The body fat ratios were measured in the morning after 8 hours of fasting, with light clothing and bare feet, with a calibrated and valid 'Tanita Body Composition Analyzer TBF-410GS' brand bioelectrical impedance analyzer.	Beginning
Change from Baseline Body Fat Ratios at 3 Months	The body fat ratios were measured in the morning after 8 hours of fasting, with light clothing and bare feet, with a calibrated and valid 'Tanita Body Composition Analyzer TBF-410GS' brand bioelectrical impedance analyzer.	3 Months After Beginning
Change from Baseline Body Fat Ratios at 6 Months	The body fat ratios were measured in the morning after 8 hours of fasting, with light clothing and bare feet, with a calibrated and valid 'Tanita Body Composition Analyzer TBF-410GS' brand bioelectrical impedance analyzer.	6 Months After Beginning
Baseline waist/hip ratio	The volunteers waist and hip circumference and waist/hip ratio were measured by tape measure after 8 hours of fasting in the morning with thin clothes on them. Waist circumference (cm) was measured at the level of the umbilicus and hip circumference (cm) at the level of the femur trochanter major. Waist/hip ratio (WHR) were were calculated as follows waist/hip ratio= waist circumference / hip circumference	Beginning
Change from Baseline waist/hip ratio at 3 Months	The volunteers waist and hip circumference and waist/hip ratio were measured by tape measure after 8 hours of fasting in the morning with thin clothes on them. Waist circumference (cm) was measured at the level of the umbilicus and hip circumference (cm) at the level of the femur trochanter major. Waist/hip ratio (WHR) were were calculated as follows waist/hip ratio= waist circumference / hip circumference	3 Months after Beginning
Baseline Diet and Nutritional Habits	The last three days' food intake form is used to collect the information about daily nutritional habits of volunteers'. The amount of food and the frequency are marked.	Beginning
Change from Baseline Diet and Nutritional Habits at 3 months	The last three days' food intake form is used to collect the information about daily nutritional habits of volunteers'. The amount of food and the frequency are marked.	3 Months after Beginning
Change from Baseline Diet and Nutritional Habits at 6 months	The last three days' food intake form is used to collect the information about daily nutritional habits of volunteers'. The amount of food and the frequency are marked.	6 Months after Beginning
Baseline Energy Intake	From the last three days' food intake form the average calories (kcal) of macro and micronutrients are calculated.	Beginning
Change from Baseline Energy Intake at 3 months	From the last three days' food intake form the average calories (kcal) of macro and micronutrients are calculated.	3 months after Beginning
Change from Baseline Energy Intake at 6 months	From the last three days' food intake form the average calories (kcal) of macro and micronutrients are calculated.	6 months after Beginning

Collaborators and Investigators

• Sponsor: Istanbul University
• Investigators: Study Chair: Suphi Vehid, Prof. Dr., Istanbul University

Publications and helpful links

General Publications

• Tahirbegolli B, Tahirbegolli IA, Cakmak R, Idiz C, Cavdar S, Bagdemir E, Vehid S. Effects of Short-message Notifications on Type 2 Diabetes Management in Middle-aged Turkish Patients: A Randomized Trial. Balkan Med J. 2022 Mar 14;39(2):161-162. doi: 10.4274/balkanmedj.galenos.2021.2021-10-47. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2016
• Primary Completion (Actual): December 20, 2017
• Study Completion (Actual): February 26, 2018

Study Registration Dates

• First Submitted: January 16, 2021
• First Submitted That Met QC Criteria: January 28, 2021
• First Posted (Actual): February 2, 2021

Study Record Updates

• Last Update Posted (Actual): February 2, 2021
• Last Update Submitted That Met QC Criteria: January 28, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Diabetes mellitus; Public health
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 20135

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Since the start date of the study is before 18 January 2017, individual participant data (IPD) will only be available to other researchers on a reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No