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

Type2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04733612
• Other study ID #: 20135
• Status: Completed
• Phase: N/A
• Start date: June 30, 2016
• Est. completion date: February 26, 2018

Study information

• Verified date: January 2021
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: February 26, 2018
• Est. primary completion date: December 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Baseline Energy Intake	From the last three days' food intake form the average calories (kcal) of macro and micronutrients are calculated.	Beginning
Secondary	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
Secondary	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