The Effects of Short Message Notifications on Middle-Aged Diabetic Patients
- Conditions
- Type2 Diabetes Mellitus
- Interventions
- Other: Informative messages
- Registration Number
- NCT04733612
- Lead Sponsor
- Istanbul University
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 125
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SMS Group Informative messages In addition to traditional treatment received three to four informative SMS messages per week during the 6-month period
- Primary Outcome Measures
Name Time Method Fasting blood glucose Beginning After 8 hours of fasting in the morning, venous whole blood samples were taken to yellow capped tubes for fasting blood glucose (mmol/dL).
Change from Baseline Fasting blood glucose at 3 months 3 months after beginning After 8 hours of fasting in the morning, venous whole blood samples were taken to yellow capped tubes for fasting blood glucose (mmol/dL).
Glycated hemoglobin A (HbA1c) Beginning 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.
Change from Baseline Physical Activity at 3 months 3 months from beginning 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.Change from Baseline Drug Adherence at 6 months 6 months after beginning 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.Change from Baseline Quality of Life Assessed by SF-36v2 at 3 months 3 months after beginning 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.
Change from Baseline of Glycated hemoglobin A (HbA1c) at 3 months 3 months after beginning 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
Physical Activity level Beginning 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.Change from Baseline Fasting blood glucose at 6 months 6 months after beginning After 8 hours of fasting in the morning, venous whole blood samples were taken to yellow capped tubes for fasting blood glucose (mmol/dL).
Change from Baseline of Glycated hemoglobin A (HbA1c) at 6 months 6 months after beginning 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
Change from Baseline Physical Activity at 6 months 6 months from beginning 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.Drug Adherence Beginning 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.Change from Baseline Drug Adherence at 3 months 3 months after beginning 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.Quality of Life Assessed by SF-36v2 Beginning 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.
Change from Baseline Quality of Life Assessed by SF-36v2 at 6 months 6 months after beginning 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.
- Secondary Outcome Measures
Name Time Method Baseline heart rate Beginning 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.
Baseline blood pressure Beginning 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.
Change from Baseline blood pressure at 3 months 3 months after beginning 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.
Change from Baseline heart rate at 3 months 3 Months After Beginning 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.
Change from Baseline Body Mass Index at 6 months 6 months after Beginning 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.Change from Baseline blood pressure at 6 months 6 months after beginning 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.
Change from Baseline heart rate at 6 months 6 Months After Beginning 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.
Baseline body fat ratios Beginning 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.
Baseline Body Mass Index Beginning 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.Change from Baseline Body Mass Index at 3 months 3 months after Beginning 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.Change from Baseline Diet and Nutritional Habits at 6 months 6 Months after Beginning 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.
Change from Baseline Body Fat Ratios at 3 Months 3 Months After Beginning 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.
Change from Baseline waist/hip ratio at 3 Months 3 Months after Beginning 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 circumferenceBaseline Energy Intake Beginning From the last three days' food intake form the average calories (kcal) of macro and micronutrients are calculated.
Change from Baseline Energy Intake at 3 months 3 months after Beginning From the last three days' food intake form the average calories (kcal) of macro and micronutrients are calculated.
Change from Baseline Body Fat Ratios at 6 Months 6 Months After Beginning 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.
Baseline waist/hip ratio Beginning 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 circumferenceBaseline Diet and Nutritional Habits Beginning 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.
Change from Baseline Diet and Nutritional Habits at 3 months 3 Months after Beginning 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.
Change from Baseline Energy Intake at 6 months 6 months after Beginning From the last three days' food intake form the average calories (kcal) of macro and micronutrients are calculated.