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Completed

NCT Number: NCT04733612

The Effects of Short Message Notifications on Middle-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.

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Key information

Conditions

Type2 Diabetes Mellitus Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Informative messages

Other

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.

Primary outcomes

  1. Fasting blood glucose

    Time frame: 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).

  2. Change from Baseline Fasting blood glucose at 3 months

    Time frame: 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).

  3. Change from Baseline Fasting blood glucose at 6 months

    Time frame: 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).

  4. Glycated hemoglobin A (HbA1c)

    Time frame: 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.

  5. Change from Baseline of Glycated hemoglobin A (HbA1c) at 3 months

    Time frame: 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

  6. Change from Baseline of Glycated hemoglobin A (HbA1c) at 6 months

    Time frame: 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

  7. Physical Activity level

    Time frame: 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.

  8. Change from Baseline Physical Activity at 3 months

    Time frame: 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.

  9. Change from Baseline Physical Activity at 6 months

    Time frame: 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.

  10. Drug Adherence

    Time frame: 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.

  11. Change from Baseline Drug Adherence at 3 months

    Time frame: 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.

  12. Change from Baseline Drug Adherence at 6 months

    Time frame: 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.

  13. Quality of Life Assessed by SF-36v2

    Time frame: 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.

  14. Change from Baseline Quality of Life Assessed by SF-36v2 at 3 months

    Time frame: 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.

  15. Change from Baseline Quality of Life Assessed by SF-36v2 at 6 months

    Time frame: 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 outcomes

  1. Baseline blood pressure

    Time frame: 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.

  2. Change from Baseline blood pressure at 3 months

    Time frame: 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.

  3. Change from Baseline blood pressure at 6 months

    Time frame: 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.

  4. Baseline heart rate

    Time frame: 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.

  5. Change from Baseline heart rate at 3 months

    Time frame: 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.

  6. Change from Baseline heart rate at 6 months

    Time frame: 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.

  7. Baseline Body Mass Index

    Time frame: 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.

  8. Change from Baseline Body Mass Index at 3 months

    Time frame: 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.

  9. Change from Baseline Body Mass Index at 6 months

    Time frame: 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.

  10. Baseline body fat ratios

    Time frame: 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.

  11. Change from Baseline Body Fat Ratios at 3 Months

    Time frame: 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.

  12. Change from Baseline Body Fat Ratios at 6 Months

    Time frame: 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.

  13. Baseline waist/hip ratio

    Time frame: 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 circumference

  14. Change from Baseline waist/hip ratio at 3 Months

    Time frame: 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 circumference

  15. Baseline Diet and Nutritional Habits

    Time frame: 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.

  16. Change from Baseline Diet and Nutritional Habits at 3 months

    Time frame: 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.

  17. Change from Baseline Diet and Nutritional Habits at 6 months

    Time frame: 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.

  18. Baseline Energy Intake

    Time frame: Beginning

    From the last three days' food intake form the average calories (kcal) of macro and micronutrients are calculated.

  19. Change from Baseline Energy Intake at 3 months

    Time frame: 3 months after Beginning

    From the last three days' food intake form the average calories (kcal) of macro and micronutrients are calculated.

  20. Change from Baseline Energy Intake at 6 months

    Time frame: 6 months after Beginning

    From the last three days' food intake form the average calories (kcal) of macro and micronutrients are calculated.

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Feb 2, 2021
Registry last updated
Feb 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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