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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 125
- 主要终点
- Fasting blood glucose
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Fasting blood glucose
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Baseline heart rate(Beginning)
- Baseline blood pressure(Beginning)
- Change from Baseline blood pressure at 3 months(3 months after beginning)
- Change from Baseline heart rate at 3 months(3 Months After Beginning)
- Change from Baseline Body Mass Index at 6 months(6 months after Beginning)
- Change from Baseline blood pressure at 6 months(6 months after beginning)
- Change from Baseline heart rate at 6 months(6 Months After Beginning)
- Baseline body fat ratios(Beginning)
- Baseline Body Mass Index(Beginning)
- Change from Baseline waist/hip ratio at 3 Months(3 Months after Beginning)
- Change from Baseline Body Mass Index at 3 months(3 months after Beginning)
- Change from Baseline Diet and Nutritional Habits at 6 months(6 Months after Beginning)
- Change from Baseline Body Fat Ratios at 3 Months(3 Months After Beginning)
- Baseline Energy Intake(Beginning)
- Change from Baseline Energy Intake at 3 months(3 months after Beginning)
- Change from Baseline Body Fat Ratios at 6 Months(6 Months After Beginning)
- Baseline waist/hip ratio(Beginning)
- Baseline Diet and Nutritional Habits(Beginning)
- Change from Baseline Diet and Nutritional Habits at 3 months(3 Months after Beginning)
- Change from Baseline Energy Intake at 6 months(6 months after Beginning)
研究者
Bernard Tahirbegolli
Principal Investigator
Istanbul University