Clinical trial NCT04733612: The Effects of Short Message Notifications on Middle-Aged Diabetic Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes Mellitus
Keywords: Diabetes mellitus
Public health
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2021-02-02
Enrollment: 125
Sex: ALL
Minimum age (years): 40
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fasting blood glucose
timeFrame: Beginning
measure: Change from Baseline Fasting blood glucose at 3 months
timeFrame: 3 months after beginning
measure: Change from Baseline Fasting blood glucose at 6 months
timeFrame: 6 months after beginning
measure: Glycated hemoglobin A (HbA1c)
timeFrame: Beginning
measure: Change from Baseline of Glycated hemoglobin A (HbA1c) at 3 months
timeFrame: 3 months after beginning
measure: Change from Baseline of Glycated hemoglobin A (HbA1c) at 6 months
timeFrame: 6 months after beginning
measure: Physical Activity level
timeFrame: Beginning
measure: Change from Baseline Physical Activity at 3 months
timeFrame: 3 months from beginning
measure: Change from Baseline Physical Activity at 6 months
timeFrame: 6 months from beginning
measure: Drug Adherence
timeFrame: Beginning
measure: Change from Baseline Drug Adherence at 3 months
timeFrame: 3 months after beginning
measure: Change from Baseline Drug Adherence at 6 months
timeFrame: 6 months after beginning
measure: Quality of Life Assessed by SF-36v2
timeFrame: Beginning
measure: Change from Baseline Quality of Life Assessed by SF-36v2 at 3 months
timeFrame: 3 months after beginning
measure: Change from Baseline Quality of Life Assessed by SF-36v2 at 6 months
timeFrame: 6 months after beginning
Secondary outcomes:
measure: Baseline blood pressure
timeFrame: Beginning
measure: Change from Baseline blood pressure at 3 months
timeFrame: 3 months after beginning
measure: Change from Baseline blood pressure at 6 months
timeFrame: 6 months after beginning
measure: Baseline heart rate
timeFrame: Beginning
measure: Change from Baseline heart rate at 3 months
timeFrame: 3 Months After Beginning
measure: Change from Baseline heart rate at 6 months
timeFrame: 6 Months After Beginning
measure: Baseline Body Mass Index
timeFrame: Beginning
measure: Change from Baseline Body Mass Index at 3 months
timeFrame: 3 months after Beginning
measure: Change from Baseline Body Mass Index at 6 months
timeFrame: 6 months after Beginning
measure: Baseline body fat ratios
timeFrame: Beginning
measure: Change from Baseline Body Fat Ratios at 3 Months
timeFrame: 3 Months After Beginning
measure: Change from Baseline Body Fat Ratios at 6 Months
timeFrame: 6 Months After Beginning
measure: Baseline waist/hip ratio
timeFrame: Beginning
measure: Change from Baseline waist/hip ratio at 3 Months
timeFrame: 3 Months after Beginning
measure: Baseline Diet and Nutritional Habits
timeFrame: Beginning
measure: Change from Baseline Diet and Nutritional Habits at 3 months
timeFrame: 3 Months after Beginning
measure: Change from Baseline Diet and Nutritional Habits at 6 months
timeFrame: 6 Months after Beginning
measure: Baseline Energy Intake
timeFrame: Beginning
measure: Change from Baseline Energy Intake at 3 months
timeFrame: 3 months after Beginning
measure: Change from Baseline Energy Intake at 6 months
timeFrame: 6 months after Beginning
Other outcomes:
Locations:
Study officials:
affiliation: Istanbul University
name: Suphi Vehid, Prof. Dr.
role: STUDY_CHAIR
References:
citation: 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.