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

NCT04733612 | Completed

• 1 other identifier: 20135
• Study Type: interventional
• Target: 125
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type2 Diabetes Mellitus

Keywords

Diabetes mellitus; Public health

Outcome Measures

Primary Outcomes (15)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (20)

• Baseline blood pressure

  Beginning

• Change from Baseline blood pressure at 3 months

  3 months after beginning

• Change from Baseline blood pressure at 6 months

  6 months after beginning

• Baseline heart rate

  Beginning

• Change from Baseline heart rate at 3 months

  3 Months After Beginning

Study Arms (2)

SMS Group

EXPERIMENTAL

In addition to traditional treatment received three to four informative SMS messages per week during the 6-month period

Other: Informative messages

Control Group

NO INTERVENTION

Followed in accordance with the traditional treatment schedule

Interventions

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.

SMS Group

Eligibility Criteria

• Age: 40 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University: lead

Related Publications (1)

• 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.

  PMID: 35330570 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Suphi Vehid, Prof. Dr.

  Istanbul University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 16, 2021
• First Posted: February 2, 2021
• Study Start: June 30, 2016
• Primary Completion: December 20, 2017
• Study Completion: February 26, 2018
• Last Updated: February 2, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share