Effect of Diabetes Self-management Education and Support on Glycemic Control Among Patients With Type 2 Diabetic

Diabetes Mellitus, Type 2 Clinical Trial

— DSMES  

Official title:

Effect of Self-management Education With Ongoing Support Using Social Media on Glycemic Control Among Patients With Diabetes Type 2.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06325917
• Other study ID #: 101271-5
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: July 30, 2024

Study information

• Verified date: March 2024
• Source: University of Jordan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Introduction: Diabetes mellitus (DM) is one of the chronic diseases that can have an impact on increasing morbidity, disability, and death. Social media has become a valuable resource for people with diabetes in improving self-management skills Applying diabetes self-management education with ongoing support using social media produces behavioral changes, empowerment, and cost-effectiveness. purpose: the purpose of this study is to examine the effect of self-management education with ongoing support using social media (WhatsApp) on glycemic control among patients with uncontrolled diabetes. Method: 140 patients with diabetes type 2 attending outpatients' diabetes clinic setting in Aqaba will participate in a two-arm randomized controlled trial study. Self-management education will be applied for all participants, ongoing support using social media (what's app) will be applied to the intervention group, and only usual diabetes care by a diabetes specialist nurse will be applied to the control group.

Description:

Type 2 diabetes(DM2) consider a significant cause of morbidity and mortality worldwide. Around 1.5 million deaths globally, are directly attributed to diabetes each year. Adults with diabetes have a two- to three-fold increased risk of heart attacks and strokes, approximately, one million people were blinded due to diabetes. Also, Diabetes is the leading cause of kidney failure. Uncontrolled DM2 has a negative impact on the healthcare system, patients, and community. Similarly, it has an adverse impact on the quality of life by its harmful complications that increase patients' disabilities, high hospitalization rates, and 30-day readmissions rate. Patients with DM2 have a high prevalence of DM-related stress. Additionally, a lack of diabetes awareness threatened patients' self-esteem stability, autonomy, and patient's ability to self-care and manage . in Jordan, about 74.5 % of patients with DM had uncontrolled diabetes, despite their good knowledge level about diabetes and its complications. however, this knowledge did not translate into the ability to change patients 'behaviors regard to self-care activities this means that we need more innovative programs that encourage patients to utilize the knowledge they have . Several unstructured diabetes self-management education (DSME) aimed to increase patients' awareness of the disease and its management was performed in most healthcare settings, this type of education has a short-term impact on patients' attitudes toward self-care activities. a significant gap in primary care about diabetes-related knowledge and practices in caring for patients with diabetes, Previous research has documented a lack of sufficient communication about DSME between patients and physicians. Diabetes care and education shall be designed with the integration of patient-centered care (PCC), which is a model of clinical practice aimed at shifting patient-provider relationships from authoritarianism to shared decision-making, PCC was described as "providing care that is respectful of and responsive to individual patient preferences, needs, and values and ensuring that patient values guide all clinical decisions". For enhancing diabetes self-management many educational programs were designed and examined in several studies, the ADA has recommended using the Diabetes self-management education and support (DSMES), which is an education and support model of care designed and provided using a PCC that respects patients' needs and surrounded context with coordination of diabetes nurse and other health care providers efforts, to achieve the seven self-care behaviors of a patient as reliable outcome measures of diabetes self-management " being active, healthy eating, taking medication, monitoring, solving problems, reducing risks and healthy coping" . Applying the DSMES program produces behavioral changes, empowerment, and cost-effectiveness. In addition, it has a positive impact on health outcomes such as reduces diabetes distress, improves the quality of life, self-efficacy, empowerment, healthy coping, knowledge, and self-care behaviors. The available evidence suggests that DSME enhance glycemic control but it's not enough alone, many educated patients have well knowledge about diabetes and its management, but they didn't adhere to self-care activities. some literature argues that patients with diabetes need ongoing follow-up and support by diabetes specialists to enhance patients abilities on managing themselves. There have been growing efforts to implement new approaches for self-management interventions that improve diabetes control . Recently, information technology use has increased dramatically resulting in improved communication. Social Media is defined as the Internet-based tools that permit individuals to communicate, gather and share information, ideas, and images, and to team up with other users in real-time. Social media channels may facilitate digital health interventions, which offer continuous support, efficient communications, and overcome barriers associated with face-to-face modalities. Patients consider social media as a source to get disease-certain information, interact quickly and efficiently with others and share medical information with a community of patients having similar problems.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 140
• Est. completion date: July 30, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. have a confirmed diagnosis of DM2 in their medical records at last one year.

2. age 18 years old or more

3. able to read and write Arabic

4. agree to participate in the study

5. have uncontrolled blood sugar with HbA1C 8% or more

6. able to use the WhatsApp application

7. Having the ability to autonomous behavior

Exclusion Criteria:

• exclusion criteria:

1. the presence of mental disorders

2. complications of acute diabetes or inability to take care of themselves

3. other serious diseases, such as severe cardiovascular and cerebrovascular diseases, severe kidney disease stage 3, cancer, and visual impairment due to complications of T2DM

4. gestational diabetes

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• what's app ongoing support
daily educational messages and reminders sent through WhatsApp. The educational material related to diabetes self-management behaviors (AADE7 Self-Care Behaviors, diabetes and genetics, and endocrinology center, also the Ministry of Health in Jordan diabetes. individual bidirectional communication between the participants and the investigator, which will allow participants to seek advice and get free-of-charge feedback and consultation.
• usual care
monthly visit and follow-up at the diabetes education clinic by a diabetes nurse specialist providing DSMES

Locations

Country	Name	City	State
Jordan	University of Jordan	Amman

Sponsors (1)

Lead Sponsor	Collaborator
University of Jordan

Country where clinical trial is conducted

Jordan, 

References & Publications (8)

Ajlouni K, Batieha A, Jaddou H, Khader Y, Abdo N, El-Khateeb M, Hyassat D, Al-Louzi D. Time trends in diabetes mellitus in Jordan between 1994 and 2017. Diabet Med. 2019 Sep;36(9):1176-1182. doi: 10.1111/dme.13894. Epub 2019 Jan 25. — View Citation

American Association of Diabetes Educators. An Effective Model of Diabetes Care and Education: Revising the AADE7 Self-Care Behaviors(R). Diabetes Educ. 2020 Apr;46(2):139-160. doi: 10.1177/0145721719894903. Epub 2020 Jan 12. — View Citation

Azami G, Soh KL, Sazlina SG, Salmiah MS, Aazami S, Mozafari M, Taghinejad H. Effect of a Nurse-Led Diabetes Self-Management Education Program on Glycosylated Hemoglobin among Adults with Type 2 Diabetes. J Diabetes Res. 2018 Jul 8;2018:4930157. doi: 10.11 — View Citation

Gabarron E, Arsand E, Wynn R. Social Media Use in Interventions for Diabetes: Rapid Evidence-Based Review. J Med Internet Res. 2018 Aug 10;20(8):e10303. doi: 10.2196/10303. — View Citation

Omar MA, Hasan S, Palaian S, Mahameed S. The impact of a self-management educational program coordinated through WhatsApp on diabetes control. Pharm Pract (Granada). 2020 Apr-Jun;18(2):1841. doi: 10.18549/PharmPract.2020.2.1841. Epub 2020 May 3. — View Citation

Pal K, Dack C, Ross J, Michie S, May C, Stevenson F, Farmer A, Yardley L, Barnard M, Murray E. Digital Health Interventions for Adults With Type 2 Diabetes: Qualitative Study of Patient Perspectives on Diabetes Self-Management Education and Support. J Med — View Citation

Ventola CL. Social media and health care professionals: benefits, risks, and best practices. P T. 2014 Jul;39(7):491-520. — View Citation

Zisman-Ilani Y, Obeidat R, Fang L, Hsieh S, Berger Z. Shared Decision Making and Patient-Centered Care in Israel, Jordan, and the United States: Exploratory and Comparative Survey Study of Physician Perceptions. JMIR Form Res. 2020 Aug 3;4(8):e18223. doi: 10.2196/18223. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glycemic control	This is the primary outcome of the study that will be assessed by the Glycated hemoglobin (A1C)	baseline and three Monthes post intervention
Secondary	diabetes self management behaviors	will be measured by summary of diabetes self care activities DSCA scale. Is a brief self-report questionnaire and consists of 12 items divided into five self care management activities: diet, practicing exercise, patient self-monitoring of blood glucose, foot care and taking DM medication.This questionnaire is scored by taking the raw score from each set of self care management tasks Then these scores are averaged to form a combined score for each area or subscale.	Three moths after the intervention