Clinical trial NCT06325917: Effect of Diabetes Self-management Education and Support on Glycemic Control Among Patients With Type 2 Diabetic
Official title: Effect of Self-management Education With Ongoing Support Using Social Media on Glycemic Control Among Patients With Diabetes Type 2.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes
Glycemic control
self-management education
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two arms parallel randomized controlled
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: glycemic control
timeFrame: baseline and three Monthes post intervention
Secondary outcomes:
measure: diabetes self management behaviors
timeFrame: Three moths after the intervention
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: University of Jordan
Study officials:
References:
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