Clinical Trials Logo

Clinical Trial Summary

Diabetes mellitus is the third most prevalent chronic disease globally. It is a metabolic disorder characterized by elevated blood glucose because of impaired insulin production, reduced insulin effectiveness, or both. It is a major contributor to physical disability and impaired quality of life. Diabetes Self-Management programs help to control blood glucose, reduce hospitalization, and increase compliance; however, the program is underutilized in primary care settings globally, due to cognitive, financial, behavioral, and emotional factors. Addressing the increasing trend in diabetes, Jordan is currently in need of a diabetes self-management program that promotes patient empowerment and overall well-being. The primary aim of this study was to investigate the effectiveness of a diabetes self-management education program for patients with type 2 diabetes in improving self-care, medication adherence, illness perception, health-related quality of life, and glycemic control (HbA1c level). This study is a two-arm randomized controlled trial study of patients with type 2 diabetes attending two outpatients' diabetes clinic settings in Jordan. The education program and also usual medical care were applied to the intervention group, only usual medical care was applied to the control group.


Clinical Trial Description

Diabetes mellitus (DM) is a growing public health problem highly amenable to prevention and health promotion interventions. Diabetes mellitus is a chronic disease that requires ongoing medical care and ongoing patient self-management education and support to prevent acute complications and reduce the risk of chronic complications of diabetes. The prevalence of diabetes mellitus is reaching epidemic proportions in many parts of the world. Globally it is estimated that approximately 537 million adults (20-79 years) are living with diabetes according to International Diabetes Federation (2021). The total number of people living with diabetes is projected to rise to 643 million by 2030 and 783 million by 2045. Moreover, the International Diabetes Federation estimated that diabetes caused at least USD 966 billion dollars in health expenditure - 9% of total spending on adults. In Jordan, the age-standardized prevalence rate of diabetes and impaired fasting blood glucose was 17.1% and 7.8%, respectively. The high prevalence of diabetes point to the need for immediate implementation of educational programs and other interventions to prevent and control the burden of diabetes in Jordan. The majority of researchers and clinicians advocate that diabetes is a disease that requires diabetes self-management care abilities and that patients need to be taught diabetes self-management skills to become reliable, capable, and sufficiently responsible to take care of themselves. Diabetes self-management is of great importance because the adoption of healthy lifestyle behaviors will produce optimum glycemic control for diabetes, which in turn will help minimize or prevent subsequent acute and long-term complications of the disease. Diabetes is a lifelong disease that needs behavioral changes, most often through education, counseling, and support through behavioral interventions offered by health care providers, to enable diabetic patients to perform self-care activities. Behavioral changes are complex processes that are influenced by such factors as illness perceptions, quality of life, beliefs, attitudes, skills, motivation, and social support. In Jordan, diabetes nursing education services are at an early stage of development and have recently been introduced to healthcare facilities and the implementation of such services is still limited. Improving diabetes self-management, preventing diabetes complications, and reducing health service utilization for patients with diabetes are ongoing challenges for nurses and other healthcare providers globally and in Jordan. There is a need to investigate the impact of implementing a nursing educational care program on reaching glycemic control goals and other clinical outcomes because of the increasing prevalence of diabetes and the limited implementation of effective nursing services for patients with type 2 diabetes in Jordan. The primary aim of this study is to evaluate the effect of a structured diabetes education program on glycemic control and other health-related clinical outcomes in patients with poorly controlled type 2 diabetes. This study is a two-arm randomized controlled trial of patients with type 2 diabetes attending two outpatient diabetes clinic settings in Jordan. The education program for 24 weeks and also usual medical care were applied to the intervention group, only usual medical care was applied to the control group. The education intervention consists of structured face-to-face individual/ group-based education and counseling sessions with telephone follow-up instructions. At each clinic visit, diabetes nurse educators meet the participants in the intervention group in a private room. Printed educational material was developed by the researchers containing information about diabetes, diabetes medications, lifestyle modifications, and self-care activities also given to patients in the intervention group. Diabetes nurse educators also encourage patients to adhere to prescribed medications and advise participants to follow healthy lifestyle behaviors. Finally, follow-up telephone calls were made by the diabetes nurse educator to each intervention participant to discuss and review the prescribed therapy, to emphasize the importance of adherence to the treatment plan, and to answer patient questions or address their concerns. The education and counseling were maintained through follow-up via phone for the intervention group. The control group was not exposed to the structured education intervention but continued with their usual care provided by the medical and nursing staff and was followed according to the institution's routine diabetes follow-up protocol. The baseline assessment (pre-intervention) for both groups involves obtaining data about study outcome measures. The primary outcomes are glycemic control (HbA1c level) and self-care activities; whereas medication adherence, illness perception, and health-related quality of life are the secondary outcomes. Follow-up assessment involves obtaining data about HbA1c results for both the intervention group and the control group from their medical records at 3 and 6 months intervals. The baseline questionnaires were re-administered at six months post-intervention for both groups. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05581264
Study type Interventional
Source Mutah University
Contact
Status Completed
Phase N/A
Start date September 28, 2021
Completion date August 30, 2022

See also
  Status Clinical Trial Phase
Completed NCT03743779 - Mastering Diabetes Pilot Study
Completed NCT03786978 - Pharmaceutical Care in the Reduction of Readmission Rates in Diabetes Melitus N/A
Completed NCT01804803 - DIgital Assisted MONitoring for DiabeteS - I N/A
Completed NCT05039970 - A Real-World Study of a Mobile Device-based Serious Health Game on Session Attendance in the National Diabetes Prevention Program N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT04068272 - Safety of Bosentan in Type II Diabetic Patients Phase 1
Completed NCT03243383 - Readmission Prevention Pilot Trial in Diabetes Patients N/A
Completed NCT03730480 - User Performance of the CONTOUR NEXT and CONTOUR TV3 Blood Glucose Monitoring System (BGMS) N/A
Recruiting NCT02690467 - Efficacy, Safety and Acceptability of the New Pen Needle 34gx3,5mm. N/A
Completed NCT02229383 - Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus Phase 3
Recruiting NCT06181721 - Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Patients With Type 1 and Type 2 Diabetes N/A
Recruiting NCT04489043 - Exercise, Prediabetes and Diabetes After Renal Transplantation. N/A
Withdrawn NCT03319784 - Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients Phase 4
Completed NCT03542084 - Endocrinology Auto-Triggered e-Consults N/A
Completed NCT02229396 - Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo Phase 3
Recruiting NCT05544266 - Rare and Atypical Diabetes Network
Completed NCT01892319 - An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
Completed NCT05031000 - Blood Glucose Monitoring Systems: Discounter Versus Brand N/A
Recruiting NCT04039763 - RT-CGM in Young Adults at Risk of DKA N/A
Recruiting NCT03462420 - Physiotherapy Program for Managing Adhesive Capsulitis in Patients With Diabetes N/A