Diabetes Self-Management Educational Program

NCT ID: NCT05581264

Last Updated: 2022-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-28
• Study Completion Date: 2022-08-30

Brief 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.

Detailed 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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Self-Management Education Program

Participants received the diabetes self-management education program. The education and counseling were maintained through follow-up via phone for the intervention group

Group Type: EXPERIMENTAL

Diabetes Self-Management Education Program

Intervention Type: BEHAVIORAL

diabetes self-management education and counseling program with follow-up via phone for the intervention group for 24 weeks

No Intervention/Control Group

Participants received the usual medical care prescribed by the patient's attending doctor.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Diabetes Self-Management Education Program

diabetes self-management education and counseling program with follow-up via phone for the intervention group for 24 weeks

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age from 18 to 65 years
• Patients with a known diagnosis of type 2 diabetes for at least one year
• Patients with HbA1c >7%, for uncontrolled diabetes
• Able to read, write, and speak Arabic
• Having the ability of autonomous behavior, informed consent, and voluntary participation in the study.
• Receiving oral antidiabetic and/or insulin therapy
• Able to communicate and does not have hearing, speech or psychiatric problems that prevent communication
• Receiving care at one of the participating diabetes clinics

Exclusion Criteria

• Has an acute or terminal illness or serious mental illness or physical deterioration
• Has any other severe medical conditions that might make it difficult to attend educational sessions
• Planning to travel for longer than 6 weeks during the 6-month intervention period
• Patients not willing to participate in the study
• Type 1 diabetes mellitus, gestational diabetes mellitus, and other special types of diabetes
• Patients who were unable to provide a consent form
• Patients who have hearing, speech, and psychiatric problems that prevent communication
• Cognitive impairment and/or learning disabilities
• Recruited in other research and/or diabetes educational programs during the study period

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mutah University

OTHER

Sponsor Role: lead

Responsible Party

Omar Alkhawaldeh

associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Omar A Alkhawaldeh

Role: PRINCIPAL_INVESTIGATOR

Mutah University

Locations

Diabetes Outpatient Clinic

Amman, , Jordan

Countries

Jordan

Other Identifiers

120-14-388

Identifier Type: -

Identifier Source: org_study_id