Diabetes Self-Management Educational Program

NCT05581264 | Completed

• 1 other identifier: 120-14-388
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Keywords

Diabetes Self-Care Activities; Illness Perceptions; Medication Adherence; Health Related Quality of Life; Glycemic Control

Outcome Measures

Primary Outcomes (2)

• Difference in diabetes self-care behaviors scale scores between experimental group and control group across time

  Diabetes Self-Management Questionnaire (DSMQ) DSMQ was used to measure the patient's self-care behaviors. Respondents will be asked to rate their specific self-care activities of last 3 months on a 16-item DSMQ.This questionnaire involves a four point likert scale (ranging from 0 - 'does not apply to me' to 3 - 'applies to me very much'). There are 4 subscales of this study tool; namely, 'Glucose Management' which is comprised of 5 items, 'Dietary Control' comprised of 4 items, 'Physical Activity comprised of 3 items, and, 'Health-Care Use' comprised of 3 items. Higher scores will represent more effective self-care.

  Baseline, Week 24

• Difference in Glycated hemoglobin (HbA1c) level between experimental group and control group across time

  HbA1c was analyzed from a sample of venous blood. HbA1c \< 7.0% is considered as the good glycemic control and HbA1c ≥ 7.0% will be considered as poorly controlled glucose level

  baseline, Week 12, Week 24

Secondary Outcomes (3)

• Difference in illness perception scale scores between experimental group and control group across time

  Baseline, Week 24

• Difference in medication adherence scale scores between experimental group and control group across time

  Baseline, Week 24

• Difference in health related quality of life HRQOL scale scores between experimental group and control group across time

  baseline, Week 24

Study Arms (2)

Self-Management Education Program

EXPERIMENTAL

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

Behavioral: Diabetes Self-Management Education Program

No Intervention/Control Group

NO INTERVENTION

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

Interventions

Diabetes Self-Management Education Program BEHAVIORAL

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

Self-Management Education Program

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mutah University: lead

Study Sites (1)

Diabetes Outpatient Clinic

Amman, Jordan

Location

MeSH Terms

Conditions

Diabetes Mellitus; Medication Adherence

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Omar A Alkhawaldeh

  Mutah University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: To reduce performance bias after the randomization process, blinding is adopted. However, due to the conflicting requirements of ethical and methodological aspects in designing a randomized controlled trial with a psychosocial intervention, double-blinding and randomizing each individual participant posits a huge challenge. Patients and outcome assessors were blinded in a way that none of them will know which group is considered the experimental group and the control group.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Model Details: This study is a two-arm - experimental vs. control group Randomized Controlled Trial. The sampling frame was patients with uncontrolled type 2 diabetes registered in two outpatient diabetes clinics located in two cities in Jordan. Diabetes self-management program is delivered by a trained diabetes educator facilitator in diabetes management. In addition to the usual care, the intervention group was provided with an education program that consisted of nine 60-min sessions, which included face-to-face interactive sessions with the dissemination and presentation of written and visual materials. The education and counseling were maintained through follow-up (24 weeks) via phone for the intervention group. The control group received only usual care and they were followed according to the institution's diabetes follow-up protocol.

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 14, 2022
• Study Start: September 28, 2021
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: October 14, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)