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Diabetes MellitusDSMEPNCT05581264

Diabetes Self-Management Educational Program

A study testing Diabetes Self-Management Education Program in people with Diabetes Mellitus, run by Mutah University at 1 site in Jordan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Diabetes Mellitus
What is being tested?
Diabetes Self-Management Education Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteJordan
Study dates
28 Sep 2021to 30 Aug 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Jordan1 site
  • Diabetes Outpatient Clinic

    Amman

Other trials in Jordan

About this study

Official title: Effect of Diabetes Self-Management Educational Program on Diabetes Self-Care Activities, Illness Perceptions, Medication Adherence, Health-Related Quality of Life, and Glycemic Control in Patients With Poorly Controlled Type 2 Diabetes

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.

Read the 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.

Being tested
Diabetes Self-Management Education Program
Keywords
Diabetes Self-Care Activities, Illness Perceptions, Medication Adherence, Health Related Quality of Life, Glycemic Control
Medical subject headings
Diabetes Mellitus, Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diabetes Self-Management Education ProgramBehavioural

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

Study groups in NCT05581264
Study groupRoleWhat they receive
Self-Management Education ProgramExperimentalParticipants received the diabetes self-management education program. The education and counseling were maintained through follow-up via phone for the intervention group
Receives: Behavioral: Diabetes Self-Management Education Program
No Intervention/Control GroupNo interventionParticipants received the usual medical care prescribed by the patient's attending doctor.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, Week 24

  2. 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

    Measured: baseline, Week 12, Week 24

Secondary outcomes (3)
  1. Difference in illness perception scale scores between experimental group and control group across time

    The Brief Illness Perception Questionnaire (IPQ) was used to measure illness perception. The Brief IPQ has nine items, all of which are rated using a 0-10 response scale except the causal question. Five of the items assess cognitive illness representations: consequences (item 1), with higher scores representing a stronger belief that the illness will have serious consequences; timeline (item 2), with higher scores indicating a belief that the illness is going to last for a longer time; personal control (item 3) and treatment control (item 4), with higher scores indicating a higher level of belief in control or potential for cure of the illness; identity (item 5). Two of the items assess emotional representations: concern (item 6) and emotions (item 8), with higher scores indicating greater worries about health status. One item assesses illness comprehensibility (item 7), with higher scores indicating better understanding of the illness.

    Measured: Baseline, Week 24

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

    Self-reported medication adherence (Morisky Scale) was used to measure medication adherence. This scale assessed the probability that patients take their medications as prescribed. The Morisky Scale is an 8-item questionnaire with seven yes/no questions and one question answered on a 5-point Likert scale. Scores range from zero to eight and are categorized into three levels of adherence: 8=high adherence; 6-7=medium adherence; <6=low adherence. The Morisky scale has been used across many chronic diseases, including diabetes, as a self-reported measure of adherence to medications and has demonstrated good reliability and predictive validity.

    Measured: Baseline, Week 24

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

    The Short-Form 36-item survey (SF-36) was used to assess the HRQOL. The SF-36 is a self-assessment scale, consisting of 36 questions under eight subscales: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. Subscale scores are calculated according to standard procedures, yielding score values of 0 to 100, where higher scores indicate better HRQOL.

    Measured: baseline, Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2022
  2. Study start28 Sep 2021
  3. Primary completion30 Aug 2022
  4. Study completion30 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05581264
Sponsor's protocol ID
120-14-388
Acronym
DSMEP
Status last verified
Oct 2022
First submitted
12 Oct 2022
Last updated
14 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The individual participant data has been recorded in an anonymous format digitally and for the sake of confidentiality, participant data will not be shared according to IRB Committee guidelines. However, data will be disseminated in the form of publications, conferences, and presentations. Nevertheless, data may be shared on official request after consultation with the research team and IRB Committee.

Questions about this trial

What is this clinical trial studying?

A study testing Diabetes Self-Management Education Program in people with Diabetes Mellitus, run by Mutah University at 1 site in Jordan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in diabetes self-care behaviors scale scores between experimental group and control group across time (time frame: Baseline, Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2022.

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Diabetes Self-Management Educational Program | AzTrials