Diabetic Self-care Education at Primary Health Care in Saudi Arabia: A Pragmatic Randomized Trial in Tabuk

NCT04847856 | Completed DMC

• 1 other identifier: H-07-TU-077
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetes Self-care Education (DSCE) is a formal term used to describe the ongoing process of facilitating the knowledge, skills, and ability necessary for diabetes self-care. Supporting self-care is a crucial aspect of any health service, especially the one that targeting diabetes. It has shown a positive effect on the clinical, psychological, and behavioural aspects of diabetics. However, culturally adapted educational services that recognize the context should be established and used carefully, as most of the social media and YouTube educational products are not relevant most of the time. Diabetic patients who receive no education about their diabetes, are four times as likely to develop complications as those who do not. Oppositely, those who attending diabetes education programs are less likely to develop long-term complications. The core question of the trial is to find an answer to the question: how the Diabetes self-care information, education provided by trained health care educator at primary care is effective in controlling patterns of blood glucose, reducing BMI, and enhancing self-care behaviour among diabetic patients attending chronic care clinic compared to the control group receiving routine care for diabetes.

Conditions

Self-care; Preventive Care; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• To compare the mean differences in the: Blood glucose level, BMI, Waist circumference between intervention and control groups

  A reduction in the average blood glucose level, BMI, waist circumference over12 months' duration.

  12 months

Secondary Outcomes (1)

• To compare the mean differences in the: HbA1C, Serum cholestrol, and blood pressure between intervention and control groups

  12 months

Other Outcomes (1)

• To explore the knowlege and skills gained by nurse staff as a result of their participation in the trial intervention.

  12 months

Study Arms (2)

List of health centers that randomly allocated to receive the intervention

EXPERIMENTAL

The intervention was structured Diabetes self-care information, education, and communication (IEC) delivered to the participants at the selected primary health care center level. The Information, education, and communication intervention were delivered by relevant and trained health animators working in chronic care clinics. The intervention was composed of sessions and the participants were planned to attend five structured sessions on diabetes self-care at months: 1, 2, 3,4,5\&6. Besides, the participants were provided with a single-page checklist with a to-do list of activities and simple advice that covering the various aspects of diabetes self-care.

Behavioral: Diabetic care Information, education, and communication intervention will be delivered by relevant and trained health animators working in chronic care clinic.

List of health centers that randomly allocated to receive routine care

NO INTERVENTION

The comparators were type II diabetic patients of both genders attending the selected primary health care centres that receiving routinely provided diabetic care including advice from the health care providers. Participants were interviewed at the start of the trial to collect the baseline data about self-care with measurements of blood glucose level, serum cholesterol level, blood pressure, BMI, and waist circumference. At the end of the trial, the sam participants were interviewed to collect end-line data and similar measurements.

Interventions

Diabetic care Information, education, and communication intervention will be delivered by relevant and trained health animators working in chronic care clinic. BEHAVIORAL

The training sessions and the IEC materials were adapted from John Hopkins University studies on self-care for diabetic patients.

Also known as: Self-care progression card and pictorial IEC messages were prepared and given to the patients or co-family members.

List of health centers that randomly allocated to receive the intervention

Eligibility Criteria

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

You may qualify if:

• The participants were type II diabetic patients of both genders attending the selected primary health care centers irrespective of their duration of disease and the types of medication currently received. The participants were adults aged 18 years and above.

You may not qualify if:

• Children and young adults with juvenile diabetes mellitus were excluded. In addition, severely ill patients, patients with mental disorders were also excluded.

Sponsors & Collaborators

• University of Tabuk: lead

Study Sites (1)

Public Primary Health Care Centers in the Tabuk City

Tabuk, 71491, Saudi Arabia

Location

Related Publications (1)

• Elfakki FAM, Elnimeiri MK, Assil SM, Frah EA, Abdalla NHI. Effectiveness of diabetes self-care education at primary health care centres in Saudi Arabia: A pragmatic randomized trial in Tabuk. J Family Med Prim Care. 2022 Jan;11(1):144-149. doi: 10.4103/jfmpc.jfmpc_985_21. Epub 2022 Jan 31.

  PMID: 35309655 RESULT

Related Links

• Effectiveness of diabetes self-care education at primary health care centres in Saudi Arabia: A pragmatic randomized trial in Tabuk

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Mustafa K Elnimeiri, MD

  Al- Neelain University, Sudan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Preventive Medicine and Epidemiology

Model Details: This is a 12 months randomized clustered trial that recruited individuals with type II diabetes mellitus attending primary health care clinics in Tabuk city, Saudi Arabia. Health centres will be divided into two groups( intervention\& control) using Random Number Generator.

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 19, 2021
• Study Start: March 30, 2020
• Primary Completion: March 29, 2021
• Study Completion: April 10, 2021
• Last Updated: December 9, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)