Adherence and Beliefs About Medications, and Illness Perception Among Type 2 Diabetic Patients in Assiut Main Hospital

NCT05301855 | Unknown

• 1 other identifier: Adherence to medication in DM
• Study Type: observational
• Target: 417
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetes mellitus (DM) is considered one of the oldest fast-growing publichealth problems. It's a chronic metabolic disorder characterized mainly by highlevel of glucose level, associated globally with increased morbidity andmortality particularly in developing countries \[1\].DM leads to serious problems in heart, blood vessels, kidney and nerves.The World Health Organization (WHO) had anticipated that DM is going tobecome the seventh most significant primary cause of death worldwide by theyear 2030 \[2\]

Conditions

Diabetes Mellitus, Type 2; Adherence, Medication

Outcome Measures

Primary Outcomes (5)

• through semi-structured questionnaires which will be filled by the researcher herself. The questionnaire will be composed of five parts:

  The first part will inquire about sociodemographic data such as age, sex, educational level, occupation, residence, and marital status.

  2 years

• The second part is about clinical data

  The second part is about clinical data including BMI, duration of diabetes, type and number of prescribed medications, number of comorbid conditions, number of diabetes-related complications, and patients' most recent HbA1c levels were taken from medical records. HbA1c levels of ≥ 8% indicate suboptimal glycemic control in patients with T2D.

  2 years

• The third part of the questionnaire is the Arabic version of Morisky Medication Adherence Scale (MMAS-8)

  It remains one of the most widely used mechanisms to assess patient adherence . It consists of 8 questions. Response choices are "yes" or "no" for items 1 through 7 and Item 8 has a five-point Likert response scale. Each "no" response is rated as 1 and each "yes" response is rated as 0 except for item 5, in which each "yes" response is rated as 1 and each "no" response is rated as 0. For Item 8, the code (0-4) must be standardized by dividing the result by 4 to calculate a summated score . Total scores on the MMAS-8 range from 0 to 8, with scores of 8 reflecting high adherence, 7 or 6 reflecting medium adherence, and \<6 reflecting low adherence

  2 years

• The fourth part of the questionnaire is the Brief Illness Perception Questionnaire (B-IPQ).

  B-IPQ is a rapid assessment tool with a Cronbach's alpha of 0.65 that measures eight different aspects of illness perception: consequences, timeline, personal control, treatment control, identity, concerns, understanding, and emotional representation \[15\]. The B-IPQ is a 9-item instrument that measures illness perception from eight different aspects using an 11-point Likert scale. A higher score reflects a more threatening view of the illness, while a lower score indicates a benign view of the illness

  2 years

• The fifth part of the questionnaire is the Beliefs about medicine which is assessed using the Arabic version of the Beliefs about Medicines Questionnaire Specific (BMQ-Specific).

  It includes two subscales, which evaluate patients' perceptions of the necessity of medicine in controlling their illness (Necessity-Specific) and concerns about potential adverse effects of medicine (Concerns-Specific). Each subscale consists of 5 items and is scored on a 5-point Likert scale. High scores on the Necessity-Specific subscale indicate that the patient perceives their medicine as necessary, whereas high scores on the Concerns-Specific subscale indicate that the patient is concerned about potential adverse effects

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study will be conducted in Assiut University Hospital. The target population will include diabetic patients attending Diabetes Clinic in Assiut University Hospital. The clinic offers various services including clinician consultations, health education, medication dispensing, foot, and vision screening. The clinic is also responsible for treating and monitoring patients with diabetes. All patients who fulfill the inclusion criteria and presented to Diabetes Clinic in Assiut University Hospital will be included in the present study

You may qualify if:

• Patients who are diagnosed with type 2 DM for at least 1 year according to the diagnostic criteria of the 10th revision of the International Classification of Diseases (ICD-10).
• Patients treated with insulin or oral medication or both for at least 6 months.
• Age group: adult patients (\> 18 years old) will be included in the present study.

You may not qualify if:

• Newly diagnosed diabetic patients or ill on the day of recruitment, or not taking any medications for type2 DM 2- Patients with type1 DM 3- Psychiatric patients or on anti-depressant treatment or using psychotropic drugs affecting their cognitive ability.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of medicine

Asyut, 71511, Egypt

RECRUITING

Related Publications (4)

• Reba K, Argaw Z, Walle B, Gutema H. Health-related quality of life of patients with diagnosed type 2 diabetes in Felege Hiwot Referral Hospital, North West Ethiopia: a cross-sectional study. BMC Res Notes. 2018 Aug 2;11(1):544. doi: 10.1186/s13104-018-3625-x.

  PMID: 30068392 BACKGROUND

• Ali M, Alemu T, Sada O. Medication adherence and its associated factors among diabetic patients at Zewditu Memorial Hospital, Addis Ababa, Ethiopia. BMC Res Notes. 2017 Dec 4;10(1):676. doi: 10.1186/s13104-017-3025-7.

  PMID: 29202857 BACKGROUND

• Robert AA, Al Dawish MA. The Worrying Trend of Diabetes Mellitus in Saudi Arabia: An Urgent Call to Action. Curr Diabetes Rev. 2020;16(3):204-210. doi: 10.2174/1573399815666190531093735.

  PMID: 31146665 BACKGROUND

• Olorunfemi O, Ojewole F. Medication belief as correlate of medication adherence among patients with diabetes in Edo State, Nigeria. Nurs Open. 2018 Sep 14;6(1):197-202. doi: 10.1002/nop2.199. eCollection 2019 Jan.

  PMID: 30534409 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Medication Adherence

Condition Hierarchy (Ancestors)

Diabetes Mellitus; 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

Central Study Contacts

Zeinab G Abdelhamid, MD

CONTACT

01094838810; Zeinab_gatasalva@yahoo.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: March 31, 2022
• Study Start: March 1, 2022
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

EG (1)