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

26 mars 2022 mis à jour par: Zeinab Galal Eldeen Abdelhamid, Assiut University

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

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]

Aperçu de l'étude

Statut

Recrutement

Description détaillée

Diabetes mellitus (DM) is considered one of the oldest fast-growing public health problems. It's a chronic metabolic disorder characterized mainly by high level of glucose level, associated globally with increased morbidity and mortality 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 to become the seventh most significant primary cause of death worldwide by the year 2030 [2].

Main types of DM include type1 DM where the body stops making insulin, and type 2 DM which is more common, usually in adults when the body becomes resistant to insulin or doesn't make enough insulin [3].

Currently, 463 million persons suffer from diabetes worldwide. In addition, 55 million in Middle East and North Africa (MENA) Region suffer from diabetes, and it is estimated that by 2045 this will rise to 108 million according to the International Diabetes Federation (IDF) [4] Egypt is considered the ninth leading country in the world for the number of type 2 diabetes patients and its prevalence was nearly tripled over the last 2 decades, reaching 15.2% as nearly 8 million of adults suffer from type 2 DM, expecting to be doubled by 2045, urging the global community to recognize DM as one of the most important health challenges of the twenty first century [4].

Hence comes the importance of self-management in patients with type 2 DM in reducing complications from the disease and improving overall health outcomes. These important self-management behaviors include taking medications regularly, healthy diet, doing physical activities, quitting smoking, foot care and self-monitoring blood glucose level [5].

Adherence of patients with type 2 DM to medication is associated with better balanced glycemic control (HbA1c <7%), thus helping in reduction of microvascular and macrovascular complications [6].

Adherence to medication is mainly influenced by several factors such as demographic, socioeconomic, cultural, health system related factors, educational and personal factors such as patient's age, complexity of medication, side effects, cost, availability, accessibility and whether they're receiving emotional and social support from their families [7].

Mental representation of DM affect patients' coping behavior. Many patients lack the understanding of type 2 DM. Perception of the disease is important, it's not just about taking the prescribed medication, it's about the extent to which the patient follows medical instructions [8].

Studies have showed that illness perception and beliefs about medication by type 2 DM patients is commonly linked with their adherence to medication and in return better glycemic control [9].

Perception is about everything regarding the illness such as illness identity, time line of the disease, consequences, comorbid conditions, number of hospital admission, whether it can be controlled or not, and emotional response to being diabetic [10]. Beliefs in self-control and self-management over health will affect adherence to treatment regimens and glycemic control [9].

Perception about illness shapes self-management behavior. If patients have strong perception about treatment plan and regimen with personal control, it'll lead to lower level of HbA1c and better health outcome [10].

Patients' beliefs about medication are mainly about the necessity of taking the prescribed medication to maintain their health now and in the future, and concerns about the possible negative effects of taking the medication such as addiction or long-term adverse effects from regular use. Some patients believe that medication helps them, while others believe that multiple harmful effects of the treatment may outweigh any positive outcomes. Some of the patients who have strong opinions about their medication avoid taking it or, conversely, abuse it [11].

Patients who are convinced that a specific medication is essential for their health are much more likely to adhere to the treatment than those who do not hold such a belief [12].

We hypothesize that some factors associated with non-adherence to medication can be investigated so that interventions can be implemented to increase adherence to medication, helping in achieving better glycemic control and better health outcomes and reducing complications.

As data concerning diabetic patients' adherence are deficient in upper Egypt, this study will help in filling the gap on illness perception and beliefs about medication, which in turn affects patients' adherence to medication and thus better glycemic control in type 2 DM.

Type d'étude

Observationnel

Inscription (Anticipé)

417

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

      • Assiut, Egypte, 71511
        • Recrutement
        • Faculty of Medicine

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

N/A

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

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

La description

Inclusion Criteria:

  • 1- 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).

    2- Patients treated with insulin or oral medication or both for at least 6 months.

    3- Age group: adult patients (> 18 years old) will be included in the present study.

Exclusion Criteria:

  • 1- 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
through semi-structured questionnaires which will be filled by the researcher herself. The questionnaire will be composed of five parts:
Délai: 2 years
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
Délai: 2 years
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)
Délai: 2 years
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).
Délai: 2 years
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).
Délai: 2 years
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

Collaborateurs et enquêteurs

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Parrainer

Publications et liens utiles

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Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Anticipé)

1 mars 2022

Achèvement primaire (Anticipé)

1 novembre 2024

Achèvement de l'étude (Anticipé)

1 décembre 2024

Dates d'inscription aux études

Première soumission

17 mars 2022

Première soumission répondant aux critères de contrôle qualité

26 mars 2022

Première publication (Réel)

31 mars 2022

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

31 mars 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

26 mars 2022

Dernière vérification

1 mars 2022

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • Adherence to medication in DM

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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