Diabetes Distress, Medication Adherence Barriers, Self-Management, and Glycemic Control in Adults With Type 2 Diabetes
The Mediating Role of Diabetes Self-Management in the Relationship Between Diabetes Distress, Medication Adherence Barriers, and Glycemic Control Among Patients With Type 2 Diabetes
This observational study will examine the relationships among diabetes distress, practical barriers to medication use, diabetes self-management, and glycemic control in adults with type 2 diabetes. Participants who meet the study criteria and agree to take part will complete questionnaires about their personal and clinical characteristics, diabetes distress, medication-taking barriers, and diabetes self-management. With their permission, the most recent HbA1c result measured within the previous three months will be obtained from their medical record. No treatment or medication changes will be made for this study. The researchers plan to include at least 137 participants.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This single-center, cross-sectional observational study will be conducted at the Diabetes Nursing Unit of Bozüyük State Hospital in Bilecik, Türkiye. The study will examine whether diabetes self-management statistically mediates the relationships between diabetes distress and glycemic control, and between practical medication adherence barriers and glycemic control, as measured by HbA1c.
Adults aged 18 years or older with a diagnosis of type 2 diabetes for at least six months, receiving oral antidiabetic medication and/or insulin, and with an HbA1c result measured within the previous three months will be eligible. Participants must be able to communicate in Turkish and provide informed consent. Individuals with type 1 or gestational diabetes, those unable to complete the questionnaires because of cognitive or other serious communication difficulties, and those without a recent HbA1c result will be excluded.
Data will be collected once through a personal information form, the Diabetes Distress Scale, the Medication Practical Barriers to Adherence Questionnaire, and the Type 2 Diabetes Self-Management Scale. The most recent HbA1c result will be obtained from the participant's medical record or hospital information system with permission. Completing the study forms is expected to take approximately 15-20 minutes. No intervention will be provided, and participants' usual care will not be changed. The planned sample size is at least 137 participants.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Burcu Bayrak Kahraman, PhD
- Numéro de téléphone: +905057542411
- E-mail: burcu.bayrak@bilecik.edu.tr
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
Adults with type 2 diabetes mellitus who attend the Diabetes Nursing Unit of Bozüyük State Hospital in Bilecik, Türkiye, have had type 2 diabetes for at least six months, and meet the study eligibility criteria.
La description
Inclusion Criteria:
- Age 18 years or older.
- Diagnosis of type 2 diabetes mellitus for at least six months.
- Attending the Diabetes Nursing Unit.
- Using oral antidiabetic medication and/or insulin.
- Having an HbA1c result measured within the previous three months.
- Able to communicate in Turkish.
- Voluntarily agrees to participate in the study.
Exclusion Criteria:
- Diagnosis of type 1 diabetes mellitus or gestational diabetes.
- No HbA1c result measured within the previous three months, or the result is unavailable.
- Withdraws from the study.
- Study forms are substantially incomplete.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: OTHER
- Perspectives temporelles: CROSS_SECTIONAL
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Adults With Type 2 Diabetes Mellitus
Adults aged 18 years or older with type 2 diabetes for at least 6 months who meet the study eligibility criteria. All participants will be assessed in a single group. |
Diabetes distress will be assessed once using the 17-item Diabetes Distress Scale (DDS). No intervention will be assigned, and participants' usual diabetes care will not be changed. Practical barriers to medication adherence will be assessed once using the 15-item Medication Practical Barriers to Adherence Questionnaire. No intervention will be assigned, and participants' usual diabetes care will not be changed. Diabetes self-management will be assessed once using the 19-item Type 2 Diabetes Self-Management Scale. No intervention will be assigned, and participants' usual diabetes care will not be changed. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Glycemic control measured by glycated hemoglobin (HbA1c)
Délai: At study enrollment; the most recent HbA1c result measured within the previous 3 months.
|
The primary outcome is glycemic control, assessed by the most recent HbA1c result recorded within 3 months before enrollment. With permission, HbA1c will be obtained from the participant's medical record or hospital information system. Cross-sectional associations of HbA1c with diabetes distress and medication adherence barriers, and the statistical mediating role of diabetes self-management in these relationships, will be examined. |
At study enrollment; the most recent HbA1c result measured within the previous 3 months.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Mean score on the 17-item Diabetes Distress Scale
Délai: Once at study enrollment.
|
Diabetes distress will be measured using the 17-item Diabetes Distress Scale (DDS). Each item is rated from 1 to 6, and the overall score is calculated as the mean of the 17 item scores, resulting in a score range of 1 to 6. Higher scores indicate greater diabetes distress (a worse outcome). The score will be analyzed in relation to HbA1c and diabetes self-management. |
Once at study enrollment.
|
|
Total score on the Medication Practical Barriers to Adherence Questionnaire
Délai: Once at study enrollment
|
Practical barriers to medication adherence will be assessed using the 15-item Medication Practical Barriers to Adherence Questionnaire (MPRAQ). Each item is rated on a 5-point Likert scale. The total score ranges from 15 (minimum) to 75 (maximum). Higher scores indicate greater practical barriers to medication adherence (a worse outcome). The score will be analyzed in relation to HbA1c and diabetes self-management. |
Once at study enrollment
|
|
Diabetes self-management score
Délai: Once at study enrollment
|
Diabetes self-management will be assessed using the 19-item Type 2 Diabetes Self-Management Scale. Its statistical mediating role in the relationships of diabetes distress and medication adherence barriers with HbA1c will be examined. |
Once at study enrollment
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies du système endocrinien
- Maladies métaboliques
- Troubles du métabolisme du glucose
- Diabète sucré
- Comportement
- Maladies nutritionnelles et métaboliques
- Adhésion et conformité au traitement
- Comportement de santé
- L'observance du patient
- Acceptation des soins de santé par le patient
- Diabète sucré, Type 2
- Adhésion aux médicaments
Autres numéros d'identification d'étude
- T2DM-DSM-2026
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
No individual participant data (IPD) will be shared with other researchers. The study protocol does not include an IPD-sharing plan. Participant confidentiality will be protected, and only aggregate study findings may be reported in publications.
Informations sur les médicaments et les dispositifs, documents d'étude
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