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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Burcu Bayrak Kahraman, PhD
- Número de teléfono: +905057542411
- Correo electrónico: burcu.bayrak@bilecik.edu.tr
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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.
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: OTHER
- Perspectivas temporales: CROSS_SECTIONAL
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Glycemic control measured by glycated hemoglobin (HbA1c)
Periodo de tiempo: 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.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mean score on the 17-item Diabetes Distress Scale
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del sistema endocrino
- Enfermedades metabólicas
- Trastornos del metabolismo de la glucosa
- Diabetes mellitus
- Comportamiento
- Enfermedades Nutricionales y Metabólicas
- Adherencia y Cumplimiento del Tratamiento
- Comportamiento de salud
- Cumplimiento del paciente
- Aceptación del paciente de la atención médica
- Diabetes Mellitus, Tipo 2
- Adherencia a la medicación
Otros números de identificación del estudio
- T2DM-DSM-2026
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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