Diabetes Distress, Medication Adherence Barriers, Self-Management, and Glycemic Control in Adults With Type 2 Diabetes

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBilecik Seyh Edebali Universitesi

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

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.

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

  • Diabetes Distress

    Other intervention

    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.

  • Medication Adherence Barriers

    Other intervention

    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-managemen

    Other intervention

    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.

Treatment groups

137 Participants
are divided into 1 treatment group
Group A: Adults With Type 2 Diabetes Mellitus3 interventions

Trial outcomes

Primary outcomes

1

Glycemic control measured by glycated hemoglobin (HbA1c)

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.

Time frame
At study enrollment; the most recent HbA1c result measured within the previous 3 months.

Secondary outcomes

1

Mean score on the 17-item Diabetes Distress Scale

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.

Time frame
Once at study enrollment.
2

Total score on the Medication Practical Barriers to Adherence Questionnaire

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.

Time frame
Once at study enrollment
3

Diabetes self-management score

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.

Time frame
Once at study enrollment

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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