A Nurse-Led Personalized Self-Management Counseling Intervention to Improve Medication Adherence and Glycemic Control in Adults With Type 2 Diabetes: A Randomized Controlled Trial (SMCI)

Background and Rationale

Medication adherence is an important component of diabetes management. Adults with type 2 diabetes may experience different barriers to taking medications as prescribed, including forgetfulness, medication-related beliefs and concerns, perceived adverse effects, low motivation, regimen complexity, difficulties integrating medication use into daily routines, limited access to medications, and inadequate social support. A standardized counseling approach may not adequately address the different needs of individual patients.

Nurse-led counseling can provide structured education, identify patient-specific barriers, and support practical strategies for medication-taking behavior. Personalizing counseling according to the main barrier experienced by each participant may improve the relevance and usefulness of the intervention.

Study Objective

The primary objective is to evaluate the effectiveness of a personalized nurse-led counseling intervention in improving medication adherence among adults with type 2 diabetes compared with usual care.

A secondary objective is to evaluate the effect of the intervention on glycemic control, measured by glycated hemoglobin (HbA1c). Additional secondary outcomes may include diabetes self-management, medication-related self-efficacy, and other outcomes specified in the final study protocol.

Study Design

This study will use a randomized controlled trial design with an intervention group and a usual-care control group. Eligible participants will be randomly allocated to one of the two study groups according to a prespecified randomization procedure.

Study Population

The study population will consist of adults diagnosed with type 2 diabetes who meet the eligibility criteria specified in the approved study protocol. Participants will be recruited from the designated study setting. Written informed consent will be obtained before enrollment and before study-specific data collection.

Intervention

Participants assigned to the intervention group will receive a structured, individualized, nurse-led counseling program delivered over five consecutive days. Each session is planned to last approximately 30-40 minutes, subject to the final intervention protocol.

The intervention will include the following components:

1. Initial assessment: Establishing rapport, assessing medication-taking practices, identifying barriers to adherence, and setting an initial individualized goal.
2. Core medication-adherence education: Discussing the importance of following the prescribed medication regimen and selecting practical strategies to support regular medication use.
3. Personalized counseling: Addressing the participant's main identified barrier. Potential modules will cover forgetfulness, medication beliefs and concerns, perceived side effects, motivation and self-efficacy, regimen complexity and daily routines, and medication access or social support.
4. Problem-solving and self-management: Helping participants anticipate challenges, identify feasible solutions, and develop strategies to maintain medication-taking routines.
5. Consolidation and action planning: Reviewing progress, agreeing on a specific and achievable goal, preparing a personal action plan, and using teach-back to assess understanding.

The intervention will not replace prescribed medical treatment. Participants will be advised to consult their treating clinician regarding medication changes or suspected adverse effects. Nurses will not independently change medication doses or discontinue prescribed medications.

Control Group

Participants allocated to the control group will receive usual diabetes care available at the study site. Usual care will be described in the study protocol, including routine clinical consultations, medication management, and any standard education normally provided. Additional counseling beyond usual care will not be introduced as part of the study intervention for this group.

Outcome Measures

The primary outcome will be medication adherence, assessed using the prespecified medication-adherence instrument. The instrument, scoring procedure, assessment time points, and any required permissions will be finalized before recruitment.

A key secondary outcome will be glycemic control, assessed using HbA1c. Other secondary outcomes, if included in the final protocol, will be measured using prespecified instruments and procedures.

Assessments are planned at baseline, Week 4, and Week 12, subject to confirmation in the final protocol. The timing of HbA1c measurements will be specified in accordance with the study objectives and the expected biological response to the intervention.

Data Analysis

Participant characteristics and baseline outcomes will be summarized using appropriate descriptive statistics. Between-group differences in medication adherence and HbA1c will be analyzed using statistical methods appropriate to the outcome distributions, study design, and repeated measurements. The final statistical analysis plan will specify the primary estimand, handling of missing data, covariate adjustment, significance level, and reporting of effect estimates with confidence intervals.

Ethical Considerations

The study will be conducted in accordance with applicable ethical principles and institutional requirements. Approval from the relevant research ethics committee will be obtained before recruitment and study-specific procedures begin. Written informed consent will be obtained from all participants. Personal information will be handled confidentially, and participation will be voluntary. Participants may withdraw from the study in accordance with the consent process and applicable requirements.