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)

October 31, 2026 updated by: Ali Malik Tiryag, University of Basrah

T2D is a chronic disease that forces people with diabetes to take their medications as prescribed and adhere to the recommended self-care practices to control their blood sugar and prevent complications. For a few patients, however, poor medication adherence is a problem due to forgetfulness, medication concerns, side effects, scheduling of medications in daily life, lack of access to medication, or lack of social support.

Researchers want to see whether a customized nurse-led counseling service is effective in enhancing adherence to diabetes medications for adults with type 2 diabetes in a randomized controlled trial. The study will also explore the impact of the intervention on glycated hemoglobin (HbA1c) levels when compared to usual care.

Participants who meet the criteria will be randomly assigned to either an intervention group or a usual care control group. Intervention group will be given a structured nurse-led counseling program, tailored to them, for 5 consecutive days. Assessment of medication taking barriers, providing education on medication adherence, problem solving strategies, individual goal setting, and development of a personal action plan will be incorporated into the program. A primary identified barrier to medication adherence will be identified and used to guide the counseling provided.

The participants in the control group will be provided with standard diabetes care, as provided by the study site's services. Prespecified outcomes will be measured at baseline and at follow-up, including adherence to medication. HbA1c will be determined per study protocol to assess glycemic control.

The results could guide the potential for a brief, individualized nurse-led counselling program as a feasible intervention for promoting adherence to treatment and self-management of diabetes in adults with type 2 diabetes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
128

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Iraq
    • Basrah
      • Basra, Basrah, Iraq, 61004
        • College of Nursing, University of Basrah
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  1. Adults aged 18 years or older.
  2. Individuals with a confirmed medical diagnosis of type 2 diabetes mellitus.
  3. Individuals currently receiving prescribed pharmacological treatment for type 2 diabetes mellitus (oral antidiabetic medications and/or injectable glucose-lowering medications).
  4. Individuals who are able to communicate effectively with the research team.
  5. Individuals who are willing and able to provide written informed consent.
  6. Individuals who are available to participate in the counseling intervention and complete the scheduled follow-up assessments.

Exclusion Criteria

  1. Individuals diagnosed with type 1 diabetes mellitus or gestational diabetes.
  2. Individuals with severe cognitive or communication impairments that prevent participation in the counseling intervention or completion of study assessments.
  3. Individuals with an acute medical condition requiring hospitalization at the time of recruitment.
  4. Individuals currently participating in another structured diabetes self-management intervention or clinical trial that may interfere with the study outcomes.
  5. Individuals who are unable to complete the planned follow-up assessments.

**Study Population**

The study will include adult patients with type 2 diabetes mellitus receiving routine diabetes care at the selected study setting.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Nurse-Led Personalized Self-Management Counseling Group

Participants will receive a structured, nurse-led personalized self-management counseling intervention designed to improve medication adherence and glycemic control. The intervention will address individual barriers to medication adherence, diabetes self-management practices, and strategies for improving adherence to prescribed treatment recommendations
Behavioral: Nurse-Led Personalized Self-Management Counseling

A structured, nurse-led personalized self-management counseling program designed for adults with type 2 diabetes mellitus. The intervention includes individualized assessment of barriers to medication adherence, identification of self-management needs, personalized counseling, medication-taking strategies, goal setting, action planning, and teach-back to reinforce understanding and promote adherence to prescribed diabetes treatment. The intervention will be delivered over five consecutive days through individualized nurse-patient counseling sessions. Participants will also receive educational materials and personalized recommendations based on their identified needs.
No Intervention: Usual Care Control Group

Participants will receive the usual diabetes care provided at the study setting, including routine clinical consultations, standard diabetes education, and prescribed medical treatment, without receiving the additional structured nurse-led personalized counseling intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Medication Adherence Score from Baseline to Follow-Up
Time Frame: Baseline and 12 weeks after the intervention.

Medication adherence will be assessed using a validated medication adherence questionnaire. The total medication adherence score will be measured at baseline and follow-up. The change in score from baseline to follow-up will be compared between the intervention and control groups. Higher scores will indicate better medication adherence, according to the scoring instructions of the selected instrument.
Baseline and 12 weeks after the intervention.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Glycated Hemoglobin (HbA1c) Level from Baseline to 12 Weeks
Time Frame: Baseline and 12 weeks after the intervention.

Glycemic control will be assessed by measuring glycated hemoglobin (HbA1c) levels using laboratory testing. HbA1c levels will be measured at baseline and at 12 weeks after the intervention. The mean change in HbA1c levels will be compared between the intervention and control groups. Lower HbA1c levels indicate improved glycemic control.
Baseline and 12 weeks after the intervention.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Diabetes Self-Management Behavior Score from Baseline to 12 Weeks
Time Frame: Baseline and 12 weeks after the intervention

Diabetes self-management behaviors will be assessed using a validated diabetes self-management questionnaire. The total score will be measured at baseline and 12 weeks after the intervention to evaluate changes in participants' self-management practices.
Baseline and 12 weeks after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Basrah

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Ali M Tiryag, PhD, College of Nursing, University of Basrah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 20, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 25, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 31, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 5, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 3/7/1675

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared with other researchers because of participant confidentiality, privacy protection, and institutional ethical requirements. The study data will be used solely for the purposes specified in the approved research protocol.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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