An interventional study of Nurse-Led Personalized Self-Management Counseling in Medication Adherence and Glycemic Control for Diabetes Mellitus, sponsored by University of Basrah. Not yet recruiting at 1 site in Iraq. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by University of Basrah · Not applicable, Interventional, and Treatment
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.
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:
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.
937 studies on the registry are indexed under Medication Adherence; 159 are open to participants now.
This study's planned enrollment of 128 is close to the median of 120 across 768 interventional studies indexed under Medication Adherence.
Browse Medication Adherence studies →University of Basrah is the lead sponsor of 8 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
**Study Population**
The study will include adult patients with type 2 diabetes mellitus receiving routine diabetes care at the selected study setting.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
Change in Medication Adherence Score from Baseline to Follow-Up
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.
Time frame: Baseline and 12 weeks after the intervention.
Change in Glycated Hemoglobin (HbA1c) Level from Baseline to 12 Weeks
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.
Time frame: Baseline and 12 weeks after the intervention.
Change in Diabetes Self-Management Behavior Score from Baseline to 12 Weeks
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.
Time frame: Baseline and 12 weeks after the intervention
Plan to share: No — 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.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Jun 2027, 7 months later.
Of 425 non-industry interventional studies with no phase under Medication Adherence, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 42. This study's planned 7 months is below that.
Counting every sponsor, half of 442 studies reached it within 21 months; a quarter within 11 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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University of Basrah