Multilevel Ecological and COM-B Determinants of Medication Adherence in Adults With Diabetes (ADHECOM)

February 12, 2026 updated by: Dr. Rajat Rana, University of Malaya

Multilevel Ecological Determinants of Medication Adherence Among Diabetes Patients: A Health Ecology-COM-B Framework Analysis

This observational study aims to understand why some adults with diabetes find it difficult to take their medicines as prescribed. Medication adherence is essential for controlling blood sugar levels and preventing complications, yet many patients face challenges that go beyond personal motivation.

The study will examine multiple factors that may influence medication-taking behavior, including patients' understanding of their medicines, beliefs about treatment, family and social support, communication with healthcare providers, and practical issues such as medicine cost, availability, and distance to care. These factors will be analyzed using a structured behavioral framework to better understand how capability, opportunity, and motivation contribute to adherence.

By identifying the most important barriers and supports across different levels, this research aims to provide evidence that can guide patient-centered care strategies and improve medication adherence in diabetes management.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
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

This study is a cross-sectional, observational investigation designed to examine multilevel determinants of medication adherence among adults with diabetes using an integrated Health Ecology and Capability-Opportunity-Motivation-Behavior (COM-B) theoretical framework. The study is grounded in the premise that medication adherence is a complex health behavior shaped by interacting contextual and behavioral mechanisms rather than solely by individual patient choice.

From an ecological perspective, medication-taking behavior occurs within nested environments that include intrapersonal characteristics, interpersonal relationships, healthcare interactions, and broader structural or access-related conditions. Individual-level influences include cognitive and perceptual factors that shape how patients understand and interpret medication-related information. Interpersonal influences include family involvement and social support structures that may facilitate or hinder routine medicine-taking. Healthcare interaction-level determinants reflect the quality of communication between patients and healthcare providers, including clarity of explanations and comprehensibility of prescriptions. Structural and access-related determinants encompass practical constraints such as medication availability, affordability, geographic access to care, and regimen complexity.

While ecological models provide contextual organization of determinants, they do not fully explain how these determinants translate into observable behavior. Therefore, this study incorporates the COM-B framework to provide a mechanistic explanation. According to COM-B, behavior occurs when three essential components are present: psychological and physical capability, social and physical opportunity, and reflective and automatic motivation. Within the integrated framework used in this study, ecological determinants are mapped onto COM-B domains to examine how contextual influences operate through behavioral mechanisms to shape medication adherence.

Data will be collected during a single outpatient encounter using structured, validated self-report instruments and prescription audit methods. Medication adherence will be assessed using a standardized adherence scale. Measures representing ecological determinants will capture literacy-related capability, beliefs and perceptions influencing motivation, interpersonal and social support influencing social opportunity, communication quality influencing capability and opportunity, and structural or access-related constraints influencing physical opportunity. No intervention will be delivered, and no follow-up assessments will occur.

The analytical strategy is theory-guided. Descriptive statistics will summarize adherence levels and determinant distributions. Bivariate analyses will explore associations between adherence and individual predictors. Hierarchical multivariable regression models will be constructed sequentially according to COM-B domains to quantify their relative contribution to explained variance in adherence behavior. Mediation analyses will examine whether capability, opportunity, and motivation domains statistically account for the relationship between ecological determinants and adherence outcomes.

The study is designed to generate empirically grounded, theory-informed evidence clarifying which contextual layers and behavioral mechanisms are most strongly associated with medication adherence in diabetes care. By integrating ecological breadth with behavioral specificity, the findings are expected to support development of future pharmacist-led and health system-level strategies targeting modifiable determinants of adherence in resource-constrained settings.

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.
Observational

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.
220

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 Contact Backup

Study Locations

  • India
    • Haryana
      • Ambāla, Haryana, India
        • Recruiting
        • MM Superspeciality Hospital, Maharishi Markandeshwar (Deemed to be University)
        • Contact:
        • Contact:
          • Ananya Dr
        • Principal Investigator:
          • Rajat Rana
        • Sub-Investigator:
          • Jyoti Jain
        • Sub-Investigator:
          • Kanika Dr
        • Sub-Investigator:
          • Ananya Dr

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult patients receiving routine outpatient care for diabetes at a tertiary-care teaching hospital in North India. Participants are recruited from specialty outpatient clinics managing chronic disease pharmacotherapy. The source population represents individuals undergoing long-term medical management within a structured hospital-based care setting.

Description

Inclusion Criteria:

  • Adults aged 18 years or older
  • Diagnosed with at least one chronic disease (e.g., diabetes mellitus, hypertension, cardiovascular disease, chronic respiratory disease, chronic kidney disease) for a minimum duration of six months
  • Prescribed long-term medication therapy
  • Able to understand and respond to the study questionnaire
  • Willing to provide written informed consent

Exclusion Criteria:

  • Patients with acute medical conditions requiring immediate care
  • Individuals with severe cognitive impairment or psychiatric illness that would preclude reliable participation
  • Patients who are terminally ill
  • Patients unwilling to participate or provide consent

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Adults With Diabetes Receiving Long-Term Pharmacotherapy
This group includes adult outpatients with diagnosed diabetes who are receiving long-term pharmacotherapy and attending routine follow-up care at a tertiary-care teaching hospital. Participants will complete structured questionnaires assessing medication adherence and multilevel determinants mapped to capability, opportunity, and motivation domains. Prescription records will be reviewed to assess regimen complexity. No intervention will be delivered, and no follow-up assessments will occur.
Other: Multilevel Ecological Determinants of Medication Adherence
Assessment of contextual and behavioral determinants associated with medication adherence among adults with diabetes receiving routine clinical care. Determinants include individual-level factors (medication literacy, beliefs about medicines), interpersonal factors (family involvement, social support), healthcare interaction factors (communication quality, regimen complexity), and structural/access-related factors (availability, affordability, distance). These exposures are measured through validated questionnaires and prescription review during a single outpatient encounter. No intervention is assigned as part of the study.
Other Names:
  • Health Ecology-COM-B Determinants Framework

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
Medication Adherence
Time Frame: Single assessment at enrollment (Day 1)
Medication adherence assessed using the 12-item Adherence to Refills and Medications Scale (ARMS-12). Total scores range from 12 to 48, with higher scores indicating lower adherence.
Single assessment at enrollment (Day 1)

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
Medication Literacy
Time Frame: Single assessment at enrollment (Day 1)
Medication literacy assessed using the Single Item Literacy Screener (SILS), evaluating the need for assistance in reading medical instructions.
Single assessment at enrollment (Day 1)
Beliefs About Medicines
Time Frame: Single assessment at enrollment (Day 1)
Reflective motivation assessed using the Beliefs about Medicines Questionnaire (BMQ-Specific), measuring necessity and concern beliefs regarding prescribed medicines.
Single assessment at enrollment (Day 1)
Family Involvement in Medication Management
Time Frame: Single assessment at enrollment (Day 1)
Level of family participation in medication management categorized by degree of responsibility sharing.
Single assessment at enrollment (Day 1)
Perceived Social Support
Time Frame: Single assessment at enrollment (Day 1)
Social opportunity assessed using the Medical Outcomes Study Social Support Survey (MOS-SSS)
Single assessment at enrollment (Day 1)
Quality of Medication-Related Communication
Time Frame: Single assessment at enrollment (Day 1)
Healthcare interaction quality measured using selected items from the Communication Assessment Tool (CAT).
Single assessment at enrollment (Day 1)

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 Malaya

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Maharishi Markendeswar University (Deemed to be University)

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.
  • Principal Investigator: Rajat Rana, PhD, Universiti Malaya

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 (Actual)

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.
December 15, 2025

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 30, 2026

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.
August 30, 2026

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).
February 12, 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.
February 12, 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.
February 19, 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.
February 19, 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.
February 12, 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.
February 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.
  • IEC3618

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to institutional data governance policies and the protection of participant confidentiality. The study involves survey-based data collected in a single-center hospital setting, and de-identified datasets may still carry a risk of indirect identification. Aggregate results will be reported in publications and presentations. Any future data-sharing considerations would require additional data protection safeguards.

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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