Diabetes MellitusADHECOMNCT07420634
Multilevel Ecological and COM-B Determinants of Medication Adherence in Adults With Diabetes
An observational study of Diabetes Mellitus and Diabetes Mellitus Type 2, run by University of Malaya at 1 site in India.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Diabetes Mellitus Type 2, Medication Adherence
- What is being tested?
- Multilevel Ecological Determinants of Medication Adherence
- How many people
- 220 participants
- Where
- 1 siteIndia
- Study dates
- 15 Dec 2025to 30 Aug 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
MM Superspeciality Hospital, Maharishi Markandeshwar (Deemed to be University)
Ambāla, Haryana
Kanika Dr, 01731 304 100, rajat.rana@um.edu.my
Ananya Dr
About this study
Official title: 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.
Read the 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.
- Being tested
- Multilevel Ecological Determinants of Medication Adherence
- Keywords
- Health Ecology Model, COM-B Model, Medication Adherence, Diabetes Mellitus, Capability Opportunity Motivation, Behavioral Determinants, Medication Literacy
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multilevel Ecological Determinants of Medication AdherenceOther
Also called Health Ecology-COM-B Determinants Framework
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Multilevel Ecological Determinants of Medication Adherence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Adherence
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.
Measured: Single assessment at enrollment (Day 1)
Secondary outcomes (5)
Medication Literacy
Medication literacy assessed using the Single Item Literacy Screener (SILS), evaluating the need for assistance in reading medical instructions.
Measured: Single assessment at enrollment (Day 1)
Beliefs About Medicines
Reflective motivation assessed using the Beliefs about Medicines Questionnaire (BMQ-Specific), measuring necessity and concern beliefs regarding prescribed medicines.
Measured: Single assessment at enrollment (Day 1)
Family Involvement in Medication Management
Level of family participation in medication management categorized by degree of responsibility sharing.
Measured: Single assessment at enrollment (Day 1)
Perceived Social Support
Social opportunity assessed using the Medical Outcomes Study Social Support Survey (MOS-SSS)
Measured: Single assessment at enrollment (Day 1)
Quality of Medication-Related Communication
Healthcare interaction quality measured using selected items from the Communication Assessment Tool (CAT).
Measured: Single assessment at enrollment (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start15 Dec 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 220 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Collaborators
- Maharishi Markendeswar University (Deemed to be University)
- Responsible party
- Principal investigator, Dr. Rajat Rana, University of Malaya
- Investigators
- Rajat Rana, PhD, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07420634
- Sponsor's protocol ID
- IEC3618
- Acronym
- ADHECOM
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multilevel Ecological Determinants of Medication Adherence Among Diabetes Patients: A Health Ecology-COM-B Framework Analysis
- ClinicalTrials.gov ID
- NCT07420634
- Acronym / sponsor ID
- ADHECOM / IEC3618
- Keywords
- Health Ecology Model, COM-B Model, Medication Adherence, Diabetes Mellitus, Capability Opportunity Motivation, Behavioral Determinants, Medication Literacy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Collaborators
- Maharishi Markendeswar University (Deemed to be University)
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults With Diabetes Receiving Long-Term Pharmacotherapy | – | Other: Multilevel Ecological Determinants of Medication AdherenceThis 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multilevel Ecological Determinants of Medication AdherenceAlso: Health Ecology-COM-B Determinants FrameworkAssessment 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 | Adults With Diabetes Receiving Long-Term Pharmacotherapy |
Primary outcome
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.
5 secondary outcomes
Medication Literacy
Time frame: Single assessment at enrollment (Day 1)
Beliefs About Medicines
Time frame: Single assessment at enrollment (Day 1)
Family Involvement in Medication Management
Time frame: Single assessment at enrollment (Day 1)
Perceived Social Support
Time frame: Single assessment at enrollment (Day 1)
Quality of Medication-Related Communication
Time frame: Single assessment at enrollment (Day 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rajat Rana, PhD principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Diabetes Mellitus Type 2, run by University of Malaya at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rajat Rana, PhD (+91-9876543210, rajatrana91@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Adherence (time frame: Single assessment at enrollment (Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026; AzTrials last refreshed its copy on 6 Nov 2026.