Multilevel Ecological and COM-B Determinants of Medication Adherence in Adults With Diabetes
ADHECOM
Multilevel Ecological Determinants of Medication Adherence Among Diabetes Patients: A Health Ecology-COM-B Framework Analysis
1 other identifier
observational
220
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2025
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 15, 2025
CompletedFirst Submitted
Initial submission to the registry
February 12, 2026
CompletedFirst Posted
Study publicly available on registry
February 19, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2026
ExpectedFebruary 19, 2026
February 1, 2026
7 months
February 12, 2026
February 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Single assessment at enrollment (Day 1)
Secondary Outcomes (5)
Medication Literacy
Single assessment at enrollment (Day 1)
Beliefs About Medicines
Single assessment at enrollment (Day 1)
Family Involvement in Medication Management
Single assessment at enrollment (Day 1)
Perceived Social Support
Single assessment at enrollment (Day 1)
Quality of Medication-Related Communication
Single assessment at enrollment (Day 1)
Study Arms (1)
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.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
MM Superspeciality Hospital, Maharishi Markandeshwar (Deemed to be University)
Ambāla, Haryana, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rajat Rana, PhD
Universiti Malaya
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Researcher
Study Record Dates
First Submitted
February 12, 2026
First Posted
February 19, 2026
Study Start
December 15, 2025
Primary Completion
June 30, 2026
Study Completion (Estimated)
August 30, 2026
Last Updated
February 19, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share
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.