Multilevel Ecological and COM-B Determinants of Medication Adherence in Adults With Diabetes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorUniversity of Malaya
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 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.
Trial design
Design model
Case-only
Time perspective
Cross-sectional
Treatments tested in this trial
Multilevel Ecological Determinants of Medication Adherence
Other interventionAssessment 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.
Treatment groups
220 Participants
are divided into 1 treatment groupGroup A: Adults With Diabetes Receiving Long-Term Pharmacotherapy1 intervention
Trial outcomes
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.
Time frame
Single assessment at enrollment (Day 1)Secondary outcomes
1
Medication Literacy
Medication literacy assessed using the Single Item Literacy Screener (SILS), evaluating the need for assistance in reading medical instructions.
Time frame
Single assessment at enrollment (Day 1)2
Beliefs About Medicines
Reflective motivation assessed using the Beliefs about Medicines Questionnaire (BMQ-Specific), measuring necessity and concern beliefs regarding prescribed medicines.
Time frame
Single assessment at enrollment (Day 1)3
Family Involvement in Medication Management
Level of family participation in medication management categorized by degree of responsibility sharing.
Time frame
Single assessment at enrollment (Day 1)4
Perceived Social Support
Social opportunity assessed using the Medical Outcomes Study Social Support Survey (MOS-SSS)
Time frame
Single assessment at enrollment (Day 1)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Malaya
Lead sponsor
Maharishi Markendeswar University (Deemed to be University)
Collaborator
Source ClinicalTrials.gov