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NCT02115412 Clinical Trial

Validation of Medication Non-adherence Model (UK)

Diabetes Mellitus Clinical Trial

Official title:
Validation of Medication Non-adherence Model (UK)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02115412
Other study ID # PhilipsResearch-2007-0116
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 2014
Est. completion date December 2015

Study information
Verified date September 2020
Source Philips Healthcare
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Research has shown that nearly 50% of patients with chronic conditions around the globe do not adhere to their prescribed medicine, leading to enormous cost to the healthcare providers. Non-adherence can be due to various forms and have multiple causes.

To address this need, Philips Research has developed Medication Non-adherence model. This tool will help in developing a systemic way of assessing medication non-adherence and providing decision support for targeted intervention to healthcare professionals. The aim of this study is to validate this model with 750 chronically ill patients in UK.

Recruitment information / eligibility
Status Completed
Enrollment 750
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 89 Years
Eligibility Inclusion Criteria:

- Patients with chronic disease between 18 -89 years old.

- Chronic medication use (> 3 medications; excluding analgesic, ointment and eye drop medication)

- Patients registered with a given Pharmacy at least 1 year before entering into the study.

Exclusion Criteria:

- Patients who are illiterate in English.

- Patients who are unable to give consent to the study.

- Enrolled in another clinical trial, which requires change in their routinely medication.

- Patients currently using automatic medication reminder services (excluding the pharmacy service).

- Patients with dementia or any other mental conditions, that might affects the accuracy of the answers provided.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom Swan Lane Medical Centre Bolton Greater Manchester
United Kingdom Rosedale Surgery Carlton Colville, Lowestoft Suffolk
United Kingdom Vida Health, 39 Gayton Road King's Lynn Norfolk
United Kingdom Wymondham Medical Practice Norfolk

Sponsors (1)
Lead Sponsor Collaborator
Philips Healthcare

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Other Adverse Events Any adverse events (eg: hospitalisation, elective surgeries), which may have resulted change in their daily medication routine Time Frame: 18 months, meaning 12 month prior to enrollment + 6 months during the study 18 months
Primary Adherence determinants Self-reported behavioral questionnaire completed at 3 monthly intervals 6 months
Secondary Medication usage Collecting refill data from the pharmacy where patients are registered to. Time Frame: 18 months (12 month prior to enrollment + 6 months during the study 18 months
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