Validation of Medication Non-adherence Model (UK)

September 25, 2020 updated by: Philips Healthcare

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

750

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Norfolk, United Kingdom, NR18 ORF
        • Wymondham Medical Practice
    • Greater Manchester
      • Bolton, Greater Manchester, United Kingdom, BL3 6TL
        • Swan Lane Medical Centre
    • Norfolk
      • King's Lynn, Norfolk, United Kingdom, PE30 4DY
        • Vida Health, 39 Gayton Road
    • Suffolk
      • Carlton Colville, Lowestoft, Suffolk, United Kingdom, NR33 8LG
        • Rosedale Surgery

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

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with chronic illness taking more than 3 medications. These patients will be between the age of 18 - 89

Description

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 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
medication non-adherence

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence determinants
Time Frame: 6 months
Self-reported behavioral questionnaire completed at 3 monthly intervals
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication usage
Time Frame: 18 months
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 18 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philips Healthcare

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)

July 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

April 14, 2014

First Submitted That Met QC Criteria

April 14, 2014

First Posted (Estimate)

April 16, 2014

Study Record Updates

Last Update Posted (Actual)

September 29, 2020

Last Update Submitted That Met QC Criteria

September 25, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PhilipsResearch-2007-0116

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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