Diabetes MellitusNCT02115412
Validation of Medication Non-adherence Model (UK)
An observational study of Diabetes Mellitus and Chronic Obstructive Pulmonary Disease, run by Philips Healthcare at 4 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Diabetes Mellitus, Chronic Obstructive Pulmonary Disease, Chronic Illness
- How many people
- 750 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- Jul 2014to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with chronic illness taking more than 3 medications. These patients will be between the age of 18 - 89
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Swan Lane Medical Centre
Bolton, Greater Manchester, BL3 6TL
Rosedale Surgery
Carlton Colville, Lowestoft, Suffolk, NR33 8LG
Vida Health, 39 Gayton Road
Kings Lynn, Norfolk, PE30 4DY
Wymondham Medical Practice
Norfolk, NR18 ORF
About this study
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.
- Conditions
- Diabetes Mellitus, Chronic Obstructive Pulmonary Disease, Chronic Illness, Primary Care, Medication Management at Home
- Medical subject headings
- Diabetes Mellitus, Pulmonary Disease, Chronic Obstructive, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| medication non-adherence | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence determinants
Self-reported behavioral questionnaire completed at 3 monthly intervals
Measured: 6 months
Secondary outcomes (1)
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
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2015
- Study completionDec 2015
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.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02115412
- Sponsor's protocol ID
- PhilipsResearch-2007-0116
- Status last verified
- Sep 2020
- First submitted
- 14 Apr 2014
- Last updated
- 29 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Medication Non-adherence Model (UK)
- ClinicalTrials.gov ID
- NCT02115412
- Acronym / sponsor ID
- PhilipsResearch-2007-0116
- Conditions
- Diabetes Mellitus, Chronic Obstructive Pulmonary Disease, Chronic Illness, Primary Care, Medication Management at Home
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Philips HealthcareIndustry (pharma, biotech, devices)
- Study start
- Jul 2014 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 16 Apr 2014 (estimated)
- 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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| medication non-adherence | – | – |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with chronic illness taking more than 3 medications. These patients will be between the age of 18 - 89
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adherence determinants
Time frame: 6 months
Self-reported behavioral questionnaire completed at 3 monthly intervals
1 secondary outcome
Medication usage
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites 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 Chronic Obstructive Pulmonary Disease, run by Philips Healthcare at 4 sites in United Kingdom.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 29 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence determinants (time frame: 6 months). 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 29 Sep 2020.