PolypharmacyNCT04663360
Medication Monitoring for Older Adults in Primary Care
A study testing Adverse Drug Reaction (ADRe) Profile in people with Polypharmacy, run by Swansea University at 1 site in United Kingdom.
Trial summary
Polypharmacy has the potential to harm older adults by causing cognitive impairment, falls, and hospitalisations. Many adverse drug reactions could be prevented with closer monitoring. Read more about this study
- Who is it for?
- Ages 64 years and older
- Conditions the study is for
- Polypharmacy
- What is being tested?
- Adverse Drug Reaction (ADRe) Profile
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Jan 2020to 4 Oct 2020
- Phase
- Interventional
- 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 64 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients:
- age > 64 years
- with a long-term condition
- prescribed > 5 medications daily. (Vitamin and nutritional supplements and moisturising skin preparations will not be counted as 'medicines'.)
- Willing and able to give informed, signed consent themselves, or where capacity is lacking in the opinion of their nurses, a consultee/representative accompanying the patient who is willing to give advice and assent to the service user participating and sign on their behalf.
Who cannot join
- Patients:
- Age < 64 years
- Without any long-term conditions
- Prescribed < 5 medications daily
- Not willing to participate
- Unable to consent and no consultee/representative present
Show all 9Show fewer
- Not fluent in English or Welsh (unless a family member can assist with translation)
- Receiving palliative care
- Expected to remain in the practice for the next 12 months
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Aneurin Bevan Health Board
Newport, Gwent, NP18 3XQ
About this study
Official title: Medication Monitoring in General Practice: Clinical Impact of Implementing a Nurse-led Adverse Drug Reaction (ADRe) Profile in Older Adults With 5 or More Prescribed Medicines
Polypharmacy has the potential to harm older adults by causing cognitive impairment, falls, and hospitalisations. Many adverse drug reactions could be prevented with closer monitoring. This project will establish the effectiveness of the nurse-led intervention - the ADRe Profile - for medicines commonly prescribed in primary care and evaluate intervention implementation in general practices.
Read the detailed description
The number of medicines people take is increasing. Older adults are particularly at risk of adverse drug reactions due to polypharmacy. Adverse drug reactions cause avoidable patient harm, and around 5-8% of unplanned hospital admissions in the UK, costing the NHS £1.5-2.5bn pa. Many adverse drug reactions could be prevented with closer monitoring. The nurse-led Adverse Drug Reactions Profile (ADRe Profile) represents a unique instrument that records patients' observations and self-reported information on signs and symptoms that is likely to relate to an adverse reaction to medications. This project will establish the effectiveness of ADRe Profile in identifying patient problems possibly resulting from medicines in general practices and will be implemented in 3 phases.
Phase 1 (4 months) Validity and reliability testing of the ADRe Profile will be performed with key stakeholders (patients, nurses, care assistants, GP's and pharmacists), before introducing the tool to general practices. Feasibility testing will also be undertaken.
Phase 2 (12 months) The aim of this phase is to test whether the ADRe Profile identifies and ameliorates health problems. The practice nurse (or the researcher) will perform an ADRe consultation with a group of eligible service users and compare the number and nature of health and well-being problems identified with a similar group of service users who receive normal care.
Phase 3 (6 months) Finally, to further explore the impact of the ADRe Profile, the researchers will conduct semi-structured interviews with health professionals (nurses, care assistants, GPs and pharmacists) and service users.
The investigators hope that this study will help patients gain maximum benefits from their medicines and support nurses, pharmacists and GP's to reduce any bothersome side effects and problems that, if not addressed promptly, can lead to hospital admissions.
- Conditions
- Polypharmacy
- Being tested
- Adverse Drug Reaction (ADRe) Profile
- Keywords
- medicines management, adverse drug reaction, nurses, primary care
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adverse Drug Reaction (ADRe) ProfileOther
ADRe asks nurses to systematically check patients for the manifestation of itemised adverse side effects or undesirable effects of their primary care medicines, as listed in the BNF and manufacturers' Summaries of Product Characteristics (SmPCs), and seminal texts documenting known ADRs. Nurses are asked to share the identified problems with prescribers and pharmacists overseeing medicines charts.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention to be administered: Adverse Drug Reactions (ADRe) Profile. asks nurses to systematically check patients for the manifestation of itemised adverse side effects or undesirable effects of their primary care medicines, as listed in the BNF and manufacturers' Summaries of Product Characteristics (SmPCs), and seminal texts documenting known ADRs. Nurses are asked to share the identified problems with prescribers and pharmacists overseeing medicines charts. Receives: Other: Adverse Drug Reaction (ADRe) Profile |
| Control | No intervention | Usual clinical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of completion of all items in the video call-completed ADRe Profile
Comparison of completeness of the ADRe Profile completed through a video call with ADRe Profiles previously completed in person
Measured: 4 months from the start of the study
Inter-rater reliability of patient versus nurse (or nurse-researcher) completed ADRe Profile (Cohen's Kappa).
To determine how much of the potential variability of the records is due to errors in measurement, to estimate a degree to which service users accurately evaluate their symptoms when compared with a nurse researcher. Cohen's Kappa will be calculated.
Measured: 4 months from the start of the study
Calculated percentage and described nature of items on the ADRe Profile that can be populated from accessing the nursing and medical notes.
Establishing the overlap of information - the number and nature of the ADRe items that have previously been collected and recorded in the patients' nursing and medical notes.
Measured: 16 months from the start of the study
Clinical impact on service users, including new problems identified (number and nature) and problems addressed (number and nature)
Number of patients with a change in signs and symptoms related to adverse effects of prescribed medicines. Care quality/ clinical gain/ benefit to patients as recorded in notes and on the Profile by the number and nature of all health problems addressed, particularly serious adverse events.
Measured: 16 months from the start of the study
Prescription changes
Number of patients with changes in prescription regimens: drug or dose. Number and nature of changes.
Measured: 16 months from the start of the study
Description of stakeholder views on ADRe Profile implementation effectiveness (survey rating of the ADRe Profile - Likert scale)
A brief survey will be distributed to the main stakeholders (patients, nurses, GP's and pharmacists) following completion of Randomised Controlled Trial.
Measured: 22 months from the start of the study
Description of stakeholder views on ADRe Profile implementation feasibility (eliciting interview themes)
Semi-structured interview with the main stakeholders (patients, nurses, GP's and pharmacists) to explore their views on feasibility of ADRe Profile integration in GP practices.
Measured: 22 months from the start of the study
Secondary outcomes (4)
Calculation of the average nurses', GP's and pharmacists' length of time per one ADRe Profile completion
Average length of the health professionals' time involvement with one ADRe Profile
Measured: 16 months from the start of the study
Calculation of the cost of nurses', GP's and pharmacists' time, based on average national salary cost per hour.
Estimated costs of ADRe implementation in GP practices
Measured: 16 months from the start of the study
Description of the main stakeholders' views on multidisciplinary collaboration (eliciting interview themes)
Semi-structured interview with the main stakeholders (patients, nurses, GP's and pharmacists) to explore their views on whether and how ADRe Profile contributed to multidisciplinary collaboration between nurses, doctors and pharmacists
Measured: 22 months from the start of the study
Description of the patients' views on the contribution of ADRe Profile to patient-centered care (eliciting interview themes).
Semi-structured interview with the patients to seek their views on whether and how ADRe Profile contributes to patient-centered care
Measured: 22 months from the start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start5 Jan 2020
- Primary completion31 May 2020
- Study completion4 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for PolypharmacyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participating GP practices will be randomised into an intervention and control arms.
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swansea University
- Sponsor type
- University, hospital or other
- Collaborators
- Abertawe Bro Morgannwg University Health Board, Hywel Dda Health Board
- Responsible party
- Sponsor
- Investigators
- Sue Jordan, PhD, Study chair, Swansea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04663360
- Sponsor's protocol ID
- Swansea Nursing
- Status last verified
- Nov 2020
- First submitted
- 26 Nov 2020
- Last updated
- 7 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gabe ME, Murphy F, Davies GA, Russell IT, Jordan S. Medication monitoring in a nurse-led respiratory outpatient clinic: pragmatic randomised trial of the West Wales Adverse Drug Reaction Profile. PLoS One. 2014 May 5;9(5):e96682. doi: 10.1371/journal.pone.0096682. eCollection 2014.
PubMed 24798210Jones R, Moyle C, Jordan S. Nurse-led medicines monitoring: a study examining the effects of the West Wales Adverse Drug Reaction Profile. Nurs Stand. 2016 Nov 30;31(14):42-53. doi: 10.7748/ns.2016.e10447.
PubMed 27902153Jordan S. Managing adverse drug reactions: an orphan task. J Adv Nurs. 2002 Jun;38(5):437-48. doi: 10.1046/j.1365-2648.2002.02205.x.
PubMed 12028277Jordan S, Tunnicliffe C, Sykes A. Minimizing side-effects: the clinical impact of nurse-administered 'side-effect' checklists. J Adv Nurs. 2002 Jan;37(2):155-65. doi: 10.1046/j.1365-2648.2002.02064.x.
PubMed 11851783Jordan S, Gabe M, Newson L, Snelgrove S, Panes G, Picek A, Russell IT, Dennis M. Medication monitoring for people with dementia in care homes: the feasibility and clinical impact of nurse-led monitoring. ScientificWorldJournal. 2014 Feb 23;2014:843621. doi: 10.1155/2014/843621. eCollection 2014.
PubMed 24707218Jordan S, Gabe-Walters ME, Watkins A, Humphreys I, Newson L, Snelgrove S, Dennis MS. Nurse-Led Medicines' Monitoring for Patients with Dementia in Care Homes: A Pragmatic Cohort Stepped Wedge Cluster Randomised Trial. PLoS One. 2015 Oct 13;10(10):e0140203. doi: 10.1371/journal.pone.0140203. eCollection 2015.
PubMed 26461064Jordan S, Banner T, Gabe-Walters M, Mikhail JM, Panes G, Round J, Snelgrove S, Storey M, Hughes D; Medicines' Management Group, Swansea University. Nurse-led medicines' monitoring in care homes, implementing the Adverse Drug Reaction (ADRe) Profile improvement initiative for mental health medicines: An observational and interview study. PLoS One. 2019 Sep 11;14(9):e0220885. doi: 10.1371/journal.pone.0220885. eCollection 2019.
PubMed 31509537Mangoni AA, Jackson SH. Age-related changes in pharmacokinetics and pharmacodynamics: basic principles and practical applications. Br J Clin Pharmacol. 2004 Jan;57(1):6-14. doi: 10.1046/j.1365-2125.2003.02007.x.
PubMed 14678335Masnoon N, Shakib S, Kalisch-Ellett L, Caughey GE. What is polypharmacy? A systematic review of definitions. BMC Geriatr. 2017 Oct 10;17(1):230. doi: 10.1186/s12877-017-0621-2.
PubMed 29017448NHS Digital (2017). Health Survey for England 2016: Prescribed medicines. https://files.digital.nhs.uk/pdf/3/c/hse2016-pres-med.pdf
NICE Medicines and Prescribing Centre. (2015). Medicines optimisation: the safe and effective use of medicines to enable the best possible outcomes. NICE Guideline 5. London: NICE
Sirois C, Domingues NS, Laroche ML, Zongo A, Lunghi C, Guenette L, Kroger E, Emond V. Polypharmacy Definitions for Multimorbid Older Adults Need Stronger Foundations to Guide Research, Clinical Practice and Public Health. Pharmacy (Basel). 2019 Aug 29;7(3):126. doi: 10.3390/pharmacy7030126.
PubMed 31470621Logan V, Conboy A, Carter N, Hughes D, Turner A, Watkins A, Jordan S. "A better system" - managing the adverse effects of prescribed medicines: Cluster-randomised controlled trial and process evaluation of the ADRe Profile in primary care. PLoS One. 2026 Sep 18;21(9):e0356480. doi: 10.1371/journal.pone.0356480. eCollection 2026.
PubMed 42758689Logan V, Hughes D, Turner A, Carter N, Jordan S. Breaking barriers: feasibility of a cluster randomised trial evaluating an instrument for identifying and ameliorating adverse drug reactions. BMJ Open. 2026 Jan 27;16(1):e099627. doi: 10.1136/bmjopen-2025-099627.
PubMed 41592836Logan V, Carter N, Hughes D, Turner A, Jordan S. Reducing Adverse Drug Reactions for Older People in the Community: Evaluating the Validity and Reliability of the ADRe Profile. J Nurs Manag. 2025 May 14;2025:9921349. doi: 10.1155/jonm/9921349. eCollection 2025.
PubMed 40401039
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication Monitoring in General Practice: Clinical Impact of Implementing a Nurse-led Adverse Drug Reaction (ADRe) Profile in Older Adults With 5 or More Prescribed Medicines
- ClinicalTrials.gov ID
- NCT04663360
- Acronym / sponsor ID
- Swansea Nursing
- Conditions
- Polypharmacy
- Keywords
- medicines management, adverse drug reaction, nurses, primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Swansea UniversityUniversity, hospital or other
- Collaborators
- Abertawe Bro Morgannwg University Health Board, Hywel Dda Health Board
- Study start
- 5 Jan 2020 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 4 Oct 2020 (actual)
- First posted
- 11 Dec 2020 (actual)
- 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.
Polypharmacy has the potential to harm older adults by causing cognitive impairment, falls, and hospitalisations. Many adverse drug reactions could be prevented with closer monitoring. This project will establish the effectiveness of the nurse-led intervention - the ADRe Profile - for medicines commonly prescribed in primary care and evaluate intervention implementation in general practices.
Detailed description
The number of medicines people take is increasing. Older adults are particularly at risk of adverse drug reactions due to polypharmacy. Adverse drug reactions cause avoidable patient harm, and around 5-8% of unplanned hospital admissions in the UK, costing the NHS £1.5-2.5bn pa. Many adverse drug reactions could be prevented with closer monitoring. The nurse-led Adverse Drug Reactions Profile (ADRe Profile) represents a unique instrument that records patients' observations and self-reported information on signs and symptoms that is likely to relate to an adverse reaction to medications. This project will establish the effectiveness of ADRe Profile in identifying patient problems possibly resulting from medicines in general practices and will be implemented in 3 phases.
Phase 1 (4 months) Validity and reliability testing of the ADRe Profile will be performed with key stakeholders (patients, nurses, care assistants, GP's and pharmacists), before introducing the tool to general practices. Feasibility testing will also be undertaken.
Phase 2 (12 months) The aim of this phase is to test whether the ADRe Profile identifies and ameliorates health problems. The practice nurse (or the researcher) will perform an ADRe consultation with a group of eligible service users and compare the number and nature of health and well-being problems identified with a similar group of service users who receive normal care.
Phase 3 (6 months) Finally, to further explore the impact of the ADRe Profile, the researchers will conduct semi-structured interviews with health professionals (nurses, care assistants, GPs and pharmacists) and service users.
The investigators hope that this study will help patients gain maximum benefits from their medicines and support nurses, pharmacists and GP's to reduce any bothersome side effects and problems that, if not addressed promptly, can lead to hospital admissions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participating GP practices will be randomised into an intervention and control arms.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Adverse Drug Reaction (ADRe) ProfileIntervention to be administered: Adverse Drug Reactions (ADRe) Profile. asks nurses to systematically check patients for the manifestation of itemised adverse side effects or undesirable effects of their primary care medicines, as listed in the BNF and manufacturers' Summaries of Product Characteristics (SmPCs), and seminal texts documenting known ADRs. Nurses are asked to share the identified problems with prescribers and pharmacists overseeing medicines charts. |
| Control | No intervention | –Usual clinical care. |
Who may qualify
- Ages
- 64 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age > 64 years
- with a long-term condition
- prescribed > 5 medications daily. (Vitamin and nutritional supplements and moisturising skin preparations will not be counted as 'medicines'.)
- Willing and able to give informed, signed consent themselves, or where capacity is lacking in the opinion of their nurses, a consultee/representative accompanying the patient who is willing to give advice and assent to the service user participating and sign on their behalf.
Key exclusion criteria (9 listed)
- Age < 64 years
- Without any long-term conditions
- Prescribed < 5 medications daily
- Not willing to participate
- Unable to consent and no consultee/representative present
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adverse Drug Reaction (ADRe) ProfileADRe asks nurses to systematically check patients for the manifestation of itemised adverse side effects or undesirable effects of their primary care medicines, as listed in the BNF and manufacturers' Summaries of Product Characteristics (SmPCs), and seminal texts documenting known ADRs. Nurses are asked to share the identified problems with prescribers and pharmacists overseeing medicines charts. | Other | Intervention |
Primary outcome
Level of completion of all items in the video call-completed ADRe Profile
Time frame: 4 months from the start of the study
Comparison of completeness of the ADRe Profile completed through a video call with ADRe Profiles previously completed in person
Inter-rater reliability of patient versus nurse (or nurse-researcher) completed ADRe Profile (Cohen's Kappa).
Time frame: 4 months from the start of the study
To determine how much of the potential variability of the records is due to errors in measurement, to estimate a degree to which service users accurately evaluate their symptoms when compared with a nurse researcher. Cohen's Kappa will be calculated.
Calculated percentage and described nature of items on the ADRe Profile that can be populated from accessing the nursing and medical notes.
Time frame: 16 months from the start of the study
Establishing the overlap of information - the number and nature of the ADRe items that have previously been collected and recorded in the patients' nursing and medical notes.
Clinical impact on service users, including new problems identified (number and nature) and problems addressed (number and nature)
Time frame: 16 months from the start of the study
Number of patients with a change in signs and symptoms related to adverse effects of prescribed medicines. Care quality/ clinical gain/ benefit to patients as recorded in notes and on the Profile by the number and nature of all health problems addressed, particularly serious adverse events.
Prescription changes
Time frame: 16 months from the start of the study
Number of patients with changes in prescription regimens: drug or dose. Number and nature of changes.
Description of stakeholder views on ADRe Profile implementation effectiveness (survey rating of the ADRe Profile - Likert scale)
Time frame: 22 months from the start of the study
A brief survey will be distributed to the main stakeholders (patients, nurses, GP's and pharmacists) following completion of Randomised Controlled Trial.
Description of stakeholder views on ADRe Profile implementation feasibility (eliciting interview themes)
Time frame: 22 months from the start of the study
Semi-structured interview with the main stakeholders (patients, nurses, GP's and pharmacists) to explore their views on feasibility of ADRe Profile integration in GP practices.
4 secondary outcomes
Calculation of the average nurses', GP's and pharmacists' length of time per one ADRe Profile completion
Time frame: 16 months from the start of the study
Calculation of the cost of nurses', GP's and pharmacists' time, based on average national salary cost per hour.
Time frame: 16 months from the start of the study
Description of the main stakeholders' views on multidisciplinary collaboration (eliciting interview themes)
Time frame: 22 months from the start of the study
Description of the patients' views on the contribution of ADRe Profile to patient-centered care (eliciting interview themes).
Time frame: 22 months from the start of the study
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 7 Oct 2021.
- Background: PubMed 24798210Gabe ME, Murphy F, Davies GA, Russell IT, Jordan S. Medication monitoring in a nurse-led respiratory outpatient clinic: pragmatic randomised trial of the West Wales Adverse Drug Reaction Profile. PLoS One. 2014 May 5;9(5):e96682. doi: 10.1371/journal.pone.0096682. eCollection 2014.
- Background: PubMed 27902153Jones R, Moyle C, Jordan S. Nurse-led medicines monitoring: a study examining the effects of the West Wales Adverse Drug Reaction Profile. Nurs Stand. 2016 Nov 30;31(14):42-53. doi: 10.7748/ns.2016.e10447.
- Background: PubMed 12028277Jordan S. Managing adverse drug reactions: an orphan task. J Adv Nurs. 2002 Jun;38(5):437-48. doi: 10.1046/j.1365-2648.2002.02205.x.
- Background: PubMed 11851783Jordan S, Tunnicliffe C, Sykes A. Minimizing side-effects: the clinical impact of nurse-administered 'side-effect' checklists. J Adv Nurs. 2002 Jan;37(2):155-65. doi: 10.1046/j.1365-2648.2002.02064.x.
- Background: PubMed 24707218Jordan S, Gabe M, Newson L, Snelgrove S, Panes G, Picek A, Russell IT, Dennis M. Medication monitoring for people with dementia in care homes: the feasibility and clinical impact of nurse-led monitoring. ScientificWorldJournal. 2014 Feb 23;2014:843621. doi: 10.1155/2014/843621. eCollection 2014.
- Background: PubMed 26461064Jordan S, Gabe-Walters ME, Watkins A, Humphreys I, Newson L, Snelgrove S, Dennis MS. Nurse-Led Medicines' Monitoring for Patients with Dementia in Care Homes: A Pragmatic Cohort Stepped Wedge Cluster Randomised Trial. PLoS One. 2015 Oct 13;10(10):e0140203. doi: 10.1371/journal.pone.0140203. eCollection 2015.
- Background: PubMed 31509537Jordan S, Banner T, Gabe-Walters M, Mikhail JM, Panes G, Round J, Snelgrove S, Storey M, Hughes D; Medicines' Management Group, Swansea University. Nurse-led medicines' monitoring in care homes, implementing the Adverse Drug Reaction (ADRe) Profile improvement initiative for mental health medicines: An observational and interview study. PLoS One. 2019 Sep 11;14(9):e0220885. doi: 10.1371/journal.pone.0220885. eCollection 2019.
- Background: PubMed 14678335Mangoni AA, Jackson SH. Age-related changes in pharmacokinetics and pharmacodynamics: basic principles and practical applications. Br J Clin Pharmacol. 2004 Jan;57(1):6-14. doi: 10.1046/j.1365-2125.2003.02007.x.
- Background: PubMed 29017448Masnoon N, Shakib S, Kalisch-Ellett L, Caughey GE. What is polypharmacy? A systematic review of definitions. BMC Geriatr. 2017 Oct 10;17(1):230. doi: 10.1186/s12877-017-0621-2.
- BackgroundNHS Digital (2017). Health Survey for England 2016: Prescribed medicines. https://files.digital.nhs.uk/pdf/3/c/hse2016-pres-med.pdf
- BackgroundNICE Medicines and Prescribing Centre. (2015). Medicines optimisation: the safe and effective use of medicines to enable the best possible outcomes. NICE Guideline 5. London: NICE
- Background: PubMed 31470621Sirois C, Domingues NS, Laroche ML, Zongo A, Lunghi C, Guenette L, Kroger E, Emond V. Polypharmacy Definitions for Multimorbid Older Adults Need Stronger Foundations to Guide Research, Clinical Practice and Public Health. Pharmacy (Basel). 2019 Aug 29;7(3):126. doi: 10.3390/pharmacy7030126.
- Individual participant dataSharing planned: No
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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.
Sue Jordan, PhD study chair
Swansea University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adverse Drug Reaction (ADRe) Profile in people with Polypharmacy, run by Swansea University at 1 site 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 5 inclusion and 9 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 7 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Level of completion of all items in the video call-completed ADRe Profile (time frame: 4 months from the start of the study). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04663360, which also lists 16 linked publications.
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 7 Oct 2021.