PolypharmacyNCT05501223
Physician-initiated Medication Review in a Type 2 Diabetes Outpatient Clinic
A study testing Medication review in people with Polypharmacy, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
Aiming to reduce polypharmacy in patients with type 2 diabetes by using physician-initiated medication reviews. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Polypharmacy
- What is being tested?
- Medication review
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2020to Nov 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- DM2
- 12 medications in the central prescription list
Who cannot join
- inability to give written consent (e.g., inability to understand the intervention or language barriers);
- active cancer or palliative treatment;
- admitted to the hospital.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Bispebjerg Hospital
Copenhagen
Karl Sebastian Johansson, MD, +4538635604, karl.sebastian.johansson@regionh.dk
About this study
Aiming to reduce polypharmacy in patients with type 2 diabetes by using physician-initiated medication reviews.
Read the detailed description
Patients will be randomised to either standard care(annual visit at outpatient clinic) or standard care plus an intervention. The intervention is a medication consultation of 30-60 minutes that consist of a medication review and increased cross-sectoral communication. Follow-up is 6 months. Primary outcome are number of medications used, secondary outcomes are health related quality of life and persistance of medication changes.
- Conditions
- Polypharmacy
- Being tested
- Medication review, Standard care
- Keywords
- Polypharmacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication reviewOther
30-60 minutes extra consultation regarding the patients drugs
Standard careOther
Standard care i.e. visit at the Dept. of Endocrinology.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Standard care + medication review Receives: Other: Medication review; Other: Standard care |
| Control | Other | Standard care Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of medications used at baseline compared to number of medications used at follow-up. Resulting in a rate of medications used at baseline compared to follow-up i.e. no. medication at follow-up/no. at baseline.
The no. of medications used at baseline will be compared to the no. of medications used at follow-up. This will result in a rate i.e. no. at follow-up/no. at baseline which can be compared between groups resulting in a rate ratio. Medication usage is determined by number of medications listed in the central prescription list.
Measured: 6 months
Secondary outcomes (1)
EQ5D index score. (a Euro Quality of Life 5-dimension 5-level (EQ-5D-5L) scale). The score is retrieved by using the validated EQ5D questionnaire which translates to a corresponding EQ5D index score using country specific value sets.
Health related quality of life measured by EQ5D index score using Danish value sets (ranging from -0.7 (worst quality of life) to 1 (best quality of life)).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start1 Nov 2020
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karl Sebastian Johansson, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05501223
- Sponsor's protocol ID
- P-2020-1012
- Status last verified
- Aug 2022
- First submitted
- 3 Aug 2021
- Last updated
- 15 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physician-initiated Medication Review in a Type 2 Diabetes Outpatient Clinic
- ClinicalTrials.gov ID
- NCT05501223
- Acronym / sponsor ID
- P-2020-1012
- Conditions
- Polypharmacy
- Keywords
- Polypharmacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 15 Aug 2022 (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.
Aiming to reduce polypharmacy in patients with type 2 diabetes by using physician-initiated medication reviews.
Detailed description
Patients will be randomised to either standard care(annual visit at outpatient clinic) or standard care plus an intervention. The intervention is a medication consultation of 30-60 minutes that consist of a medication review and increased cross-sectoral communication. Follow-up is 6 months. Primary outcome are number of medications used, secondary outcomes are health related quality of life and persistance of medication changes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Other: Medication review, Other: Standard careStandard care + medication review |
| Control | Other | Other: Standard careStandard care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- DM2
- 12 medications in the central prescription list
Key exclusion criteria (3 listed)
- inability to give written consent (e.g., inability to understand the intervention or language barriers);
- active cancer or palliative treatment;
- admitted to the hospital.
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 |
|---|---|---|
| Medication review30-60 minutes extra consultation regarding the patients drugs | Other | Intervention |
| Standard careStandard care i.e. visit at the Dept. of Endocrinology. | Other | Control, Intervention |
Primary outcome
Number of medications used at baseline compared to number of medications used at follow-up. Resulting in a rate of medications used at baseline compared to follow-up i.e. no. medication at follow-up/no. at baseline.
Time frame: 6 months
The no. of medications used at baseline will be compared to the no. of medications used at follow-up. This will result in a rate i.e. no. at follow-up/no. at baseline which can be compared between groups resulting in a rate ratio. Medication usage is determined by number of medications listed in the central prescription list.
1 secondary outcome
EQ5D index score. (a Euro Quality of Life 5-dimension 5-level (EQ-5D-5L) scale). The score is retrieved by using the validated EQ5D questionnaire which translates to a corresponding EQ5D index score using country specific value sets.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medication review in people with Polypharmacy, run by Bispebjerg Hospital at 1 site in Denmark.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 15 Aug 2022. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of medications used at baseline compared to number of medications used at follow-up. Resulting in a rate of medications used at baseline compared to follow-up i.e. no. medication at follow-up/no. at baseline. (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 15 Aug 2022.