Chronic DiseaseNCT05721534
Deprescribing and Health-related Effects
An observational study of Chronic Disease, run by Anne Estrup Olesen at 1 site in Denmark.
Trial summary
In a primary care settled quality improvement project aiming to deprescribe medication through a medication review intervention, we investigated how the implemented medication changes affected health-related outcomes in real-life patients. Read more about this study
- Who is it for?
- Ages 50 to 105 years
- Conditions the study is for
- Chronic Disease
- What is being tested?
- Medication review
- How many people
- 87 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2020to 31 Dec 2022
- How long will I take part?
- 4 Months
- 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 50 to 105 years
- All sexes
- Adult, Older adult
Study population: The study included care home residents living in selected care homes, in which the GPF was associated "care home doctors", and community-dwelling patients with chronic disease listed with the GPF.
Who may be able to join
- new residents and residents that had not yet attended a consultation focusing on pharmacological treatment in The Chronic Care Model.
- patients were invited for the consultation focusing on pharmacological treatment in the month of their birthday and, thereby, included randomly and consecutively throughout the study period.
Who cannot join
- unable to collaborate on follow-up questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effective Deprescribing in Primary Care Without Deterioration of Health-related Outcomes
In a primary care settled quality improvement project aiming to deprescribe medication through a medication review intervention, we investigated how the implemented medication changes affected health-related outcomes in real-life patients.
Read the detailed description
The project was approved by the Management in the Municipality of Frederikshavn. According to Danish legislation, no formal permission from the national or regional Committee on Health Research Ethics was required for this type of study, as patients were not treated inferior to usual care and no biological material was collected. It was conducted as a quality improvement project and informed consent was not required for the specific data collected. The study is in compliance with the General Data Protection Regulation and a part of North Denmark Region's record of processing activities (K2023-008).
- Conditions
- Chronic Disease
- Being tested
- Medication review
- Keywords
- Primary care, Medication review, Deprescribing, Polypharmacy, Chronic disease management
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication reviewOther
Also called Medication review with focus on deprescribing
Annual consultation focusing on pharmacological treatment. This specific consultation constituted the "intervention". It included a structured review of the patient's health state, in addition to a structured medication review with a focus on appropriate medication and deprescribing.
| Study group | Role | What they receive |
|---|---|---|
| Care home residents | The intervention was offered to new residents and residents that had not yet attended a consultation focusing on pharmacological treatment in The Chronic Care Model. Receives: Other: Medication review | |
| Community-dwelling patients with chronic disease | Patients were invited for the consultation focusing on pharmacological treatment in the month of their birthday and, thereby, included randomly and consecutively throughout the study period. Receives: Other: Medication review |
What is being measured
The primary outcome is the main question the study is designed to answer.
self-reported health status
(on a scale from 1 to 10)
Measured: 4 months
Secondary outcomes (2)
general condition
(rated on a 5-point Likert Scale)
Measured: 4 months
functional level
rated on a 5-point Likert Scale
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start1 Jan 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 87 participants (actual)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Anne Estrup Olesen
- Sponsor type
- University, hospital or other
- Collaborators
- Frederikshavn Kommune, Frederikshavn, Denmark, Lægeklinikken Frederikshavn, Frederikshavn, Denmark
- Responsible party
- Sponsor-investigator, Anne Estrup Olesen, Aalborg University Hospital
- Investigators
- Anne E Olesen, Study chair, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05721534
- Sponsor's protocol ID
- K2023-008
- Status last verified
- Feb 2023
- First submitted
- 1 Feb 2023
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective Deprescribing in Primary Care Without Deterioration of Health-related Outcomes
- ClinicalTrials.gov ID
- NCT05721534
- Acronym / sponsor ID
- K2023-008
- Conditions
- Chronic Disease
- Keywords
- Primary care, Medication review, Deprescribing, Polypharmacy, Chronic disease management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Anne Estrup OlesenUniversity, hospital or other
- Collaborators
- Frederikshavn Kommune, Frederikshavn, Denmark, Lægeklinikken Frederikshavn, Frederikshavn, Denmark
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 10 Feb 2023 (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.
In a primary care settled quality improvement project aiming to deprescribe medication through a medication review intervention, we investigated how the implemented medication changes affected health-related outcomes in real-life patients.
Detailed description
The project was approved by the Management in the Municipality of Frederikshavn. According to Danish legislation, no formal permission from the national or regional Committee on Health Research Ethics was required for this type of study, as patients were not treated inferior to usual care and no biological material was collected. It was conducted as a quality improvement project and informed consent was not required for the specific data collected. The study is in compliance with the General Data Protection Regulation and a part of North Denmark Region's record of processing activities (K2023-008).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 4 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Care home residents | – | Other: Medication reviewThe intervention was offered to new residents and residents that had not yet attended a consultation focusing on pharmacological treatment in The Chronic Care Model. |
| Community-dwelling patients with chronic disease | – | Other: Medication reviewPatients were invited for the consultation focusing on pharmacological treatment in the month of their birthday and, thereby, included randomly and consecutively throughout the study period. |
Who may qualify
- Ages
- 50 to 105 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study included care home residents living in selected care homes, in which the GPF was associated "care home doctors", and community-dwelling patients with chronic disease listed with the GPF.
Key inclusion criteria (2 listed)
- new residents and residents that had not yet attended a consultation focusing on pharmacological treatment in The Chronic Care Model.
- patients were invited for the consultation focusing on pharmacological treatment in the month of their birthday and, thereby, included randomly and consecutively throughout the study period.
Key exclusion criteria (1 listed)
- unable to collaborate on follow-up questionnaires
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 reviewAlso: Medication review with focus on deprescribingAnnual consultation focusing on pharmacological treatment. This specific consultation constituted the "intervention". It included a structured review of the patient's health state, in addition to a structured medication review with a focus on appropriate medication and deprescribing. | Other | Care home residents, Community-dwelling patients with chronic disease |
Primary outcome
self-reported health status
Time frame: 4 months
(on a scale from 1 to 10)
2 secondary outcomes
general condition
Time frame: 4 months
functional level
Time frame: 4 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 10 Feb 2023.
- 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.
Anne E Olesen study chair
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Disease, run by Anne Estrup Olesen 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 1 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 10 Feb 2023. 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?
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?
self-reported health status (time frame: 4 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 10 Feb 2023.