SarcopeniaMEDEGESARCNCT05757765
(De)Prescribing in Hospitalized Sarcopenic Geriatric Patients
A study testing deprescribing pharmacotherapy approach (DPA) and STOPP-START deprescribing approach (SSA) in people with Sarcopenia, run by Zuyderland Medisch Centrum.
Trial summary
The goal of this clinical trial is to compare the effects of a deprescribing pharmacotherapy approach to the STOPP-START approach (usual care) in geriatric patients with sarcopenia and polypharmacy. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Sarcopenia
- What is being tested?
- deprescribing pharmacotherapy approach (DPA) and STOPP-START deprescribing approach (SSA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 27 Feb 2023to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged 70 years and older
- Being frail according the Groningen Frailty Indicator (GFI score >3)
- Severely sarcopenic according the European Working Group On Sarcopenia-2 criteria (EWGSOP-2) based on handgrip strength (men < 27kg and women < 16kg), appendicular skeletal muscle mass (men < 7,0 kg/m2 and women < 5,5 kg/m2) and physical function below cut-off values (Short Physical Performance Battery <9)
- The use of 5 or more different medications before hospitalization
Who cannot join
- Being not instructible
- Having an implantable cardioverter defibrillator (ICD)
- No informed consent can be optained with the participant or a legal representative
About this study
Official title: Medication (de)Prescribing in Hospitalized Geriatric Patients With Sarcopenia, Less is More
The goal of this clinical trial is to compare the effects of a deprescribing pharmacotherapy approach to the STOPP-START approach (usual care) in geriatric patients with sarcopenia and polypharmacy. The main question it aims to answer is the number and type of medication that can be stopped in this population without being restarted within 6 months.
After inclusion a medication review is performed by a team consisting of the researcher, a geriatrician and a hospital pharmacist, according to the protocol within which the patient was randomised. Participants are follow up at appointments after 1, 3 and 6 months. At these appointments, questionnaires are administered about the quality of life and complications related to medication.
Read the detailed description
Rationale Acutely ill hospitalized geriatric patients have co-morbid disease and polypharmacy and 2/3 have low muscle strength and low muscle mass, called sarcopenic. Although all efforts are done by the multidisciplinary team to combat health problems and negative sequalae of sarcopenia, 80% of the (severely) sarcopenic patients will be deceased within 2 years. Optimalization medication is part of this multidisciplinary treatment strategy. The STOPP START criteria are applied to optimize the polypharmacy. However, it is not known whether this strategy actually results in a better or worse outcome for these patients. The question that arises is whether it is even better to minimize pharmacotherapy in these patients and only apply it if the aim is to combat symptoms and complaints and to stop (preventive) medication as much as possible. The latter is called a deprescribing pharmacotherapy approach (DPA) and seemed to be successful in a previous study concerning older frail patients.
Objective:
The effects of DPA compared to STOPP-START approach (SSA) prescribing on adverse drug reactions, medical complications, hospital readmission, quality of life in hospitalized geriatric patients with sarcopenia
Study design:
Prospective randomised intervention study. Patients will be randomised in two groups: intervention group (IG) with a DPA of 80 patients and an control group (CG) of 80 patients with a SSA.
Study population:
Acutely ill geriatric patients with sarcopenia and polypharmacy admitted to the acute care geriatric ward of Zuyderland Medical Centre.
Intervention:
Medication review in patients randomised to the IG group will be performed according to the principles of DPA and in the CG this will be performed following the SSA approach.
Main study parameters/endpoints:
Primary endpoint: the number and type of medication stopped and not restarted during medication review and number and type of medication restarted within 1, 3 and 6 months. Secondary endpoints: number and severity of Adverse Drug Reactions (ADR) and complications due to medication (e.g. delirium or falls), hospital readmission, quality of life (QoL) and mortality
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
In either of the two strategies of reviewing medication (SSA or DPA) there are risks for the sarcopenic patients with polypharmacy as part of the usual care. Applying the SSA, which is actually the usual care in the Dutch geriatric ward, there is serious risk of overtreatment with a risk of ADR and complications with holding off benefit because of a necessary time until benefit compared to the limited life expectancy. Although the risk for a ADR is low, a ADR with different kinds of impact can be expected however when starting e.g. preventive medication. But withholding preventative medication as part of DPA can cause a new health problem with minor to major impact if the life expectancy seems longer than predicted and exceeds the time until benefit. Overall, the aim of DPA is to optimize pharmacotherapy and reduce ADR, medication related complications and improve quality of life.
- Conditions
- Sarcopenia
- Being tested
- deprescribing pharmacotherapy approach (DPA), STOPP-START deprescribing approach (SSA)
- Keywords
- Polypharmacy, Deprescribing, Geriatric patients
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deprescribing pharmacotherapy approach (DPA)Other
A new way of medication review in patients with sarcopenia. This method is based on previous scientific research and is aimed at minimizing pharmacotherapy. The aim is to combat symptoms and complaints and to stop (preventive) medication as much as possible
STOPP-START deprescribing approach (SSA)Other
The usual care in the geriatric medicine in the Netherlands consisting of a medication review based on the STOPP-START criteria. These criteria have been combined in a protocol that describes when certain medication(groups) must be continued or discontinued for specific patient characteristics.
| Study group | Role | What they receive |
|---|---|---|
| deprescribing pharmacotherapy approach (DPA) | Experimental | A new way of medication review in patients with sarcopenia. This method is based on previous scientific research and is aimed at minimizing pharmacotherapy. The aim is to combat symptoms and complaints and to stop (preventive) medication as much as possible Receives: Other: deprescribing pharmacotherapy approach (DPA) |
| STOPP-START deprescribing approach (SSA) | Active comparator | The usual care in the geriatric medicine in the Netherlands consisting of a medication review based on the STOPP-START criteria. These criteria have been combined in a protocol that describes when certain medication(groups) must be continued or discontinued for specific patient characteristics. Receives: Other: STOPP-START deprescribing approach (SSA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deprescribing
The number and type of medication stopped and not restarted during medication review and number and type of medication restarted within 1, 3 and 6 months
Measured: 6 months
Secondary outcomes (5)
Adverse Drug Reactions (ADR)
Number and severity of adverse drug reactions (ADR)
Measured: 6 months
Complications due to medication
Number and severity of complications due to medication
Measured: 6 months
Hospital readmission
Hospital readmission during follow up
Measured: 6 months
The quality of life
Quality of life, obtained through questionnaires
Measured: 6 months
Mortality
Mortality during follow up
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 posted7 Mar 2023
- Study start27 Feb 2023 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies 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
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zuyderland Medisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05757765
- Sponsor's protocol ID
- ZuyderlandMC
- Acronym
- MEDEGESARC
- Status last verified
- Feb 2023
- First submitted
- 23 Feb 2023
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication (de)Prescribing in Hospitalized Geriatric Patients With Sarcopenia, Less is More
- ClinicalTrials.gov ID
- NCT05757765
- Acronym / sponsor ID
- MEDEGESARC / ZuyderlandMC
- Conditions
- Sarcopenia
- Keywords
- Polypharmacy, Deprescribing, Geriatric patients
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Zuyderland Medisch CentrumUniversity, hospital or other
- Study start
- 27 Feb 2023 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 7 Mar 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.
The goal of this clinical trial is to compare the effects of a deprescribing pharmacotherapy approach to the STOPP-START approach (usual care) in geriatric patients with sarcopenia and polypharmacy. The main question it aims to answer is the number and type of medication that can be stopped in this population without being restarted within 6 months.
After inclusion a medication review is performed by a team consisting of the researcher, a geriatrician and a hospital pharmacist, according to the protocol within which the patient was randomised. Participants are follow up at appointments after 1, 3 and 6 months. At these appointments, questionnaires are administered about the quality of life and complications related to medication.
Detailed description
Rationale Acutely ill hospitalized geriatric patients have co-morbid disease and polypharmacy and 2/3 have low muscle strength and low muscle mass, called sarcopenic. Although all efforts are done by the multidisciplinary team to combat health problems and negative sequalae of sarcopenia, 80% of the (severely) sarcopenic patients will be deceased within 2 years. Optimalization medication is part of this multidisciplinary treatment strategy. The STOPP START criteria are applied to optimize the polypharmacy. However, it is not known whether this strategy actually results in a better or worse outcome for these patients. The question that arises is whether it is even better to minimize pharmacotherapy in these patients and only apply it if the aim is to combat symptoms and complaints and to stop (preventive) medication as much as possible. The latter is called a deprescribing pharmacotherapy approach (DPA) and seemed to be successful in a previous study concerning older frail patients.
Objective:
The effects of DPA compared to STOPP-START approach (SSA) prescribing on adverse drug reactions, medical complications, hospital readmission, quality of life in hospitalized geriatric patients with sarcopenia
Study design:
Prospective randomised intervention study. Patients will be randomised in two groups: intervention group (IG) with a DPA of 80 patients and an control group (CG) of 80 patients with a SSA.
Study population:
Acutely ill geriatric patients with sarcopenia and polypharmacy admitted to the acute care geriatric ward of Zuyderland Medical Centre.
Intervention:
Medication review in patients randomised to the IG group will be performed according to the principles of DPA and in the CG this will be performed following the SSA approach.
Main study parameters/endpoints:
Primary endpoint: the number and type of medication stopped and not restarted during medication review and number and type of medication restarted within 1, 3 and 6 months. Secondary endpoints: number and severity of Adverse Drug Reactions (ADR) and complications due to medication (e.g. delirium or falls), hospital readmission, quality of life (QoL) and mortality
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
In either of the two strategies of reviewing medication (SSA or DPA) there are risks for the sarcopenic patients with polypharmacy as part of the usual care. Applying the SSA, which is actually the usual care in the Dutch geriatric ward, there is serious risk of overtreatment with a risk of ADR and complications with holding off benefit because of a necessary time until benefit compared to the limited life expectancy. Although the risk for a ADR is low, a ADR with different kinds of impact can be expected however when starting e.g. preventive medication. But withholding preventative medication as part of DPA can cause a new health problem with minor to major impact if the life expectancy seems longer than predicted and exceeds the time until benefit. Overall, the aim of DPA is to optimize pharmacotherapy and reduce ADR, medication related complications and improve quality of life.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| deprescribing pharmacotherapy approach (DPA) | Experimental | Other: deprescribing pharmacotherapy approach (DPA)A new way of medication review in patients with sarcopenia. This method is based on previous scientific research and is aimed at minimizing pharmacotherapy. The aim is to combat symptoms and complaints and to stop (preventive) medication as much as possible |
| STOPP-START deprescribing approach (SSA) | Active comparator | Other: STOPP-START deprescribing approach (SSA)The usual care in the geriatric medicine in the Netherlands consisting of a medication review based on the STOPP-START criteria. These criteria have been combined in a protocol that describes when certain medication(groups) must be continued or discontinued for specific patient characteristics. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Aged 70 years and older
- Being frail according the Groningen Frailty Indicator (GFI score >3)
- Severely sarcopenic according the European Working Group On Sarcopenia-2 criteria (EWGSOP-2) based on handgrip strength (men < 27kg and women < 16kg), appendicular skeletal muscle mass (men < 7,0 kg/m2 and women < 5,5 kg/m2) and physical function below cut-off values (Short Physical Performance Battery <9)
- The use of 5 or more different medications before hospitalization
Key exclusion criteria (3 listed)
- Being not instructible
- Having an implantable cardioverter defibrillator (ICD)
- No informed consent can be optained with the participant or a legal representative
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 |
|---|---|---|
| deprescribing pharmacotherapy approach (DPA)A new way of medication review in patients with sarcopenia. This method is based on previous scientific research and is aimed at minimizing pharmacotherapy. The aim is to combat symptoms and complaints and to stop (preventive) medication as much as possible | Other | deprescribing pharmacotherapy approach (DPA) |
| STOPP-START deprescribing approach (SSA)The usual care in the geriatric medicine in the Netherlands consisting of a medication review based on the STOPP-START criteria. These criteria have been combined in a protocol that describes when certain medication(groups) must be continued or discontinued for specific patient characteristics. | Other | STOPP-START deprescribing approach (SSA) |
Primary outcome
Deprescribing
Time frame: 6 months
The number and type of medication stopped and not restarted during medication review and number and type of medication restarted within 1, 3 and 6 months
5 secondary outcomes
Adverse Drug Reactions (ADR)
Time frame: 6 months
Complications due to medication
Time frame: 6 months
Hospital readmission
Time frame: 6 months
The quality of life
Time frame: 6 months
Mortality
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing deprescribing pharmacotherapy approach (DPA) and STOPP-START deprescribing approach (SSA) in people with Sarcopenia, run by Zuyderland Medisch Centrum.
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 4 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: opening soon, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Deprescribing (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 7 Mar 2023.