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(De)Prescribing in Hospitalized Sarcopenic Geriatric Patients

ConditionSarcopenia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age70+
SponsorZuyderland Medisch Centrum

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Being not instructible

Having an implantable cardioverter defibrillator (ICD)

No informed consent can be optained with the participant or a legal representative

Trial design

Design model

Parallel

Treatments tested in this trial

  • deprescribing pharmacotherapy approach (DPA)

    Other intervention

    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 intervention

    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.

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: deprescribing pharmacotherapy approach (DPA)Experimental treatment 1 intervention
Group B: STOPP-START deprescribing approach (SSA)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
6 months

Secondary outcomes

1

Adverse Drug Reactions (ADR)

Number and severity of adverse drug reactions (ADR)

Time frame
6 months
2

Complications due to medication

Number and severity of complications due to medication

Time frame
6 months
3

Hospital readmission

Hospital readmission during follow up

Time frame
6 months
4

The quality of life

Quality of life, obtained through questionnaires

Time frame
6 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zuyderland Medisch Centrum

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: