(De)Prescribing in Hospitalized Sarcopenic Geriatric Patients

NCT05757765 | Not Yet Recruiting DMC

• 1 other identifier: ZuyderlandMC
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Sarcopenia

Keywords

Polypharmacy; Deprescribing; Geriatric patients

Outcome Measures

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

  6 months

Secondary Outcomes (5)

• Adverse Drug Reactions (ADR)

  6 months

• Complications due to medication

  6 months

• Hospital readmission

  6 months

• The quality of life

  6 months

• Mortality

  6 months

Study Arms (2)

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

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.

Other: STOPP-START deprescribing approach (SSA)

Interventions

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

deprescribing pharmacotherapy approach (DPA)

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.

STOPP-START deprescribing approach (SSA)

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Being not instructible
• Having an implantable cardioverter defibrillator (ICD)
• No informed consent can be optained with the participant or a legal representative

Sponsors & Collaborators

• Zuyderland Medisch Centrum: lead

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 7, 2023
• Study Start: February 27, 2023
• Primary Completion: February 1, 2025
• Study Completion (Estimated): August 1, 2027
• Last Updated: March 7, 2023

Record last verified: 2023-02