From Administration of Oral Medicines by Nurses to Controlled Self-administration: Impact on Safety of Administration During Hospitalisation

NCT ID: NCT06639113

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-24
• Study Completion Date: 2026-05-31

Brief Summary

Medication administration practices during patient hospital stay tend to improve patient autonomy. Several studies have concluded that self-administration of medication programs in hospital centers have a beneficial effect on patients' knowledge of their medications, their compliance and the safety of administration. Nevertheless, few studies have been carried out in France on this subject. The aim of this study is to evaluate the impact of the change of nurses administration practices from the administration of each drugs to supervision of self-administration by the patient under a self-administration program.

Conditions

Self Administration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Self administration of medication by the patient

Self administration of medication by the patient

Group Type: EXPERIMENTAL

Self-administration medicines

Intervention Type: BEHAVIORAL

Management of drugs' administration by the patient

Administration of medication by the nurses

Administration of medication by the nurses during medication administration rounds

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Self-administration medicines

Management of drugs' administration by the patient

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Care in the rehabilitation unit of Hospital in Valenciennes, France
• Patient with a planned stay of 7 days or more
• Patient on chronic treatment before admission to hospital ;
• Patients taking their treatment alone at home;

Exclusion Criteria

• Age < 18 years old
• Patients with poor compliance
• No chronic treatment
• Unstable disease
• Major cognitive, memory or depressive disorders
• Swallowing disorders
• Prehension problems
• Patient under legal protection
• Patient under guardianship or curatorship
• Patient included in another trial

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier de Valenciennes

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Quentin HIVER, PH

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier de Valenciennes

Locations

CH Valenciennes

Valenciennes, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Quentin HIVER

Role: CONTACT

hiver-q@ch-valenciennes.fr

0327143333

Facility Contacts

Hanane FODIL

Role: primary

fodil-h@ch-valenciennes.fr

0327140665

Other Identifiers

2023-02-04

Identifier Type: -

Identifier Source: org_study_id