Self AdministrationAUTOGESTMEDNCT06639113
From Administration of Oral Medicines by Nurses to Controlled Self-administration: Impact on Safety of Administration During Hospitalisation
A study testing Self-administration medicines in people with Self Administration, run by Centre Hospitalier de Valenciennes at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Self Administration
- What is being tested?
- Self-administration medicines
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteFrance
- Study dates
- 24 May 2024to Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- Age < 18 years old
- Patients with poor compliance
- No chronic treatment
- Unstable disease
- Major cognitive, memory or depressive disorders
- Swallowing disorders
Show all 10Show fewer
- Prehension problems
- Patient under legal protection
- Patient under guardianship or curatorship
- Patient included in another trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CH Valenciennes
Valenciennes, 59300
Hanane FODIL, 0327140665, fodil-h@ch-valenciennes.fr
Quentin HIVER
About this study
Official title: Evaluation of the Safety of a Change of Practice in the Administration of Oral Medication During Hospitalisation: From Administration by the Nurse to Supervision of Self-administration of Medication in the Locomotor and Polyvalent Rehabilitation Department of the Valenciennes Hospital Centre.
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
- Being tested
- Self-administration medicines
- Keywords
- Rehabilitation, Self-management of medication, Administration, Autonomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-administration medicinesBehavioural
Management of drugs' administration by the patient
| Study group | Role | What they receive |
|---|---|---|
| Self administration of medication by the patient | Experimental | Self administration of medication by the patient Receives: Behavioral: Self-administration medicines |
| Administration of medication by the nurses | No intervention | Administration of medication by the nurses during medication administration rounds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of oral medication administration errors in self-administered patients
Total number of oral medication administration errors in self-administered patients
Measured: After 7 days of self-administration
Total number of oral medication administration errors in patients receiving administration by nurses
Total number of oral medication administration errors in patients receiving administration by nurses
Measured: After 7 days of administration by nurses
Secondary outcomes (4)
Medication compliance in self-managed patients
Medication compliance is assessed using the questionnaire "Evaluation of medication compliance" provided by the French health insurance system.
This questionnaire consists of 6 questions with "yes" or "no" answers. Each "no" answer is worth 1 point, each "yes" answer is worth 0 points. A patient with poor medication compliance will have a score of 3 or less.
Measured: At the beginning of the study
Medication compliance in self-managed patients
Medication compliance is assessed using the questionnaire "Evaluation of medication compliance" provided by the French health insurance system.
This questionnaire consists of 6 questions with "yes" or "no" answers. Each "no" answer is worth 1 point, each "yes" answer is worth 0 points. A patient with poor medication compliance will have a score of 3 or less.
Measured: 15 days after hospital discharge for self-managed patients
Patient satisfaction with self-administration of oral medication
Patient satisfaction was assessed using a questionnaire designed by the investigator, consisting of 9 questions giving a total of 45 points.
The higher the total, the higher the level of satisfaction.
Measured: Within 24 hours of discharge from hospital
Care staff satisfaction with self-administration
Care staff satisfaction was assessed using a questionnaire designed by the investigator, consisting of 4 questions totalling 20 points.
The higher the total, the higher the level of satisfaction.
Measured: 6 months after the beginning of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start24 May 2024
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self AdministrationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Valenciennes
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Quentin HIVER, PH, Principal investigator, Centre Hospitalier de Valenciennes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06639113
- Sponsor's protocol ID
- 2023-02-04
- Acronym
- AUTOGESTMED
- Status last verified
- Oct 2026
- First submitted
- 5 Sep 2024
- Last updated
- 20 Oct 2026
- 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 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety of a Change of Practice in the Administration of Oral Medication During Hospitalisation: From Administration by the Nurse to Supervision of Self-administration of Medication in the Locomotor and Polyvalent Rehabilitation Department of the Valenciennes Hospital Centre.
- ClinicalTrials.gov ID
- NCT06639113
- Acronym / sponsor ID
- AUTOGESTMED / 2023-02-04
- Conditions
- Self Administration
- Keywords
- Rehabilitation, Self-management of medication, Administration, Autonomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Centre Hospitalier de ValenciennesResearch network
- Study start
- 24 May 2024 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 15 Oct 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self administration of medication by the patient | Experimental | Behavioral: Self-administration medicinesSelf administration of medication by the patient |
| Administration of medication by the nurses | No intervention | –Administration of medication by the nurses during medication administration rounds |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (10 listed)
- Age < 18 years old
- Patients with poor compliance
- No chronic treatment
- Unstable disease
- Major cognitive, memory or depressive disorders
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 |
|---|---|---|
| Self-administration medicinesManagement of drugs' administration by the patient | Behavioural | Self administration of medication by the patient |
Primary outcome
Total number of oral medication administration errors in self-administered patients
Time frame: After 7 days of self-administration
Total number of oral medication administration errors in self-administered patients
Total number of oral medication administration errors in patients receiving administration by nurses
Time frame: After 7 days of administration by nurses
Total number of oral medication administration errors in patients receiving administration by nurses
4 secondary outcomes
Medication compliance in self-managed patients
Time frame: At the beginning of the study
Medication compliance in self-managed patients
Time frame: 15 days after hospital discharge for self-managed patients
Patient satisfaction with self-administration of oral medication
Time frame: Within 24 hours of discharge from hospital
Care staff satisfaction with self-administration
Time frame: 6 months after the beginning of the study
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 20 Oct 2026.
- 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.
Quentin HIVER, PH principal investigator
Centre Hospitalier de Valenciennes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-administration medicines in people with Self Administration, run by Centre Hospitalier de Valenciennes at 1 site in France.
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 10 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: looking for participants now, as of the sponsor's last update on 20 Oct 2026. 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 France. 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?
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?
Contact Quentin HIVER (0327143333, hiver-q@ch-valenciennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of oral medication administration errors in self-administered patients (time frame: After 7 days of self-administration). The study lists 2 primary outcomes in all. 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 20 Oct 2026.