Clinical trial NCT06016101: Usefulness of the Medissimo Nurse Application for Supporting Medication Compliance in Elderly People With Chronic Polypathologies
Official title: Usefulness of the Medissimo Nurse Application for Supporting Medication Compliance in Elderly People With Chronic Polypathologies
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Digital Application
Elderly Person
Chronic Disease
Polypathology
Medication Compliance
Keywords: Compliance
medication adherence
electronic tool
digital health
e-health
user's experience
elderly
Lead sponsor: RIVAGES
Sponsor class: OTHER
First posted: 2023-08-29
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medissimo will contact 100 pharmacies that use the Medipac® system to ask them to take part in the study. The pharmacists to whom the study will be proposed will be selected from users in the Paris region for reasons of geographical proximity.

Patients will be selected from among Medipac® pillbox users dispensed by pharmacists who agree to take part in the study. All patients of pharmacists who accept and receive home visits by private nurses (beneficiaries of the Medissimo nurse application) will be considered eligible. We expect to include 5 patients per pharmacist (i.e. a total of 100 patients). As far as the patients are concerned, their nurse will have to be informed of the study, will give them the information letter and will have to ensure that they do not object to taking part.

The professionals (nurses, GPs and pharmacists) will be selected from Medissimo and chosen at random. The study investigator will contact them to offer to participate and to seek their consent.

Brief summary: In this study, the investigators are interested in the Medissimo nurse application, which is a medication monitoring application for the elderly dedicated to self-employed nurses. The aim is to estimate the consistency of the measure of medication compliance assessed by this application with reference measures, as well as the user experience of healthcare professionals with this application.

Detailed description: Introduction :

As people age, the number of chronic illnesses in the same person tends to increase. Poor compliance with treatment or interrupted medication exposes patients to risks to their health, and the consequences represent avoidable costs for the healthcare system. In practice, however, it is not easy to measure compliance with medication. E-health devices dedicated to taking medication represent a new way of measuring medication adherence, a necessary step towards improving it.

Objectives :

Main: To assess the concordance of adherence measurement by the Medissimo nurse application used in an existing e-Health device aimed at improving the dispensing and monitoring of prescribed medication for people living at home, with reference measurements.Secondary: To explore the user-experience of the healthcare professionals (pharmacists, nurses and GPs) involved with two aspects: use of the application itself and interest in the reports generated by this application.

Methods :

Methodological design: Cross-sectional observational study in routine care (RIPH3).

Patients: The study will focus on one hundred patients aged over 65, who are already Medipac® pillbox users and receive home nursing visits as part of their usual care. Each month, the beneficiaries of the service receive weekly pillboxes prepared by the referring pharmacist, and the homecare nurses are equipped with the Medissimo nurse smartphone application, which can be used to record the quality of doses taken, any undesirable effects, reasons for not taking the medication and dose adjustments. The system generates a monthly report summarising this monitoring, which is shared with the referring pharmacist and sent to the GP. In this way, the system produces a measure of medication compliance. To validate this measure, the investigators will carry out two reference measures of compliance with medication for the same patients: the Morisky questionnaire (completed by the home care nurse during a regular visit) and the pill count by the referring pharmacist when the pillboxes are renewed. The analysis will focus on the concordance between overall medication compliance measured by the Medissimo nurse application and that given by reference measurements.

Healthcare professionals: The study will also involve 60 healthcare professionals (20 nurses, 20 pharmacists, 20 GPs) affected by the application, in order to assess their user experience. For nurses' use of the application, the investigators will use the System Usability Scale (SUS) questionnaire in a telephone interview. To assess interest in the monthly reports sent to these professionals, the investigators will use a Likert-type questionnaire in a telephone interview.

Future prospects:

If the application's compliance measurements are consistent with the reference measurements, the system could provide an additional means of supporting compliance with medication. Finally, if the data on the user experience and the monthly reports drawn up by the application are positive, it could represent a quick and easy way for professionals to coordinate the management of patients followed at home.

Eligibility criteria: Inclusion Criteria:

Patient inclusion criteria:

* People aged over 65 receiving more than 5 chronic medications
* Person agreeing to take part in the study
* Person living at home receiving home nursing care as part of routine care
* Person whose carer is already a user of the application under study

Inclusion criteria for professionals:

* Home nurses who have been using the Medissimo nurse application for at least 1 month and who agree to take part in the study or
* Private practitioners who agree to take part in the study or
* Pharmacists who have been using the Medissimo nurse service for at least 1 month and who agree to take part in the study.

Exclusion Criteria:

Patient exclusion criteria:

* Refusal to take part in the study
* Person in palliative care
* Person under protection, guardianship or curatorship

Exclusion criteria for professionals:

- Refusal to take part in the study

Primary outcomes:
measure: Socio-demographic data (for all participants) Medical data
timeFrame: about 3 months
Secondary outcomes:
measure: Patient analyses : Pill counting
timeFrame: about 3 months
measure: Patient analyses : Recording of omissions in the monthly compliance report of patients taking part in the study
timeFrame: about 3 months
measure: Patient analyses : Morisky questionnaire
timeFrame: about 3 months
measure: Analysis of professionals : User experience analysis
timeFrame: about 3 months
measure: Analysis of professionals : Analysis of healthcare professionals' assessments
timeFrame: about 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Association Rivages
name: Joël Belmin, Professor
role: PRINCIPAL_INVESTIGATOR
References: