Usefulness of the Medissimo Nurse Application for Supporting Medication Compliance in Elderly People With Chronic Polypathologies

NCT ID: NCT06016101

Last Updated: 2023-08-29

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 160 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-30
• Study Completion Date: 2024-04-01

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.

Conditions

Digital Application; Elderly Person; Chronic Disease; Polypathology; Medication Compliance

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Study Groups

100 Patients

• Socio-demographic data (age, gender, lifestyle, medication management aids)
• Medical data (number and type of medications)
• Variables for calculating assessment criteria:

< Pill count: this is a simple way of estimating compliance with medication. The pharmacist will calculate the pill count. The remaining pills (not taken by the patient) are brought to the pharmacist, who then calculates them. The pill count is not used as part of routine care for Medipac beneficiaries.

< The Morisky adherence questionnaire is an 8-item hetero-questionnaire used to measure adherence to treatment. It will be carried out by the home care nurse as part of routine care. The scores can be interpreted as follows: ≥ 8: good adherence; 6 to 7: average adherence; < 6: poor adherence.

100 Patients

Intervention Type: OTHER

For patients and professionals: retrieval of socio-demographic data

For patients :

• Pill counting
• Morisky questionnaire

Healthcare professionals (20 doctors, 20 pharmacists and 20 nurses)

• Socio-demographic data (age, gender, profession)
• Evaluation of the user experience using the SUS (Sytem usability scale) questionnaire. This is an easy-to-use Likert-type scale consisting of 10 questions. The aim is to assess the point of view of the person using the Medissimo nurse application, after having had the opportunity to use it. The questions offer quick answers, ranging from "strongly disagree" to "strongly agree".
• Assessment of the monthly reports produced by the application for nurses, GPs and pharmacists. Using a Likert-type questionnaire, they will be asked to describe their satisfaction, and the beneficial or negative aspects of this application in relation to patient monitoring. The questionnaire consists of 12 questions, 10 of which offer the following 5 responses: "Strongly agree"; "Agree"; "Neither disagree nor agree"; "Disagree"; "Strongly disagree", and 2 short-answer, open-ended questions.

Healthcare professionals (20 doctors, 20 pharmacists and 20 nurses)

Intervention Type: OTHER

For patients and professionals: retrieval of socio-demographic data

For healthcare professionals :

• Evaluation of user experience
• Evaluation of the report produced by the application

Interventions

100 Patients

For patients and professionals: retrieval of socio-demographic data

For patients :

• Pill counting
• Morisky questionnaire

Intervention Type: OTHER

Healthcare professionals (20 doctors, 20 pharmacists and 20 nurses)

For patients and professionals: retrieval of socio-demographic data

For healthcare professionals :

• Evaluation of user experience
• Evaluation of the report produced by the application

Intervention Type: OTHER

Eligibility Criteria

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

• 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

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

• Refusal to take part in the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

RIVAGES

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joël Belmin, Professor

Role: PRINCIPAL_INVESTIGATOR

Association Rivages

Central Contacts

Joël Belmin, Professor

Role: CONTACT

j.belmin@aphp.fr

+33149594565

Other Identifiers

2023-A00948-37

Identifier Type: -

Identifier Source: org_study_id