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

Chronic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06016101
• Other study ID #: 2023-A00948-37
• Status: Not yet recruiting
• Start date: September 2023
• Est. completion date: April 1, 2024

Study information

• Verified date: August 2023
• Source: RIVAGES
• Contact: Joël Belmin, Professor
• Phone: +33149594565
• Email: j.belmin[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: April 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Elderly Person
• Medication Compliance
• Polypathology

Intervention

Other:
• 100 Patients
For patients and professionals: retrieval of socio-demographic data For patients : Pill counting Morisky questionnaire
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
RIVAGES

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Socio-demographic data (for all participants) Medical data	Descriptive statistics on data (mean, standard deviation, median)	about 3 months
Secondary	Patient analyses : Pill counting	Blant and Altman diagram to estimate the agreement between the two measurements (pill count and missed doses): determine the difference between the measurements for each mode of observation. The mean difference between the two measurements will be used to determine the bias. We will also try to assess the precision, which estimates the dispersion of the absolute bias. Precision will be estimated by the 95% agreement limits.	about 3 months
Secondary	Patient analyses : Recording of omissions in the monthly compliance report of patients taking part in the study	Blant and Altman diagram to estimate the agreement between the two measurements (pill count and missed doses): determine the difference between the measurements for each mode of observation. The mean difference between the two measurements will be used to determine the bias. We will also try to assess the precision, which estimates the dispersion of the absolute bias. Precision will be estimated by the 95% agreement limits.	about 3 months
Secondary	Patient analyses : Morisky questionnaire	Cohen's Kappa test: used to measure Morisky's score, and to test the concordance between the good adherence/average adherence/low adherence classification and the classification from the Medissimo application. We set the threshold for Cohen's Kappa test at 0.80, which corresponds to very good agreement.	about 3 months
Secondary	Analysis of professionals : User experience analysis	Qualitative analysis : Evaluation of user experimentation using the SUS (Sytem usability scale) questionnaire. This is an easy-to-use Likert-type scale comprising 10 questions. The aim is to evaluate the point of view of the Medissimo nurse user, after having had the opportunity to use it. The questions offer quick answers, ranging from "strongly disagree" to "strongly agree". The degree of acceptability, highlighted in the study by Bangor and al. (2009), is as follows: Between 0 and 50: not acceptable; Between 50 and 60: Acceptability likely, but low; Between 60 and 70: Acceptability likely, high; Between 70 and 100: Acceptable	about 3 months
Secondary	Analysis of professionals : Analysis of healthcare professionals' assessments	Qualitative analysis : This is a "likert" type questionnaire designed by the investigator specifically for this study. This 12-item questionnaire will be used to obtain feedback from healthcare professionals on the monthly reports produced by the application for nurses. The questionnaire consists of : 10 closed questions; 2 open questions with short answers	about 3 months