NCT06016101

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 29, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

August 29, 2023

Status Verified

August 1, 2023

Enrollment Period

6 months

First QC Date

August 9, 2023

Last Update Submit

August 24, 2023

Conditions

Keywords

Compliancemedication adherenceelectronic tooldigital healthe-healthuser's experienceelderly

Outcome Measures

Primary Outcomes (1)

  • Socio-demographic data (for all participants) Medical data

    Descriptive statistics on data (mean, standard deviation, median)

    about 3 months

Secondary Outcomes (5)

  • Patient analyses : Pill counting

    about 3 months

  • Patient analyses : Recording of omissions in the monthly compliance report of patients taking part in the study

    about 3 months

  • Patient analyses : Morisky questionnaire

    about 3 months

  • Analysis of professionals : User experience analysis

    about 3 months

  • Analysis of professionals : Analysis of healthcare professionals' assessments

    about 3 months

Study Arms (2)

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.

Other: 100 Patients

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.

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

Interventions

For patients and professionals: retrieval of socio-demographic data For patients : * Pill counting * Morisky questionnaire

100 Patients

For patients and professionals: retrieval of socio-demographic data For healthcare professionals : * Evaluation of user experience * Evaluation of the report produced by the application

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chronic DiseaseMedication AdherencePatient Compliance

Interventions

Health Personnel

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services

Study Officials

  • Joël Belmin, Professor

    Association Rivages

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joël Belmin, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2023

First Posted

August 29, 2023

Study Start

September 1, 2023

Primary Completion

March 1, 2024

Study Completion

April 1, 2024

Last Updated

August 29, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share