Digital ApplicationNCT06016101
Usefulness of the Medissimo Nurse Application for Supporting Medication Compliance in Elderly People With Chronic Polypathologies
An observational study of Digital Application and Elderly Person, run by RIVAGES.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Digital Application, Elderly Person, Chronic Disease
- What is being tested?
- 100 Patients and Healthcare professionals (20 doctors, 20 pharmacists and 20 nurses)
- Type of treatment
- Pill or oral medicine
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to 1 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
- 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.
Who cannot join
- Patient 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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
- Being tested
- 100 Patients, Healthcare professionals (20 doctors, 20 pharmacists and 20 nurses)
- Keywords
- Compliance, medication adherence, electronic tool, digital health, e-health, user's experience, elderly
- Medical subject headings
- Chronic Disease, Medication Adherence, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
100 PatientsOther
For patients and professionals: retrieval of socio-demographic data
For patients :
- Pill counting
- Morisky questionnaire
Healthcare professionals (20 doctors, 20 pharmacists and 20 nurses)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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Healthcare professionals (20 doctors, 20 pharmacists and 20 nurses) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Socio-demographic data (for all participants) Medical data
Descriptive statistics on data (mean, standard deviation, median)
Measured: about 3 months
Secondary outcomes (5)
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.
Measured: about 3 months
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.
Measured: about 3 months
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.
Measured: about 3 months
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
Measured: about 3 months
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
Measured: about 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study startSep 2023 (estimated)
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digital ApplicationStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RIVAGES
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joël Belmin, Professor, Principal investigator, Association Rivages
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06016101
- Sponsor's protocol ID
- 2023-A00948-37
- Status last verified
- Aug 2023
- First submitted
- 9 Aug 2023
- Last updated
- 29 Aug 2023
- Results posted
- 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 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of the Medissimo Nurse Application for Supporting Medication Compliance in Elderly People With Chronic Polypathologies
- ClinicalTrials.gov ID
- NCT06016101
- Acronym / sponsor ID
- 2023-A00948-37
- Conditions
- Digital Application, Elderly Person, Chronic Disease, Polypathology, Medication Compliance
- Keywords
- Compliance, medication adherence, electronic tool, digital health, e-health, user's experience, elderly
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- RIVAGESUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 29 Aug 2023 (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.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 100 Patients | – | Other: 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. |
| Healthcare professionals (20 doctors, 20 pharmacists and 20 nurses) | – | Other: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- Refusal to take part in the study
- Person in palliative care
- Person under protection, guardianship or curatorship
- Refusal to take part in the study
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 |
|---|---|---|
| 100 PatientsFor patients and professionals: retrieval of socio-demographic data For patients : * Pill counting * Morisky questionnaire | Other | 100 Patients |
| 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 | Other | Healthcare professionals (20 doctors, 20 pharmacists and 20 nurses) |
Primary outcome
Socio-demographic data (for all participants) Medical data
Time frame: about 3 months
Descriptive statistics on data (mean, standard deviation, median)
5 secondary outcomes
Patient analyses : Pill counting
Time frame: about 3 months
Patient analyses : Recording of omissions in the monthly compliance report of patients taking part in the study
Time frame: about 3 months
Patient analyses : Morisky questionnaire
Time frame: about 3 months
Analysis of professionals : User experience analysis
Time frame: about 3 months
Analysis of professionals : Analysis of healthcare professionals' assessments
Time frame: about 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- 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. This study is not recruiting at the moment.
Joël Belmin, Professor principal investigator
Association Rivages
Questions about this trial
What is this clinical trial studying?
An observational study of Digital Application and Elderly Person, run by RIVAGES.
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 8 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joël Belmin, Professor (+33149594565, j.belmin@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Socio-demographic data (for all participants) Medical data (time frame: about 3 months). 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 29 Aug 2023.