Vascular DiseasesAPPLIACNCT03968276
Study of the Interest of Patients Undergoing Anti-thrombotic Treatment in a Digital Application of Therapeutic Assistance
A study testing use of digital tablet in people with Vascular Diseases, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Medical ethics encourages medical personal to actively care for patients, however old they may be, if they have maintained their physical autonomy and mental integrity to travel the path of medical care together. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Diseases
- What is being tested?
- use of digital tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 21 Nov 2019to 10 Oct 2022
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient ≥ 18 years old
- Patient hospitalized in the vascular medicine department of the GHPSJ or attending a general medical consultation at the CMT
- Patient with at least one vascular pathology: pulmonary embolism, venous thrombosis or phlebitis, cardiac arrhythmia by atrial fibrillation, obliterating arteriopathy of the lower limbs or myocardial infarction
- Patient on antithrombotic treatment[anticoagulants : AVK or Anticoagulants Oraux Directs (AOD), or antiplatelet agents]
- Patient affiliated to a health insurance plan
- Patient able to read and understand the French language
- Patient capable of giving free, informed and express consent
Who cannot join
- Patient not residing in Ile de France
- Patient whose investigator considers that he/she is not able to use a digital tablet
- Patient deprived of liberty
- Patient under guardianship or curatorship
- Refusal to participate in the study
- Patient judged not to be included by the investigator on the basis of the inclusion questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
Medical ethics encourages medical personal to actively care for patients, however old they may be, if they have maintained their physical autonomy and mental integrity to travel the path of medical care together. Many of the patients are in this situation today and their age does not seem to be a limiting factor in the care required.
For more than 60 years, antithrombotics have played a major role in the management of thromboembolic and arterioatheromatous diseases. the doctors have therefore seen the advent of low molecular weight heparins, new platelet antiaggregants and then direct oral anticoagulants.
If their contribution is no longer discussed today, it is necessary to take into consideration the risks they cause, particularly in terms of haemorrhage. Indeed, antithrombotics are the leading cause of serious adverse reactions in France with anti-vitamins K (AVK) which are the leading cause of hospitalization for severe iatrogeny in France. This risk is increased by the coexistence of haemorrhagic risk factors: drug interaction, misuse, failure to comply with contraindications and precautions for use, especially as exposure to these drugs increases with age.
Read the detailed description
The risk of bleeding varies in different populations and according to the treatment used. Severe bleeding under AVK has an incidence of 0.6 to 10% per year. Fatal hemorrhage is in the order of 1%. The risk factors for bleeding are controversial: history of bleeding in the patient, instability of the International Normalized Ratio (INR) at the time of introduction of KVAs and during the first few months, poor patient compliance, drug combinations (antiplatelet, non-steroidal anti-inflammatory drugs: NSAIDs, paracetamol, etc.) or association with alcohol. National pharmacovigilance data indicate that serious accidents are not uncommon due to frequent misuse of antithrombotics in common practice.
There are risk factors related to the patient and his or her comorbidities: history of bleeding, stroke, comorbidities such as age > 65 years, diabetes, cancer, chronic renal failure.
Despite the various aids to therapeutic patient education (surveillance logbook, computerised INR monitoring), there has been no decrease in the frequency of iatrogenic accidents, either in hospitals or in urban medicine.
The use of smartphone applications in the medical field is increasingly evolving among healthcare professionals and patients. They allow for more personalized care, and can also promote interaction with health professionals.
Strengthening the link between specialist doctors and the general practitioner for joint patient management will improve their follow-up and reduce the risk of iatrogeny.
In 2016, a survey was conducted in the vascular medicine department of the Groupe Hospitalier Paris Saint-Joseph (GHPSJ) to assess access to smartphones among patients on anti-thrombotic medication. Of the 100 patients enrolled, 74 were on anticoagulant or platelet aggregation therapy. Of these, 50 had a mobile phone and 24% used the Internet and made downloads to their phones.
This raises the question of the interest that patients might have in a mobile application on the use of anti-thrombotics. As the profile of patients seen in hospital is different from those consulting in general medicine, it seems interesting to study these two populations in order to know if there is a difference in their attitude towards the smartphone.
In order to find a new way to limit the iatrogeny of antithrombotic drugs, the investigators wanted to set up a medical application (educational tablet) for patients to provide them with support to better manage their treatment.
- Conditions
- Vascular Diseases
- Being tested
- use of digital tablet
- Keywords
- antithrombotic treatment, digital therapeutic application assistance
- Medical subject headings
- Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use of digital tabletOther
At the end of hospitalization, the patient has an educational tablet at his disposal for 1 month at home. Throughout its use, the patient may contact the investigating physician via a telephone number available within the application if he/she encounters a problem related to the study. At the end of this month, the patient must complete two questionnaires through the application to assess his or her knowledge of his or her condition and treatment, as well as his or her satisfaction with the use of the tablet.
In this research, 1 month after inclusion, the patient will have an additional follow-up visit corresponding to a dedicated consultation in the vascular medicine department. It will allow the patient to review the use of the tablet and his or her satisfaction with the use of such a tool.
| Study group | Role | What they receive |
|---|---|---|
| use of digital tablet | Experimental | if the patient is included in the study, an educational tablet (digital tablet) is given to the patient.
The first connection to the tablet and then to the "My medication protects my vessels" application is made by the investigator in the presence of the patient. The application is configured by the investigator with the choice of the vascular pathology(s) corresponding to the patient included and the prescribed anti-thrombotic treatments. Thus, for each patient, the content of the tablet is adapted and personalized according to his vascular profile.
After discharge from hospital, the patient has the educational tablet at his disposal for 1 month at home. The application offers patients various information supports (tools, questionnaires and pill box). Throughout its use, it may contact the investigating physician via a telephone number available within the application if it encounters a problem related to the study. Receives: Other: use of digital tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return of the tablet in working order and to its use
return (yes/no) and use
Measured: 1 month
Secondary outcomes (6)
Number of pages consulted on the educational tablet
Measured: 1 month
Analyses of patient treatment knowledge assessment questionnaires
The two questionnaires contain 12 and 11 questions respectively. the possible answers are yes or no
Measured: Day 0 - 1 month
Analogical visual scale of patient satisfaction
Analogical visual scale of patient satisfaction from minimum 0 (very satisfied) to maximum 10 (not satisfied)
Measured: 1 month
Questionnaire on compliance with antithrombotic treatments on application
taking antithrombotic treatments (yes/no)
Measured: 1 month
Reporting of adverse events via the dedicated field on the educational tablet
Measured: 1 month
Number of calls from city physicians and pharmacists received by the investigator
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start21 Nov 2019
- Primary completion10 Oct 2022
- Study completion10 Oct 2022
Why it stopped: The PI decided to stop the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vascular DiseasesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Parinaz GHAFFARI, MD, Study director, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03968276
- Sponsor's protocol ID
- APPLIAC
- Acronym
- APPLIAC
- Status last verified
- Oct 2022
- First submitted
- 27 May 2019
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Linkins LA, Choi PT, Douketis JD. Clinical impact of bleeding in patients taking oral anticoagulant therapy for venous thromboembolism: a meta-analysis. Ann Intern Med. 2003 Dec 2;139(11):893-900. doi: 10.7326/0003-4819-139-11-200312020-00007.
PubMed 14644891Dahri K, Loewen P. The risk of bleeding with warfarin: a systematic review and performance analysis of clinical prediction rules. Thromb Haemost. 2007 Nov;98(5):980-7.
PubMed 18000602
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Interest of Patients Undergoing Anti-thrombotic Treatment in a Digital Application of Therapeutic Assistance
- ClinicalTrials.gov ID
- NCT03968276
- Acronym / sponsor ID
- APPLIAC / APPLIAC
- Conditions
- Vascular Diseases
- Keywords
- antithrombotic treatment, digital therapeutic application assistance
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The PI decided to stop the study.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 21 Nov 2019 (actual)
- Primary completion
- 10 Oct 2022 (actual)
- Study completion
- 10 Oct 2022 (actual)
- First posted
- 30 May 2019 (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.
Medical ethics encourages medical personal to actively care for patients, however old they may be, if they have maintained their physical autonomy and mental integrity to travel the path of medical care together. Many of the patients are in this situation today and their age does not seem to be a limiting factor in the care required.
For more than 60 years, antithrombotics have played a major role in the management of thromboembolic and arterioatheromatous diseases. the doctors have therefore seen the advent of low molecular weight heparins, new platelet antiaggregants and then direct oral anticoagulants.
If their contribution is no longer discussed today, it is necessary to take into consideration the risks they cause, particularly in terms of haemorrhage. Indeed, antithrombotics are the leading cause of serious adverse reactions in France with anti-vitamins K (AVK) which are the leading cause of hospitalization for severe iatrogeny in France. This risk is increased by the coexistence of haemorrhagic risk factors: drug interaction, misuse, failure to comply with contraindications and precautions for use, especially as exposure to these drugs increases with age.
Detailed description
The risk of bleeding varies in different populations and according to the treatment used. Severe bleeding under AVK has an incidence of 0.6 to 10% per year. Fatal hemorrhage is in the order of 1%. The risk factors for bleeding are controversial: history of bleeding in the patient, instability of the International Normalized Ratio (INR) at the time of introduction of KVAs and during the first few months, poor patient compliance, drug combinations (antiplatelet, non-steroidal anti-inflammatory drugs: NSAIDs, paracetamol, etc.) or association with alcohol. National pharmacovigilance data indicate that serious accidents are not uncommon due to frequent misuse of antithrombotics in common practice.
There are risk factors related to the patient and his or her comorbidities: history of bleeding, stroke, comorbidities such as age > 65 years, diabetes, cancer, chronic renal failure.
Despite the various aids to therapeutic patient education (surveillance logbook, computerised INR monitoring), there has been no decrease in the frequency of iatrogenic accidents, either in hospitals or in urban medicine.
The use of smartphone applications in the medical field is increasingly evolving among healthcare professionals and patients. They allow for more personalized care, and can also promote interaction with health professionals.
Strengthening the link between specialist doctors and the general practitioner for joint patient management will improve their follow-up and reduce the risk of iatrogeny.
In 2016, a survey was conducted in the vascular medicine department of the Groupe Hospitalier Paris Saint-Joseph (GHPSJ) to assess access to smartphones among patients on anti-thrombotic medication. Of the 100 patients enrolled, 74 were on anticoagulant or platelet aggregation therapy. Of these, 50 had a mobile phone and 24% used the Internet and made downloads to their phones.
This raises the question of the interest that patients might have in a mobile application on the use of anti-thrombotics. As the profile of patients seen in hospital is different from those consulting in general medicine, it seems interesting to study these two populations in order to know if there is a difference in their attitude towards the smartphone.
In order to find a new way to limit the iatrogeny of antithrombotic drugs, the investigators wanted to set up a medical application (educational tablet) for patients to provide them with support to better manage their treatment.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| use of digital tablet | Experimental | Other: use of digital tabletif the patient is included in the study, an educational tablet (digital tablet) is given to the patient. The first connection to the tablet and then to the "My medication protects my vessels" application is made by the investigator in the presence of the patient. The application is configured by the investigator with the choice of the vascular pathology(s) corresponding to the patient included and the prescribed anti-thrombotic treatments. Thus, for each patient, the content of the tablet is adapted and personalized according to his vascular profile. After discharge from hospital, the patient has the educational tablet at his disposal for 1 month at home. The application offers patients various information supports (tools, questionnaires and pill box). Throughout its use, it may contact the investigating physician via a telephone number available within the application if it encounters a problem related to the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient ≥ 18 years old
- Patient hospitalized in the vascular medicine department of the GHPSJ or attending a general medical consultation at the CMT
- Patient with at least one vascular pathology: pulmonary embolism, venous thrombosis or phlebitis, cardiac arrhythmia by atrial fibrillation, obliterating arteriopathy of the lower limbs or myocardial infarction
- Patient on antithrombotic treatment[anticoagulants : AVK or Anticoagulants Oraux Directs (AOD), or antiplatelet agents]
- Patient affiliated to a health insurance plan
Key exclusion criteria (6 listed)
- Patient not residing in Ile de France
- Patient whose investigator considers that he/she is not able to use a digital tablet
- Patient deprived of liberty
- Patient under guardianship or curatorship
- Refusal to participate 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 |
|---|---|---|
| use of digital tabletAt the end of hospitalization, the patient has an educational tablet at his disposal for 1 month at home. Throughout its use, the patient may contact the investigating physician via a telephone number available within the application if he/she encounters a problem related to the study. At the end of this month, the patient must complete two questionnaires through the application to assess his or her knowledge of his or her condition and treatment, as well as his or her satisfaction with the use of the tablet. In this research, 1 month after inclusion, the patient will have an additional follow-up visit corresponding to a dedicated consultation in the vascular medicine department. It will allow the patient to review the use of the tablet and his or her satisfaction with the use of such a tool. | Other | use of digital tablet |
Primary outcome
Return of the tablet in working order and to its use
Time frame: 1 month
return (yes/no) and use
6 secondary outcomes
Number of pages consulted on the educational tablet
Time frame: 1 month
Analyses of patient treatment knowledge assessment questionnaires
Time frame: Day 0 - 1 month
Analogical visual scale of patient satisfaction
Time frame: 1 month
Questionnaire on compliance with antithrombotic treatments on application
Time frame: 1 month
Reporting of adverse events via the dedicated field on the educational tablet
Time frame: 1 month
Number of calls from city physicians and pharmacists received by the investigator
Time frame: 1 month
Results and safety
The study was stopped early (reason given: The PI decided to stop the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Results publication: PubMed 14644891Linkins LA, Choi PT, Douketis JD. Clinical impact of bleeding in patients taking oral anticoagulant therapy for venous thromboembolism: a meta-analysis. Ann Intern Med. 2003 Dec 2;139(11):893-900. doi: 10.7326/0003-4819-139-11-200312020-00007.
- Results publication: PubMed 18000602Dahri K, Loewen P. The risk of bleeding with warfarin: a systematic review and performance analysis of clinical prediction rules. Thromb Haemost. 2007 Nov;98(5):980-7.
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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.
Parinaz GHAFFARI, MD study director
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing use of digital tablet in people with Vascular Diseases, run by Fondation Hôpital Saint-Joseph at 1 site in France.
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 7 inclusion and 6 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: stopped early, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: The PI decided to stop the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return of the tablet in working order and to its use (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03968276, which also lists 2 linked publications.
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 2 Nov 2022.