Wound Healing DisorderNCT05098314
Impact of Personalized Interventions to Raise Teleconsultation Awareness in EHPAD
An observational study of Wound Healing Disorder, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The cicat-occitanie network offers expertise for health professionals concerning wound care, in particular through teleconsultations. This study aimed to understand the obstacles reported by healthcare professionals in Lozere's EHPAD related to the use of this network. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Wound Healing Disorder
- What is being tested?
- Personalized interventions regarding the Cicat-Occitanie network
- How many people
- 1,612 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2018to 17 Sep 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All residents of Lozère's EHPADs
Who may be able to join
- Be a resident in Lozère's EHPAD
Who cannot join
- Patient who reject the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Personalized Interventions to Raise Teleconsultation Awareness: The Case of the Cicat-Occitanie Network and Healthcare Professionals in Lozère's EHPADs
The cicat-occitanie network offers expertise for health professionals concerning wound care, in particular through teleconsultations. This study aimed to understand the obstacles reported by healthcare professionals in Lozere's EHPAD related to the use of this network. This cluster randomized controlled trial also sought to evaluate the effect of personalized intervention for each EHPAD on the use of this network.
- Conditions
- Wound Healing Disorder
- Being tested
- Personalized interventions regarding the Cicat-Occitanie network
- Keywords
- telemedicine, Cluster Randomised Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized interventions regarding the Cicat-Occitanie networkOther
First of all, healthcare professionals from EHPAD in the intervention arm were invited by email to answer a closed questionnaire. It was built by the authors, on Google forms, and consisted of 11 questions divided into 2 sections.
Section 1 collected data about the participants. In section 2, they were asked to score from 0 to 4 (ranging from "not at all "to" a lot ") the various obstacles to teleconsultations reported by the literature.
| Study group | Role | What they receive |
|---|---|---|
| EHPAD with personalized interventions | EHPAD with personalized interventions. Receives: Other: Personalized interventions regarding the Cicat-Occitanie network | |
| EHPAD without personalized interventions | EHPAD without personalized interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Requests rate for teleconsultations
Requests rate for teleconsultations with the Cicat-Occitanie network by Lozère's EHAPDs.
Incidence in resident-year of new requests of teleconsultations from the Cicat-Occitanie network by health professionals from Lozère's EHPADs. Calculated via numbers transmitted by the Cicat-Occitanie network 3 months after the intervention and the number of residents in each EHPAD.
Measured: 3 months
Secondary outcomes (3)
Human obstacles linked to the use of teleconsultations
Human obstacles linked to the use of teleconsultations with the Cicat-Occitanie network reported by health professionals in Lozère's EHPAD Rating of the different human obstacles from 0 to 4 (not at all to a lot) by the health professionals in EHPAD of Lozère. This was collected through an online questionnaire.
Measured: 4 months
Organizational obstacles linked to the use of teleconsultations
Organizational obstacles linked to the use of teleconsultations from the Cicat-Occitanie network reported by health professionals in Lozère's EHPAD.
Rating of the different organizational obstacles from 0 to 4 (not at all to a lot) by the health professionals in EHPAD of Lozère. This was collected through an online questionnaire.
Measured: 4 months
Economic obstacles linked to the use of teleconsultations
Economic obstacles linked to the use of teleconsultations from the Cicat-Occitanie network reported by health professionals in Lozère's EHPAD.
Rating of the different obstacles from 0 to 4 (not at all to a lot) by the health professionals in EHPAD of Lozère. This was collected through an online questionnaire.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start1 Sep 2018
- Primary completion1 Jun 2021
- Study completion17 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound Healing DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 1,612 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bastien Paul, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05098314
- Sponsor's protocol ID
- RECHMPL21_0373
- Status last verified
- Oct 2021
- First submitted
- 18 Oct 2021
- Last updated
- 5 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Personalized Interventions to Raise Teleconsultation Awareness: The Case of the Cicat-Occitanie Network and Healthcare Professionals in Lozère's EHPADs
- ClinicalTrials.gov ID
- NCT05098314
- Acronym / sponsor ID
- RECHMPL21_0373
- Conditions
- Wound Healing Disorder
- Keywords
- telemedicine, Cluster Randomised Trial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,612 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 17 Sep 2021 (actual)
- First posted
- 28 Oct 2021 (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.
The cicat-occitanie network offers expertise for health professionals concerning wound care, in particular through teleconsultations. This study aimed to understand the obstacles reported by healthcare professionals in Lozere's EHPAD related to the use of this network. This cluster randomized controlled trial also sought to evaluate the effect of personalized intervention for each EHPAD on the use of this network.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EHPAD with personalized interventions | – | Other: Personalized interventions regarding the Cicat-Occitanie networkEHPAD with personalized interventions. |
| EHPAD without personalized interventions | – | –EHPAD without personalized interventions |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All residents of Lozère's EHPADs
Key inclusion criteria (1 listed)
- Be a resident in Lozère's EHPAD
Key exclusion criteria (1 listed)
- Patient who reject the study protocol
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 |
|---|---|---|
| Personalized interventions regarding the Cicat-Occitanie networkFirst of all, healthcare professionals from EHPAD in the intervention arm were invited by email to answer a closed questionnaire. It was built by the authors, on Google forms, and consisted of 11 questions divided into 2 sections. Section 1 collected data about the participants. In section 2, they were asked to score from 0 to 4 (ranging from "not at all "to" a lot ") the various obstacles to teleconsultations reported by the literature. | Other | EHPAD with personalized interventions |
Primary outcome
Requests rate for teleconsultations
Time frame: 3 months
Requests rate for teleconsultations with the Cicat-Occitanie network by Lozère's EHAPDs. Incidence in resident-year of new requests of teleconsultations from the Cicat-Occitanie network by health professionals from Lozère's EHPADs. Calculated via numbers transmitted by the Cicat-Occitanie network 3 months after the intervention and the number of residents in each EHPAD.
3 secondary outcomes
Human obstacles linked to the use of teleconsultations
Time frame: 4 months
Organizational obstacles linked to the use of teleconsultations
Time frame: 4 months
Economic obstacles linked to the use of teleconsultations
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
- Individual participant dataSharing planned: Undecided. NC
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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.
Bastien Paul principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wound Healing Disorder, run by University Hospital, Montpellier 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 5 Nov 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Requests rate for teleconsultations (time frame: 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 5 Nov 2021.