Crohn DiseaseNCT04754620
Distant Management of Crohn's Disease by Smartphones is Feasible and Effective Additionally it Reduces the Costs
A study testing real time online video visit in people with Crohn Disease, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
Evaluation of the feasibility, acceptability, patient satisfaction and economic benefits of smartphone video-based telehealth in the management of Crohn's disease patients Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- real time online video visit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2020to 1 Sep 2020
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The study group included patients with documented Crohn's disease, based on clinical, endoscopic, and histologic findings
- Patient between 18-80 years old
- Participants who have been receiving treatment for more than six months
Who cannot join
- Patients were excluded from the study if they had no internet connection
- Unable to use smartphones because of blindness, deafness, or mental disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kocaeli University Medical Faculty Hospital
İzmit, Kocaeli, 41001
About this study
Official title: Implementation and Evaluation of Smartphone-Based Videoconferance Telehealth for Patients With Crohn's Disease
Evaluation of the feasibility, acceptability, patient satisfaction and economic benefits of smartphone video-based telehealth in the management of Crohn's disease patients
Read the detailed description
Patients were examined by two gastroenterologists (HY, AED) either at a video conference based visit or face to face visit in outpatients clinics. We used the WhatsApp business application.The online visit notion was the same as traditional face-to-face visit except physical examination.
- Conditions
- Crohn Disease
- Being tested
- real time online video visit
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
real time online video visitOther
Participants have received an online visit by a smartphone application
| Study group | Role | What they receive |
|---|---|---|
| Standard face to face visit | No intervention | This group will receive a traditional outpatient visit |
| Online visit | Experimental | This group will receive a smartphone-based real-time video conference visit Receives: Other: real time online video visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction score with the video visits
Measurement of satisfaction with RAND Visit Specific Questionnaire (VSQ9),Minimum score "0" poor and maximum score is "5" represents excellent,
Measured: the day after the visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start1 Mar 2020
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan Yılmaz, Kocaeli University
- Investigators
- göktuğ şirin, Study director, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04754620
- Sponsor's protocol ID
- KouTeleH001
- Status last verified
- Feb 2021
- First submitted
- 5 Feb 2021
- Last updated
- 15 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Evaluation of Smartphone-Based Videoconferance Telehealth for Patients With Crohn's Disease
- ClinicalTrials.gov ID
- NCT04754620
- Acronym / sponsor ID
- KouTeleH001
- Conditions
- Crohn Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 15 Feb 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.
Evaluation of the feasibility, acceptability, patient satisfaction and economic benefits of smartphone video-based telehealth in the management of Crohn's disease patients
Detailed description
Patients were examined by two gastroenterologists (HY, AED) either at a video conference based visit or face to face visit in outpatients clinics. We used the WhatsApp business application.The online visit notion was the same as traditional face-to-face visit except physical examination.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard face to face visit | No intervention | –This group will receive a traditional outpatient visit |
| Online visit | Experimental | Other: real time online video visitThis group will receive a smartphone-based real-time video conference visit |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The study group included patients with documented Crohn's disease, based on clinical, endoscopic, and histologic findings
- Patient between 18-80 years old
- Participants who have been receiving treatment for more than six months
Key exclusion criteria (2 listed)
- Patients were excluded from the study if they had no internet connection
- Unable to use smartphones because of blindness, deafness, or mental disorders
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 |
|---|---|---|
| real time online video visitParticipants have received an online visit by a smartphone application | Other | Online visit |
Primary outcome
Satisfaction score with the video visits
Time frame: the day after the visit
Measurement of satisfaction with RAND Visit Specific Questionnaire (VSQ9),Minimum score "0" poor and maximum score is "5" represents excellent,
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 15 Feb 2021.
- Individual participant dataSharing planned: Yes
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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.
göktuğ şirin study director
Kocaeli University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing real time online video visit in people with Crohn Disease, run by Kocaeli University at 1 site in Turkey (Türkiye).
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 3 inclusion and 2 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 15 Feb 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 Turkey (Türkiye). 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?
Satisfaction score with the video visits (time frame: the day after the visit). 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 15 Feb 2021.