Distant Management of Crohn's Disease by Smartphones is F... | NCT04754620

Studies
Distant Management of Crohn's Disease by Smartphones is Feasible and Effective Additionally it Reduces the Costs

NCT04754620

Sponsor

Kocaeli University

Status

Completed

Last Update Posted

Feb 15, 2021Actual

Enrollment

139Actual

Phase

Not Applicable

Conditions

Crohn Disease

Interventions

real time online video visit

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2020Actual

Primary Completion Date

Sep 1, 2020Actual

Completion Date

Sep 1, 2020Actual

First Submitted Date

Feb 5, 2021

First Submission Date that Met QC Criteria

Feb 12, 2021

First Posted Date

Feb 15, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 12, 2021

Last Update Posted Date

Feb 15, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

139Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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	Other: real time online video visit

Interventions

Name	Type	Description	Arm Group Labels	Other Names
real time online video visit	Other	Participants have received an online visit by a smartphone application	Online visit

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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,	the day after the visit

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Patients were excluded from the study if they had no internet connection
Unable to use smartphones because of blindness, deafness, or mental disorders

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
göktuğ şirin	Kocaeli University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kocaeli University Medical Faculty Hospital		İzmit	Kocaeli	41001	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Analytic Code

Time Frame

Data will be available for one year after the study completed

Access Criteria

Public

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003424	Crohn Disease

Ancestor Terms

ID	Term
D015212	Inflammatory Bowel Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided