Video Consultation During Follow up Surgical Care | NCT04538677

Studies
Video Consultation During Follow up Surgical Care

NCT04538677

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status

Completed

Last Update Posted

Sep 4, 2020Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Colorectal Cancer

Interventions

Video consultation

Countries

Netherlands

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

Aug 2020

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

Jun 1, 2017Actual

Primary Completion Date

Aug 23, 2017Actual

Completion Date

Aug 23, 2017Actual

First Submitted Date

Aug 31, 2020

First Submission Date that Met QC Criteria

Sep 3, 2020

First Posted Date

Sep 4, 2020Actual

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

Sep 3, 2020

Last Update Posted Date

Sep 4, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. dr. W.A. Bemelman, Prof. dr., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Principal Investigator

Lead Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)OTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

The aim of this study was to compare the willingness to use and attitude towards VC amongst both patients with colorectal cancer and healthcare providers during follow up care. Second, to determine the satisfaction with the quality of the healthcare provider and the usability of the used VC technology. 50 patients will be asked to choose between video consultation or face-to-face contact at the outpatient surgical clinic.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
F2F-Group		Patients who preferred a traditional F2F-appointment were seen at the outpatient clinic.
VC-group		Patients who preferred a video consult were seen over a video connection.	Device: Video consultation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Video consultation	Device	A two-way audio and visual connection between patients and surgeons	VC-group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Attitude and satisfaction with video consultation	PAT-VC questionnaire	Immediately after the consult

Secondary Outcomes

Measure	Description	Time Frame
Usability of the video consultation technology	SUS questionnaire	Immediately after the test consult
Quality of provided care by surgeon: MSF questionnaire	MSF questionnaire

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 years or older
Fluent in speaking and writing in Dutch
Follow up appointments in which overall progress, new complaints, results with good news and treatment was discussed were considered feasible.

Exclusion Criteria:

Introductory appointments
Bad news consultations
Physical examination needed
No access to Internet
No access to a smartphone, tablet or computer with a camera
Not willing to activate their electronic patient portal

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with colorectal cancer scheduled for appointment at the surgical oncology outpatient a tertiary referral center.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Amsterdam UMC, location AMC		Amsterdam			Netherlands

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided