Investigating the Effect of an Information Video for Neck... | NCT02570659

Studies
Investigating the Effect of an Information Video for Neck Injuries in a Emergency Department Setting

NCT02570659

Sponsor

Karolinska Institutet

Status

Unknown status

Last Update Posted

Nov 20, 2017Actual

Enrollment

240Estimated

Phase

Not Applicable

Conditions

Whiplash Syndrome

Interventions

Information Video

Countries

Sweden

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

Nov 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

Jun 1, 2018Estimated

Completion Date

Jun 1, 2018Estimated

First Submitted Date

Oct 1, 2015

First Submission Date that Met QC Criteria

Oct 6, 2015

First Posted Date

Oct 7, 2015Estimated

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

Nov 16, 2017

Last Update Posted Date

Nov 20, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

A randomized controlled trial (RCT) to investigate the effect of a information video, consisting of a multiprofessional team, on patients with acute Whiplash Associated Disorder (WAD).

Detailed Description

Patients seeking medical care at Södersjukhuset Hospital, Sweden, after a motor vehicle accident resulting in neck trauma are offered to be included in the study. Inclusion criterias involve spine fractures, need for in house care, <18<65 years of age and low knowledge of the Swedish language.

A randomization is performed with two arms, one being "treatment as usual" i.e. an information folder with physiotherapeutic exercises, the other one being the Information Video.

The patients are contacted per telephone and a questionnaire with baseline data is sent via e-mail within a week after the accident. They also receive a link to the websites with the information.

The follow up time is 6 months and after that the patients receive a new questionnaire with questions regarding neck-specific status (WDQ), health related quality of life (SF-12) and pain.

The primary outcome is level of pain (NRS)

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

240Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Information Folder	No Intervention	A folder with advise and exercises used by physiotherapeutic clinic of Södersjukhuset Hospital (Treatment as usual)
Information Video	Experimental	A multiprofessional information video	Behavioral: Information Video

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Information Video	Behavioral	A 14 minutes intervention video explaining the mechanism of the injury from cross-professional point of view and physiotherapeutic advise	Information Video

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain	Self reported pain the last three days (NRS)	6 months

Secondary Outcomes

Measure	Description	Time Frame
Whiplash Disability Questionnaire (WDQ)		6 months
SF-12	Health related quality of life	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Knowledge of the swedish language
Traffic injury with neck pain

Exclusion Criteria:

Fractures
In house care needed

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eric Rydman	Recruiting	Stockholm			Sweden

Condition Browse Module

MeSH Terms

ID	Term
D014911	Whiplash Injuries

Ancestor Terms

ID	Term
D019838	Neck Injuries
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided