Condition category
Injury, Occupational Diseases, Poisoning
Date applied
08/11/2008
Date assigned
02/01/2009
Last edited
04/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ulf Björnstig

ORCID ID

Contact details

Department of Surgical and Perioperative Sciences
Division of Surgery
Umeå University
Umeå
S-901 87
Sweden
+46 70 530 4377
ulf.bjornstig@vll.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Injured road user's health-related quality of life after telephone intervention: a randomised controlled trial

Acronym

Study hypothesis

To assess whether injured road users, aged 18-70 years, who received nursing intervention via telephone follow-up after the injury, would have higher levels of health-related quality of life than those who did not receive such intervention.

Ethics approval

Ethics Committee, Umeå University, approved on 19/02/2003 (ref: dnr 03-079)

Study design

Randomised controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Quality of life after road injury

Intervention

The participants were randomly allocated to the intervention and control groups (1:1 randomisation ratio). The intervention group received routine care and nursing via telephone follow-up three weeks after discharge, while the control group received routine care only.

The intervention consisted of a telephone contact with a registered nurse who had a background in emergency care. The nurse initiated the contact by telephone three weeks after discharge from hospital. The dialogue was focused on the participant’s current situation and experiences of the injury. An open introductory question was asked: " How do you feel, and how have things been for you?" The nurse used open questions to enquire about the injured person’s status, and evaluated the injured perceptions of the patient’s situation. After the first telephone contact, members of the intervention group were permitted to call the nurse at any time during the six months if they had any injury-related problems.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Health-related quality of life, assessed by the Euroqol EQ-5D (mail survey) at baseline in both study arms, at three months in the intervention arm only and six months in both study arms.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/04/2003

Overall trial end date

30/04/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Both males and females, age 18-70 years
2. Member of one of the three road user categories:
2.1. Car occupants
2.2. Cyclists
2.3. Pedestrians
3. Having attended the emergency department of the Umeå University Hospital after an injury event in the traffic environment

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

600

Participant exclusion criteria

Diagnosis of dementia or mental illness

Recruitment start date

01/04/2003

Recruitment end date

30/04/2005

Locations

Countries of recruitment

Sweden

Trial participating centre

Department of Surgical and Perioperative Sciences
Umeå
S-901 87
Sweden

Sponsor information

Organisation

Umeå University (Sweden)

Sponsor details

c/o Dr Carin Franzén
Department of Nursing
Umeå
S-901 87
Sweden
+46 70 530 4377
carin.franzen@nurs.umu.se

Sponsor type

University/education

Website

http://www.umu.se/english

Funders

Funder type

Other

Funder name

The Swedish Association for Cancer and Traffic Victims (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/19120736
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19515265

Publication citations

  1. Results

    Franzén C, Brulin C, Stenlund H, Björnstig U, Injured road users' health-related quality of life after telephone intervention: a randomised controlled trial., J Clin Nurs, 2009, 18, 1, 108-116, doi: 10.1111/j.1365-2702.2008.02436.x.

  2. Results

    Franzén C, Björnstig U, Brulin C, Lindholm L, A cost-utility analysis of nursing intervention via telephone follow-up for injured road users., BMC Health Serv Res, 2009, 9, 98, doi: 10.1186/1472-6963-9-98.

Additional files

Editorial Notes