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 participants 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 persons status, and evaluated the injured perceptions of the patients 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
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
-
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.
-
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.