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ISRCTN
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ISRCTN11746866
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ClinicalTrials.gov identifier
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Public title
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Injured road user's health-related quality of life after telephone intervention
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Scientific title
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Injured road user's health-related quality of life after telephone intervention: a randomised controlled trial
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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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.
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Ethics approval
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Ethics Committee, Umeå University, approved on 19/02/2003 (ref: dnr 03-079)
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Study design
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Randomised controlled trial
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Countries of recruitment
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Sweden
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Disease/condition/study domain
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Quality of life after road injury
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Participants - inclusion criteria
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1. Both males and females, age 18-70 years
2. Member of one of the three road user categories:
a. Car occupants
b. Cyclists
c. Pedestrians
3. Having attended the emergency department of the Umeå University Hospital after an injury event in the traffic environment
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Participants - exclusion criteria
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Diagnosis of dementia or mental illness
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Anticipated start date
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01/04/2003
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Anticipated end date
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30/04/2005
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Status of trial
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Completed
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Patient information material
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Target number of participants
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600
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Interventions
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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.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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The Swedish Association for Cancer and Traffic Victims (Sweden)
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Trial website
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Publications
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2008 results in http://www.ncbi.nlm.nih.gov/pubmed/19120736
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Contact name
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Prof
Ulf
Björnstig
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Address
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Department of Surgical and Perioperative Sciences
Division of Surgery
Umeå University
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City/town
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Umeå
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Zip/Postcode
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S-901 87
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Country
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Sweden
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Tel
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+46 70 530 4377
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Email
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ulf.bjornstig@vll.se
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Sponsor
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Umeå University (Sweden)
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Address
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c/o Dr Carin Franzén
Department of Nursing
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City/town
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Umeå
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Zip/Postcode
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S-901 87
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Country
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Sweden
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Tel
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+46 70 530 4377
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Email
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carin.franzen@nurs.umu.se
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Sponsor website:
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http://www.umu.se/english
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Date applied
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08/11/2008
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Last edited
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12/01/2009
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Date ISRCTN assigned
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02/01/2009
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