Injured road user's health-related quality of life after telephone intervention
| ISRCTN | ISRCTN11746866 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11746866 |
| Secondary identifying numbers | N/A |
- Submission date
- 08/11/2008
- Registration date
- 02/01/2009
- Last edited
- 04/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Ulf Björnstig
Scientific
Scientific
Department of Surgical and Perioperative Sciences
Division of Surgery
Umeå University
Umeå
S-901 87
Sweden
| Phone | +46 70 530 4377 |
|---|---|
| ulf.bjornstig@vll.se |
Study information
| Study design | Randomised controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | Injured road user's health-related quality of life after telephone intervention: a randomised controlled trial |
| Study objectives | 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(s) | Ethics Committee, Umeå University, approved on 19/02/2003 (ref: dnr 03-079) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/04/2003 |
| Completion date | 30/04/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 600 |
| Key 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 |
| Key exclusion criteria | Diagnosis of dementia or mental illness |
| Date of first enrolment | 01/04/2003 |
| Date of final enrolment | 30/04/2005 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Department of Surgical and Perioperative Sciences
Umeå
S-901 87
Sweden
S-901 87
Sweden
Sponsor information
Umeå University (Sweden)
University/education
University/education
c/o Dr Carin Franzén
Department of Nursing
Umeå
S-901 87
Sweden
| Phone | +46 70 530 4377 |
|---|---|
| carin.franzen@nurs.umu.se | |
| Website | http://www.umu.se/english |
"ROR" |
https://ror.org/05kb8h459 |
Funders
Funder type
Other
The Swedish Association for Cancer and Traffic Victims (Sweden)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2009 | Yes | No | |
| Results article | results | 11/06/2009 | Yes | No |
