Self-management Program for Patients in the Sub-acute Phase After Traumatic Injury - a Feasibility Study
Key facts
- Who runs it
- Oslo University Hospital
- Where
- Norway1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 11 people enrolled
- Started
- 16 Oct 2023
- Ended
- 27 May 2024
- Type of study
- Interventional
- Treatments tested
- self-management program after traumatic injuries
- Record updated
- 30 May 2024
Who can take part
- Age
- 18 years to 72 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- Adults between 18-72 years residing in the southeast region of Norway
- Admitted to OUH directly or after transfer from local hospitals within 72 hours of injury
- At least a two-day hospital stay
- Traumatic injury corresponding to a New Injury Severity Scale score (NISS) >9
- Patients reporting injury-related symptoms, functional impairments, and/or difficulties with daily activities at discharge from Oslo University Hospital
- Time since injury 3-4 months post-injury at inclusion
Who cannot take part
- Severe psychiatric diseases or drug/alcohol dependence that require treatment
- Cognitive function corresponding to a Mini Mental Status score <20 points
- Complete spinal cord injury or isolated abdominal/thoracic injuries
- Insufficient command of Norwegian
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
The goal of this descriptive non-randomized feasibility study is to assess aspects of feasibility of the intervention arm in a planned full-scale randomized controlled trial testing the effectiveness of a self-management program for persons who have sustained a moderate to severe traumatic injury. All outcomes will be evaluated based on pre-defined success criteria. The main outcomes in the feasibility study are:
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* Consent rate of eligible patients * Drop-out rate * Attendance rate in the program sessions
Secondary outcomes are the participants' acceptance, reception, and perceived usefulness. Other outcomes are fidelity and protocol adherence, as well as the feasibility of a telehealth version of the program and the data collection methods.
The participants will receive a group-based self-management program consisting of eight weekly 2.5-hour sessions delivered by a multidisciplinary team. The self-management program is manualized and includes psychoeducation, training in self-management skills and strategies, setting goals, action planning, and sharing of experiences. The participants will also complete the pre- and post-intervention assessments.
The group in the trial
- intervention groupTreatment being tested
Feasibility trial study group.
Treatment: self-management program after traumatic injuries
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Self-management Program for Patients in the Sub-acute Phase After Moderate to Severe Traumatic Injury -a Feasibility Study
- Record updated
- 30 May 2024