Self-management Program for Patients in the Sub-acute Phase After Traumatic Injury - a Feasibility Study

NCT06093074 | Completed

• 1 other identifier: msrasmussen
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• 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.

Conditions

Self-management; Feasibility Studies; Spinal Cord Injuries; Brain Injuries

Keywords

traumatic injuries; multi trauma; interventions

Outcome Measures

Primary Outcomes (3)

• Consent rate of eligible

  Recruitment procedures will be assessed by consent rate. Highly feasible: More than 75-100 % consent rate Moderately feasible: 50-74% consent rate Not feasible: Less than 50% consent rate

  Will be evaluated after the intervention period, i.e. 2-3 months after inclusion

• Drop-out rate

  Recruitment procedures will be assessed by drop-out rate. Highly feasible: Less than 25% drop-outs Moderately feasible: 35-26% drop-outs Not feasible: More than 35% drop-outs

  Will be evaluated after the intervention period, i.e. 2-3 months after inclusion

• Attendance rate

  Acceptability for participants will be assessed by percentage of sessions attended. Highly feasible: 90% or more attendance Moderately feasible: 75%-89% attendance Not feasible: Less than 75% attendance

  Will be evaluated after the intervention period, i.e. 2-3 months after inclusion

Secondary Outcomes (3)

• Patient acceptability and receipt

  Will be evaluated after the intervention period, i.e. 2-3 months after inclusion

• Usefulness of intervention rated by participants

  Will be evaluated after the intervention period, i.e. 2-3 months after inclusion

• Recommendation to others

  Will be evaluated after the intervention period, i.e. 2-3 months after inclusion

Other Outcomes (5)

• Fidelity of therapists' adherence

  Will be evaluated after the intervention period, i.e. 2-3 months after inclusion

• Protocol adherence by study-specific checklists.

  Will be evaluated after the intervention period, i.e. 2-3 months after inclusion

• Feasibility of telehealth intervention by technical log over reported technical failures (by therapist).

  Will be evaluated after the intervention period, i.e. 2-3 months after inclusion

Study Arms (1)

intervention group

EXPERIMENTAL

Feasibility trial study group.

Behavioral: self-management program after traumatic injuries

Interventions

self-management program after traumatic injuries BEHAVIORAL

The self-management support (SMS) program is manualized and will include eight weekly 2.5-hour sessions in groups of 5-7 participants. This feasibility trial will assess both face-to-face delivered program and a tele-health program via electronic devices. The tele-health intervention will be delivered with the same SMS content, frequency, and in-group mode.

intervention group

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Cognitive function corresponding to a Mini Mental Status score \<20 points
• Severe psychiatric diseases or drug/alcohol dependence that require treatment
• Complete spinal cord injury or isolated abdominal/thoracic injuries
• Insufficient command of Norwegian.

Sponsors & Collaborators

• Oslo University Hospital: lead
• Sunnaas Rehabilitation Hospital: collaborator
• South-Eastern Norway Regional Health Authority: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, Norway

Location

Related Publications (9)

• Bonatti H, Calland JF. Trauma. Emerg Med Clin North Am. 2008 Aug;26(3):625-48, vii. doi: 10.1016/j.emc.2008.05.001.

  PMID: 18655938 BACKGROUND

• Gabbe BJ, Simpson PM, Cameron PA, Ponsford J, Lyons RA, Collie A, Fitzgerald M, Judson R, Teague WJ, Braaf S, Nunn A, Ameratunga S, Harrison JE. Long-term health status and trajectories of seriously injured patients: A population-based longitudinal study. PLoS Med. 2017 Jul 5;14(7):e1002322. doi: 10.1371/journal.pmed.1002322. eCollection 2017 Jul.

  PMID: 28678814 BACKGROUND

• Geraerds AJLM, Richardson A, Haagsma J, Derrett S, Polinder S. A systematic review of studies measuring health-related quality of life of general injury populations: update 2010-2018. Health Qual Life Outcomes. 2020 May 29;18(1):160. doi: 10.1186/s12955-020-01412-1.

  PMID: 32471430 BACKGROUND

• Huang S, Dipnall JF, Gabbe BJ, Giummarra MJ. Pain and mental health symptom patterns and treatment trajectories following road trauma: a registry-based cohort study. Disabil Rehabil. 2022 Dec;44(25):8029-8041. doi: 10.1080/09638288.2021.2008526. Epub 2021 Dec 6.

  PMID: 34871122 BACKGROUND

• World Health Organization. Rehabilitation 2030 Initiative. 2017 [cited 2022 29.07.22]; Available from: https://www.who.int/initiatives/rehabilitation-2030.

  BACKGROUND

• Lorig KR, Holman H. Self-management education: history, definition, outcomes, and mechanisms. Ann Behav Med. 2003 Aug;26(1):1-7. doi: 10.1207/S15324796ABM2601_01.

  PMID: 12867348 BACKGROUND

• Sohlberg, M.M., Cognitive Rehabilitation Manual: Translating Evidence-Based Recommendations into Practice. Archives of clinical neuropsychology, 2012. 27(8): p. 931-932.

  BACKGROUND

• Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M; Medical Research Council Guidance. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008 Sep 29;337:a1655. doi: 10.1136/bmj.a1655.

  PMID: 18824488 BACKGROUND

• Benight CC, Shoji K, James LE, Waldrep EE, Delahanty DL, Cieslak R. Trauma Coping Self-Efficacy: A Context-Specific Self-Efficacy Measure for Traumatic Stress. Psychol Trauma. 2015 Nov;7(6):591-599. doi: 10.1037/tra0000045.

  PMID: 26524542 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries; Brain Injuries; Wounds and Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Brain Diseases; Craniocerebral Trauma

Study Officials

• Nada Andelic, Phd

  Oslo University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a feasibility trial evaluating the feasibility and acceptability of a planned randomized controlled trial. Therefore, no control group will be included in this feasibility study.

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 23, 2023
• Study Start: October 16, 2023
• Primary Completion: February 20, 2024
• Study Completion: May 27, 2024
• Last Updated: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)