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

NCT06093074 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2024-05-30

No results posted yet for this study

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

Interventions

BEHAVIORAL

self-management program after traumatic injuries

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.

Sponsors & Collaborators

  • Sunnaas Rehabilitation Hospital

    collaborator OTHER

  • South-Eastern Norway Regional Health Authority

    collaborator OTHER

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Nada Andelic, Phd · Oslo University Hospital

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
72 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-16
Primary Completion
2024-02-20
Completion
2024-05-27

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06093074 on ClinicalTrials.gov