Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04117854 |
| Other study ID # |
SINpedSCI2018 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2018 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
November 2020 |
| Source |
Sunnaas Rehabilitation Hospital |
| Contact |
Wiebke Höfers, PhD student |
| Phone |
+46 96869346 |
| Email |
wiehof[@]sunnaas.no |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
INTRODUCTION: Due to the low incidence of pediatric spinal cord injury (SCI) and the high
demand for knowledge and research, international cooperation is needed to build a solid and
shared understanding of the extent of the problem, and also uniformity in treatment and
measurement methods. The aim of the study is to map organization of care and rehabilitation
of children and adolescents < 18 years of age with SCI, to explore qualitatively psychosocial
aspects of individuals and to establish use of common outcome measures in 10 rehabilitation
units from seven countries, cooperating within the Sunnaas International Network in
Rehabilitation (SIN); China, USA, Russia, Israel, Palestine, Norway and Sweden.
METHOD: In Phase I two cross-sectional studies will be conducted to set the scene for the
outcome studies following in Phase II (2020-2022). Phase I consists of a quantitative
descriptive study using a websurvey to describe and compare the systems of care and delivery
of inpatient rehabilitation services for pediatric SCI patients. In addition, a qualitative
study will explore the psychosocial aspects of living with a childhood acquired SCI. Two
adolescents, aged 13-17 years and at least 6 months post-acute treatment, from each unit will
interviewed using a semi-structured interview guide. Ethical approval has been applied for in
each unit, and the study is registered at ClinicalTrial-gov. A workshop for the 24 study team
members, where the main focus was to ensure that data collection is conducted in a good
manner, was held in May 2018, and data collection is expected finalized by 2020. Phase II
(planning stage) will consist of methodological outcome studies.
DISCUSSION: Phase I of the study will broaden the body of knowledge on pediatric SCI
internationally, thus enabling comparison, discussion and development of organizational
models and quality of care and rehabilitation for young persons with SCI. Phase II will
contribute to the use of common and reliable outcome measures for these patients.
Description:
INTRODUCTION Spinal cord injury (SCI) before the age of 15 is rare affecting less than 1 in
every 100 000 children. Over the past decade the management of pediatric spinal cord injury
and the long-term outcomes have received increased attention, however, most research has its
origin from the US. Thus, there is a need for more knowledge about occurrence and causes,
functional recovery, activity, participation and quality of life in children and adolescents
in other countries than the US. Moreover, a systematic review 2011 shows that there is
limited evidence about the effectiveness of interventions for the management of children with
SCI.
Knowledge regarding organization of care and rehabilitation is incomplete and differences
between countries are substantial. Also, comparisons of data between countries and studies
have been problematic due to differences in case definitions and age limits as to what is
considered pediatric as opposed to adult SCI. Therefore, there is a need for international
collaboration and research within the area of pediatric SCI with uniformity in methodology in
the gathering of information and publication of the data to compare results between
countries.
Due to the low incidence of pediatric SCI and the demand for more knowledge and research,
international cooperation is needed for purposes of building a solid and common understanding
of the scope of the problem and uniformity in management and methodology.
To reach this goal in the SIN context there is a need to benchmark between units, to
highlight opportunities to improve systems of care and service delivery and to provide an
understanding of the context of the units and the similarities and differences between them
as this will be important for interpreting the results from subsequent phases of this project
when patient outcomes are reported.
Exploration of psycho-social issues from the perspective of the affected young persons and
their families will assist targeting issues that are clinically and socially relevant for
future service and future research cooperation. In addition, to be able to gather information
to compare results between countries it is important to establish use of common outcome
measures.
AIMS AND OBJECTIVES Long term aim and objective The long-term goal of this research project
is to optimize organization, care and rehabilitation in Norway and cooperating rehabilitation
units internationally, to increase the awareness of subjective perceptions and psychosocial
aspect of young persons with spinal cord injury, and to establish the use of outcome measures
in local languages. Participants will be recruited from the rehabilitation hospitals
cooperating within the Sunnaas International Network for Rehabilitation; Norway, Sweden,
China, Russia, US, Israel, Palestine (SIN-units).
Specific aims and objectives
- To survey the SIN units in order to describe and compare the organization and delivery
of inpatient rehabilitation services and systems of care for pediatric SCI patients
- To explore qualitatively psychosocial aspects of living with spinal cord injury in
children and adolescents in SIN units using individual, semi-structured interviews
MATERIAL AND METHODS Study design This project is a cross sectional international multicenter
study. A PhD-student is associated with the study (Oslo Metropolitan University/ Sunnaas
Rehabilitation Hospital, start September 2019).
The first stage of the project (Phase I) will comprise a descriptive part (Study I, Web
survey) and an explorative part (Study II, semi-structured interviews) conducted in clinical
settings in Norway, Sweden, China, Russia, US, Israel and Palestine.
Recruitment The recruitment will be done within the units cooperating in the Sunnaas
International Network for Rehabilitation (SIN).
The local principle investigator in each unit will be responsible for collecting data in
Study I and recruiting individuals to participate in Study II of the study. Potentially
eligible individuals with SCI will be identified from the departmental or institutional
database. If no suitable database is present in an investigative site, recruitment through
alternative databases will be explored and discussed with project collaborators.
Once identified, the study coordinator and local investigator will agree participant
identification codes for the selected individuals. The study coordinator will allocate a
three letter code (the first two letters will originate from the country of the study site,
and the third from the name of the institution).
Inclusion criteria´s for the target group
- Children and adolescents (< 18 years)
- Diagnoses: either a non-traumatic or traumatic SCI after the age of 7
- Has been discharged from initial rehabilitation for 6 months or more
General Exclusion Criteria
• Diagnosis of severe neurological conditions affecting the cognition of the child or
adolescent (e.g. as a result of encephalocele or acquired brain injury)
Participants Study I (descriptive study/ web survey). Ten rehabilitation units in Norway,
Sweden, China, Russia, US, Israel and Palestine will be participating. The local principle
investigator in each unit will be responsible for data collection.
Study II (explorative study/semi-structured interviews). Two individuals in each of the ten
SIN units, fulfilling the inclusion criteria's, will be recruited. A maximum of 20 young
informants 13-17 years will be interviewed and constitute the study group of the
International qualitative study. In addition, all norwegian youth with SCI rehabilitated at
Sunnaas Rehabilitation Hospital fulfilling the inclusion criteria and beeing13-17 years of
age during the inclusion period, will be recruited and constitute the study group of the
Norwegian qualitative study (6-10 persons). Pilot interviews will be conducted prior to data
collection.
Data collection and analyzing Study I (descriptive study/ web survey) A web-survey based on
clinical expertise and literature review have been developed in cooperation between Dr Peter
W New, Spinal Rehabilitation Service, Caulfield Hospital, Australia and Norwegian clinicians
and researchers with experience in pediatric SCI. The survey is a development and an adapted
version of the survey used to conduct an international comparison of the organization of
rehabilitation services and systems of care for adult patients with non-traumatic SCI in
Italy, Ireland, India, Pakistan, Switzerland, the Netherlands, US, Australia and Canada.
The survey will be used to gather descriptive data to review the various forms of care and
rehabilitation services available to children and adolescents with SCI in SIN unit catchment
areas. In addition, telephone or Skype-interviews will be used to complement data when
necessary.
The following main issues will be explored (detailed questionnaire is available):
I. Hospital setting, interaction with acute hospitals and referral processes II.
Rehabilitation beds and patient case-mix III. Spinal rehabilitation and staffing and therapy
intensity IV. Availability of secondary staff, ancillary services and support V. Life long
follow-up
Also, the following background information will be collected:
1. SCI-prevention programmes in the region
2. Brief review of the implementation of child protection in each region
The questionnaire will be available both electronically and in a paper version in English and
will be completed by the local principal investigator (PI) or by a representative from each
of the participating units chosen by the local PI. The local PI will be a bilingual person
with good local knowledge. Clarification of responses will occur in cooperation between the
local PI and the project manager at Sunnaas. Descriptive analysis will be performed with the
median and interquartile range (IQR) reported for numerical data not normally distributed.
Study II (explorative study/ interviews) An inductive, exploratory study with a qualitative
design will be chosen to obtain a detailed description and understanding of how children aged
of 13-17 years, perceive living with SCI in SIN-unit catchment areas.
Individual, face-to-face interviews will be conducted based on a thematic, semi-structured
interview guide with relevant follow-up questions. The interviews will take place in the
informant's home or another place chosen by the informant. Ninety minutes or more will be
allowed for each interview. Due to Corona restrictions virual interviews on a safe digital
platform like Teams or Norske Helsenett will be allowed. This apply especially for the
additional Norwegian interviews as they are planned to take place during the autumn of 2020
and spring of 2021.
A semi-structured interview guide has been developed in cooperation between researchers and
clinicians with experience in working with children and adolescents. Appropriate open ended
questions are listed within each main area of the interview and key-questions are marked to
assure that they are asked for. A salutogenic approach with strength based questions built on
established principles and guidelines for psychosocial screening in young persons has been
used (EuTEACH; HEEADSSS assessment; HEADSSS assessment, Clinical Practice Guidelines).
Themes in the semi-structured interview guide (detailed interview guide is available):
- The injury/ the accident
- Acute care, rehabilitation and follow-up
- Daily living with SCI with a pediatric onset
- Home, education/employment, eating, activities, drugs, sexuality,
suicide/depression/self-image, safety (HEEADSSS)
- Resources and networks
- Health
- Peer learning/ role models
- The future/ life goals
Pilot interviews will be conducted to test the interview guide before deciding on a final
version that will be translated to all relevant languages.
To assure that all interviews are conducted in a good manner in different units, an
educational curriculum will be developed. Also, the interviewers will be trained in a 2-day
seminar. All interviews will be taped with a digital voice recorder and transcribed verbatim
in each unit. The transcripts will be translated to Norwegian by bilingual translators with
knowledge of neurological rehabilitation and analyzed using inductive qualitative content
analysis seeking to identify both manifest categories and underlying, latent meanings.
ETHICAL CONSIDERATIONS Ethical approval will be applied for in each country (Norway, Sweden,
China, Russia, US, Israel and Palestine). All encoded material will be entered in a database
at the Department of Research, Sunnaas Rehabilitation Hospital. Passkey will be stored
separately and locked in a fireproof safe. Recorded/taped interviews will be transcribed and
encoded and both the audio file (also encoded) and the transcript will be stored in a locked,
fireproof safe.
Candidate participants will be approached and informed about the study by a letter. The
letter will explain (1) the purpose of the study, (2) the procedures and (3) confidentiality.
The participant will be informed about their right to withdraw at any time and for any reason
without affecting your treatment by any means. The letter will include an 'Informed Consent
Form' that he/she and his/her caregivers must sign and date and return to their study site
before they can participate.
