Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06153017 |
| Other study ID # |
iTMS786101 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2023 |
| Est. completion date |
September 30, 2025 |
Study information
| Verified date |
November 2023 |
| Source |
University of Aarhus |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Reliable prediction of upper limb (UL) function can guide clinicians in choosing relevant
treatment, helps to set realistic goals for rehabilitation and will contribute to
personalized and effective rehabilitation. TMS has been identified as a strong predictor of
future UL function after stroke. With this project, the investigators want to implement the
standard use of TMS examination for a defined patient group in the clinical setting and
systematically evaluate the implementation process. The impact and perceived value of TMS in
the clinical setting will be evaluated and the predictive value of TMS for the specific
patient population will be assessed.
Description:
Design Design: A prospective longitudinal implementation study. Setting and population: The
implementation will take place at Hammel Neurorehabilitation Centre and University Research
Clinic. The target population are patients with stroke.
Management The study will be organized by the Research Unit at Hammel Neurocenter, Iris
Brunner, associate professor, PhD, in collaboration with the Center Management represented by
head physician Kåre Eg Severinsen, MD, PhD and the unit for professional development,
represented by Camilla Biering Lundquist PhD.
Evaluation of the implementation The RE-AIM framework, and its extension, the Practical
Implementation Sustainability Model (PRISM) framework will be applied to guide and evaluate
the implementation process. The RE-AIM framework has been used in numerous studies and hosts
a homepage with comprehensive online resources for planning, evaluating and reporting
implementation studies.
Briefly, it consists of the following components to evaluate the success of an
implementation:
Reach. Refers to percent of individuals who are reached by the intervention. In the context
of the present study, Reach would describe the number of patients for whom the TMS
examination would be relevant, and the percentage of patients who received TMS, and reasons
for not being examined.
- Evaluation of Reach through monitoring of 4 selected wards with the help of the Business
Intelligence (BI) portal.
Effectiveness: Entails the measurement of primary and broader outcomes. In this study,
Effectiveness would assess the prediction accuracy for the specific population at the
hospital.
- Evaluation of Effectiveness. Fifty patients will be recruited consecutively from all wards
at Hammel Neurorehabilitation Center's sites Hammel and Skive. Follow-up assessments of UL
function will be conducted at 3 months post-stroke with the tests of UL function described in
3d. It will be assessed if individual predictions based on TMS and clinical tests will reach
a specificity of 80% or more. In addition, sensitivity, PPV, NPV and overall accuracy/ CCP
including 95% CI will be calculated.
Adoption. The level of actual uptake of the new intervention. Specifically in this study the
number of referrals of relevant patients from different wards. Moreover, the number of
involved staff (therapists, MDs) with a positive attitude to the TMS examination.
- Evaluation of adoption will based on quantitative data from monitoring, questionnaires, and
interviews.
Implementation. Description of the actual resources and cost allocated, intervention
fidelity, and acceptance.
- Implementation is evaluated with regard to intervention fidelity. In this case, can
patients be examined with TMS within the planned time after stroke and is the workload for
trained examiners distributed as agreed on.
Maintenance. Measures the long-term attrition to an intervention on an individual and a
setting level.
- Among others, the following questions will be addressed: Are the potential obstacles
identified in previous components of reach addressed? Is the rate of patients referred to TMS
stable over time? Can examination skills be maintained or is there need for a boost? Has new
staff been introduced to perform the TMS procedure? Based on these questions and the feedback
from questionnaires and interviews the investigators will continuously respond to threats to
maintenance and adapt maintenance strategies accordingly.
