Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05234528
Other study ID # F2022-019
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date February 1, 2022
Est. completion date March 1, 2025

Study information

Verified date May 2024
Source Aalborg University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Background: Transient ischemic attack (TIA) is defined as acute neurological symptoms of vascular origin, which resolves completely within 24 hours. However, emerging evidence indicates that up to 1/3 of patients is experiencing (non-focal) lasting symptoms, such as fatigue, depression, and anxiety. Aim: The aim of this study is to investigate self-reported lasting symptoms after TIA, timing of these symptoms as well as their potential resolution and characterize patients who have high risk for developing these symptoms. Method: This is a prospective cohort study which will include 350-400 patients with TIA from a single comprehensive stroke care center which serves the population in North Denmark Region, one of five administrative regions in Denmark (Stroke Unit, Aalborg University Hospital). Outcome measures include patient-reported outcomes collected at discharge, 3, 6 and 12 months and semi-structured interviews with a selected sample of patients. Perspective: This study will provide much needed insights into the development of lasting symptoms in patients with TIA in a cohort with presumed high external validity. Based on these results, a person-centered intervention will be designed to support the return to everyday life for patients with TIA.


Description:

Background: In Denmark approximately 4.000 patients every year are diagnosed with Transient Ischemic Attack (TIA). In Denmark the time-based definition of TIA is used and based on a clinical assessment with acute, often focal neurological symptoms of vascular origin resolving completely within 24 hours. Emerging evidence suggests however, that 1/3 of patients experience lasting symptoms as cognitive impairments, depression, anxiety and/or fatigue, which may impact their ability to return to their normal everyday life. Patients' own perception of a complex and life-altering experience has been identified in the qualitative literature. Some patients experiencing lasting symptoms and alterations in multiple life domains like a feeling of uncertainty, vulnerability, instability and change. According to this review, some patients reported that physical and psychosocial symptoms were not recognized, nor acknowledged by their healthcare professionals. Education for clinicians was recommend to enable them to understand these difficulties, improve interaction and meet the patients' needs. It is unknown which patients are at increased risk of experiencing the described lasting symptoms when these symptoms arise and how it affects quality of life and return to everyday life. Answers to these questions will allow the design and test of an evidence-based and patient-centered intervention. The ultimate goal will be the creation of an evidence-based guide on how to follow-up and intervene in patients with TIA to ensure the return to their everyday life. Aim: The aim of this study is to investigate self-reported lasting symptoms after TIA, timing of these symptoms as well as their potential resolution and characterize patients who have high risk for developing these symptoms. Furthermore, the socio-economic consequences of TIA will be investigated. Methods: The study is designed as a prospective cohort study using mixed methods. As used in the clinical settings in Denmark the time-based definition of TIA will be applied in this study. The diagnosis is defined by acute focal neurological symptoms of vascular origin resolving completely within 24 hours, thereby allowing acute ischemia on imaging. Recruitment: All patients diagnosed with TIA from the Stroke Unit, Aalborg University Hospital will be screened for eligibility. Inclusion will follow a twostep approach; 1) using clinical and demographic information from medical records, 2) receiving questionnaires at baseline, 3, 6 and 12 months follow-up. Baseline characteristics and potential prognostic factors: A pre-TIA modified Rankin Score (mRS) will be collected to describe the pre-TIA level of function for the included patients. To investigate which patients are at increased risk of experiencing the lasting symptoms multiple potential prognostic factors will be registered at inclusion. In addition to age and gender these include the following - Alcohol consumption (<7, 7-14 or >14 units/week) and/or use of narcotics on a weekly basis - Smoking - Housing (living in own home, nursing home or other) - Civil status (living alone, cohabitant (with partner, children, other)) - Cardiovascular risk factors as registered in the Danish Stroke Registry - Comorbidities in form of other chronic diseases (these will be categorized in neurodegenerative, psychiatric, other) - Previous stroke - Previous TIA - Previous diagnosis or use of medication for depression and/or anxiety - Previous use of antihypertensive, antiplatelet, oral anticoagulation, statins, antidiabetics - Acute infarction on imaging - Highest finished education and corresponding ISCED level. - Employment status (employed >30 hours/week, employed <30 hours/week, unemployed, retired, other) - ABCD2 stroke risk stratification. All interventions initiated after discharge based on the TIA will also be registered. The diagnosis of TIA in clinical settings is challenging. Therefore, after inclusion of patients the diagnosis of TIA will be verified independently by two stroke neurologists. Disagreement will be resolved by a third senior stroke neurologist. This verification will categorize patients in per protocol confirmed TIA versus non-confirmed TIA allowing for a subgroup analysis of outcome according to this categorization. The verification will be guided by the calculation of The Recognition of Stroke in the Emergency Room (ROSIER) score. Considerations on sample size: In the last 5 years, the incidence of TIA registered at the Stroke Unit, Aalborg University Hospital ranged from 369 to 463 patients per year. The content of the project is both to explore non-focal lasting symptoms in patients with TIA as well as prognostic factors, which has not been done previously to this extend. Thus, a specific sample size calculation is therefore not feasible as to many factors are unclear. Based on the average annual admission rate the goal is to include 350-400 patients. There is a time constraint of inclusion for a total of 12 months. This sample-size is deemed sufficient to be able to describe the self-report outcomes across 12 months and provide preliminary data on the proportion of patients in high risk of a poor prognosis. Data management and statistical analysis: Data will be handled in REDCap and analyzed in STATA. Baseline descriptive data will be presented as medians and interquartile ranges or frequencies and percentages where appropriate. Missing data will be handled with multiple imputation with chained equations to impute the missing data. To investigate the development of the included outcomes over time (baseline, 3 months, 6 months and 12 months) a longitudinal regression model will be used. For the primary effect measure, we will implement linear regression, while for supplementary effect measures we will use ordered logistic regression. Because of the repeated measures design the model will be a mixed effects model with a random intercept and fixed treatment variables. After discharge each patient can receive different follow-up and treatment interventions and the implementation of these varies over time. For the primary analysis patients will be assigned to each of the two main treatment tracks at baseline. An additional time-varying variable which indicates the progress of the two treatment tracks categorized as "no further treatment" or "further treatment" will be included in the model. For the subsequent treatment categories, we will conduct similar secondary analyses, but stratified by main treatment arm. For all analyses, the model will include time dependent covariates, thus, potential prognostic factor and baseline characteristic adjustment will be conducted using Marginal Structure models. Study results will be presented with 95% confidence intervals (CI). To compare results with the existing literature, we will estimate mean and median outcomes with 95% CI for each of the follow-up timepoints The qualitative semi-structured interviews will be handled in NVivo. An explorative and inductive thematic analysis will be performed by two researchers.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 355
Est. completion date March 1, 2025
Est. primary completion date March 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosis of TIA (ICD-10 code DG45, except DG45.3 Amaurosis fugax and DG45.4 Global Transient Amnesia) and for a) accumulated TIA (>1 event within the last 30 days): contact to the healthcare system within 30 days from symptom onset, b) not-accumulated TIA: contact to the healthcare system within 7 days from symptom onset. (as defined in the Danish Stroke Registry) - Minimum 18 years of age - Availability for follow-up during the study period - Able to read and understand Danish - Able to fill out questionnaires (assessed by the associated healthcare professional) - Not included in any other research projects

Study Design


Locations

Country Name City State
Denmark Aalborg University Hospital Aalborg

Sponsors (2)

Lead Sponsor Collaborator
Aalborg University Hospital Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Presence of fatigue at 3 months Fatigue using the Multidimensional Fatigue Inventory 3 months after event
Secondary Presence of fatigue immediately and 3-, 6- and 12-months after discharge Fatigue Severity Scale 1-2 weeks, 3-, 6- and 12-months after discharge
Secondary Presence of fatigue immediately and 3-, 6- and 12-months after discharge Multidimensional Fatigue Inventory 1-2 weeks, 6- and 12-months after discharge
Secondary Presence of depression and anxiety immediately and 3-, 6- and 12-months after discharge Hospital Anxiety and Depression Scale 1-2 weeks, 3-, 6- and 12-months after discharge
Secondary Patients experience of their quality of life immediately and 3-, 6- and 12-months after discharge EQ-5D-5L 1-2 weeks, 3-, 6- and 12-months after discharge
Secondary Patients experience of well-being immediately and 3-, 6- and 12-months after discharge WHO-5 1-2 weeks, 3-, 6- and 12-months after discharge
Secondary Patients ability to manage everyday life and differences in pre- and post-TIA status immediately and 3-, 6- and 12-months after discharge The Stroke Specific Quality of Life (third section) 1-2 weeks, 3-, 6- and 12-months after discharge
Secondary Level of function immediately and 3-, 6- and 12-months after discharge Modified Rankin Scale 1-2 weeks, 3-, 6- and 12-months after discharge
Secondary The patients ability to obtain information and knowledge to maintain and improve health using questions on health literacy The European Health Literacy Survey Questionnaire, 12 items 1-2 weeks, 3-, 6- and 12-months after discharge
Secondary Patient experienced outcomes of lasting symptoms (if any) and how these affect everyday life Open question on patients own experience of lasting symptoms affecting everyday life 1-2 weeks, 3-, 6- and 12-months after discharge
Secondary Qualitative interviews To provide a deeper understanding of the experiences with and impact of TIA on everyday life Qualitative interviews will be performed with a sample of 15-20 patients. A purposeful sampling strategy will be used to include patients with different demographics and outcomes, to ensure rich and varied data. 4 months after discharge
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05559255 - Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI N/A
Completed NCT06238557 - Prospective Evaluation of Psychological Consequences and Impact on Long-term Quality of Life
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT05472935 - Asynchronous Mindfulness Based Stress Reduction to Reduce Burnout in Licensed Clinical Social Workers N/A
Recruiting NCT04444544 - Quality of Life and High-Risk Abdominal Cancer Surgery
Completed NCT04281953 - Impact on Quality of Life of Long-term Ototoxicity in Cancer Survivors
Recruiting NCT05546931 - Mobile Health Program for Rural Hypertension N/A
Active, not recruiting NCT04746664 - Effects of Nutrition Counselling on Old Age People's Nutritional Status and Quality of Life in Bahir Dar City, North West Ethiopia N/A
Completed NCT05387174 - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period N/A
Recruiting NCT04142827 - The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care in Patients With Bronchiectasis (BX) N/A
Active, not recruiting NCT05903638 - A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility N/A
Completed NCT05538455 - Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases N/A
Completed NCT06216015 - Exercise Training and Kidney Transplantation N/A
Completed NCT03813420 - Sleep Quality of Physiotherapy Students Quality of Life and Physical Activity Level N/A
Recruiting NCT05550545 - Infant RSV Infections and Health-related Quality of Life of Families
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Recruiting NCT05233020 - Robotic Versus Hybrid Assisted Ventral Hernia Repair N/A
Terminated NCT03304184 - The Role of Biodentine in Class V Dental Lesions on Oral Health Related Quality of Life Phase 3
Completed NCT05063305 - Probiotics, Immunity, Stress, and QofL N/A
Recruiting NCT05380856 - Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction N/A