Multiple Interventions to Accelerate the Return to the Pre-event Level of Functioning After a TIA… (NCT05369637) | Clinical Trial Compass
UnknownNot Applicable
Multiple Interventions to Accelerate the Return to the Pre-event Level of Functioning After a TIA and Minor Stroke
Portugal70 participantsStarted 2022-05-11
Plain-language summary
The occurrence of a transient ischemic attack (TIA) or a minor stroke is frequently assumed as a temporary and non-disabling event. Nevertheless, patients can experience subtle but meaningful impairments, including a decreased performance in activities of daily living (ADLs), a high prevalence of depression, cognitive decline, physical deficits, hearing degeneration, with implications in returning to work, social relations and activities. Additionally, it has been described a higher risk of stroke among these patients, which highlights the importance of promoting secondary prevention, soon after these acute episodes. Therefore, this pilot randomized controlled trial (RCT) aims to evaluate the feasibility and the effectiveness of a three-month multidomain intervention program, composed of five non-pharmacological components which may contribute to accelerate the return to the pre-event level of functioning in patients with TIA and minor stroke. The results may guide future clinical practices and health policies aiming to reduce the overall burden of stroke.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged 18-85 years old;
* Clinical diagnosis of transient ischemic stroke or minor stroke as defined by the National Institute of Health Stroke Scale score ≤3;
* Onset of symptoms within the last seven days;
* First-time stroke or TIA;
* Four or more years of education;
* Discharged home without the need for inpatient rehabilitation;
* Modified Rankin Scale 0 to 2, inclusive.
Exclusion Criteria:
* Unable to attend the face-to-face intervention sessions;
* Previous diagnosis of Dementia or severe disability;
* Contraindication for physical exercise;
* Severe loss of hearing, vision, or communication skills;
* Frailty, reduced life expectancy due to severe disease or need for regular treatments that compete with availability for intervention.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to recovery in each instrumental activity of daily living
Timeframe: 3 months
2
Recruitment timeframe
Timeframe: 3 months
3
Adherence to each component of the intervention
Timeframe: 3 months
4
Dropout
Timeframe: 3 months
Trial details
NCT IDNCT05369637
SponsorInstituto de Saude Publica da Universidade do Porto