A Nursing Support Intervention-based Project for Stroke Survivors (PROICTUS)

March 13, 2024 updated by: Francisco Purroy, Institut de Recerca Biomèdica de Lleida

A Nursing Support Intervention-based Project for Stroke Survivors to Improve Patient Centered Outcomes Measures

Stroke is the second single most common cause of death and the main cause of disability in the European Union (EU) region. Stroke victims face an uncertain future and a life severely affected by disability. Although there have been many advances in scientific knowledge and innovation in stroke research, improvements in stroke systems of care are still necessary to ensure patient outcomes and improve their quality of life after stroke. The main goal of PROICTUS program ("pro" in Greek means before and in Latin means forward movement) is to evaluate a nursing support intervention to improve PROMS (patient reported outcome measures) and the quality of life in stroke survivors. Patients will have a directly contact with the lead nurse by telephone, so they will receive information about their disease, their current situation given them a personalized care and resolving questions that are important for them in their new life situation

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

It is estimated that 6 months after stroke, 45% of survivors have some type of functional dependence. The impact of stroke is quantified in disability adjusted life-years (DALYs), where DALY is 1 year of healthy life lost. Worldwide, the average number of post stroke DALYs is projected to be 60.9 million by 2030. Although, the incidence of stroke disease increases with age, rates in young adults are rising suggesting a need for strategies to improve prevention. Beyond vital prognosis, stroke patients are also at increased risk of poor outcome within the first year of the event including re-hospitalization, recurrent event, dementia, mild cognitive disorder, depression and fatigue, and all affect quality of life. Given these observations, an urgent development of acute care provision, as well as resources for post-stroke therapeutic strategies are needed. PROICTUS not only could improve PROMS (patient reported outcome measures) and quality of life, it is also the tool to increase the adherence to the treatment, reduce the risk factors and ensure an adequate secondary prevention. Patients will be recruited from the emergency service of the Hospital in a period within 14 days from the index event. Half of the selected participants will be part of the PROICTUS interventional project and the other half of the selected patients will receive the usual management. All patients will be contacted by a phone call, the PROICTUS project will be explained to both arms, inform consent obtained and a blood extraction (lipid profile and glycosylated haemoglobin) will be performed. Non interventional group will follow up usual medical care and they will not be contacted by the referent nurse for 12 months. After 1 year of the stroke, participants of the no intervention group will be contacted by phone and primary outcome measurements obtained.

Interventional group will receive a second call 30 days after the stroke. In the second call, patients will get personalize information about his/her health situation and comprehensive individualized communication. For that, the main intervention will be direct contact with the lead nurse by telephone/email.

Basal evaluation will be assessed by five surveys: PROMIS 57 Profile v.2.1, the EQ-5D-5L, survey of treatment adherence, survey of adherence to the Mediterranean diet and the Stroke Riskometer. These evaluation will be repeated at 90 days and 12 months after stroke. This group will also have a tensiometer to measure pressure blood, cardiac rate and detected arrhythmias. Additionaly, participants of this arm could call the nurse two days per week to ask her whatever they need.

Acute ischemic stroke represents a very important and still to be solved health and social problem. For that, this project is a great challenge and many people would beneficiate of its progress.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Lleida, Spain, 25198
        • IRBLleida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Ischaemic stroke or haemorrhagic stroke and NIHSS ≤ 5
  • TIA with motor, speech or visual impairment
  • Premorbid mRS<4
  • Event onset later than 72hr but within 14 days
  • Medically-stable
  • Consent-capable

Exclusion Criteria:

  • Advanced medical comorbidity (eg. dementia affecting basic activities of daily living, cancer, HIV, Hep B or C)
  • Isolated sensory symptoms
  • Aphasia
  • Cognitive impairment
  • Hearing loss
  • Taking part in another study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Usual care
Experimental: Intervention group
Patients will have a directly contact with the lead nurse by telephone during the study. The referent nurse will provide support and will promote engagement of patient to adequate secondary prevention measures. In addition, she will provide education based on stroke risk and identified vascular risk factors by Stroke Riskometer.
Other: Nurse intervention
Patients will undergo an individualized patient care plan conducted by a lead nurse. According to their results on the Stroke Riskometer and their cardiovascular risk factors, the nurse will prepare a phone call for the next two weeks with information and support adapted to each patient and their necessities. Phone calls will be repeated monthly until the sixth month, then, one more the ninth month and one last previous to the end of the treatment. Patients will be able to contact the reference nurse whenever they would need to.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline in PROMIS
Time Frame: Baseline, 90 ±7 days and 365 ±7 days post-stroke
PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health. It evaluates the following items: physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference and pain intensity.
Baseline, 90 ±7 days and 365 ±7 days post-stroke
Change from baseline in quality of life measured in EQ-5D-5L
Time Frame: Baseline, 90 ±7 days and 365 ±7 days post-stroke
The EQ-5D-5L is a standardised measure of health status. It describes five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has five response levels: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. At the end of the instrument there is a visual analogue scale (EQ VAS) that records the respondent's overall current health where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The EQ VAS provides a quantitative measure of the patient's perception of their overall health
Baseline, 90 ±7 days and 365 ±7 days post-stroke
Change from baseline in the risk for stroke recurrence measured by 3. Riskometer score
Time Frame: Baseline, 90 ±7 days and 365 ±7 days post-stroke

Riskometer is a tool for assessing the individual risk of a stroke in the next five or ten years.

It also provides information of what patients can do to reduce the risk.
Baseline, 90 ±7 days and 365 ±7 days post-stroke

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Controlled LDL levels
Time Frame: 12 months
Rate of patients with controlled LDL-c (levels <100 mg/dl)
12 months
Stroke recurrence
Time Frame: 12 months
Rate of patients with stroke recurrence
12 months
Controlled blood pressure
Time Frame: 12 months
Rate of patients with controlled blood pressure values (Systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg)
12 months
Medication adherence
Time Frame: 12 months
Rate of patients with medication adherence
12 months
Adherence to Mediterranean diet
Time Frame: 12 months
Rate of adherence to Mediterranean diet
12 months
Biometric data
Time Frame: 12 months
Rate of patients with body mass index <25
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut de Recerca Biomèdica de Lleida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CEIC-2171

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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