A Nursing Support Intervention-based Project for Stroke Survivors

NCT04746157 | Completed

• 1 other identifier: CEIC-2171
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stroke

Keywords

Stroke; ICHOM; PROMS; patient reported outcome measures; nursing support intervention-based project; nurse; DALYs

Outcome Measures

Primary Outcomes (3)

• Change from baseline in PROMIS

  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

  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

  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 Outcomes (6)

• Controlled blood pressure

  12 months

• Controlled LDL levels

  12 months

• Medication adherence

  12 months

• Adherence to Mediterranean diet

  12 months

• Biometric data

  12 months

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Usual care

NO INTERVENTION

Usual care

Interventions

Nurse intervention OTHER

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.

Intervention group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut de Recerca Biomèdica de Lleida: lead

Study Sites (1)

IRBLleida

Lleida, 25198, Spain

Location

Related Publications (1)

• Parmar P, Krishnamurthi R, Ikram MA, Hofman A, Mirza SS, Varakin Y, Kravchenko M, Piradov M, Thrift AG, Norrving B, Wang W, Mandal DK, Barker-Collo S, Sahathevan R, Davis S, Saposnik G, Kivipelto M, Sindi S, Bornstein NM, Giroud M, Bejot Y, Brainin M, Poulton R, Narayan KM, Correia M, Freire A, Kokubo Y, Wiebers D, Mensah G, BinDhim NF, Barber PA, Pandian JD, Hankey GJ, Mehndiratta MM, Azhagammal S, Ibrahim NM, Abbott M, Rush E, Hume P, Hussein T, Bhattacharjee R, Purohit M, Feigin VL; Stroke RiskometerTM Collaboration Writing Group. The Stroke Riskometer(TM) App: validation of a data collection tool and stroke risk predictor. Int J Stroke. 2015 Feb;10(2):231-44. doi: 10.1111/ijs.12411. Epub 2014 Dec 10.

  PMID: 25491651 RESULT

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: February 9, 2021
• Study Start: March 15, 2021
• Primary Completion: December 31, 2023
• Study Completion: March 1, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

ES (1)