Clinical trial NCT04746157: A Nursing Support Intervention-based Project for Stroke Survivors
Official title: A Nursing Support Intervention-based Project for Stroke Survivors to Improve Patient Centered Outcomes Measures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
ICHOM
PROMS
patient reported outcome measures
nursing support intervention-based project
nurse
DALYs
Lead sponsor: Institut de Recerca Biomèdica de Lleida
Sponsor class: OTHER
First posted: 2021-02-09
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in PROMIS
timeFrame: Baseline, 90 ±7 days and 365 ±7 days post-stroke
measure: Change from baseline in quality of life measured in EQ-5D-5L
timeFrame: Baseline, 90 ±7 days and 365 ±7 days post-stroke
measure: Change from baseline in the risk for stroke recurrence measured by 3. Riskometer score
timeFrame: Baseline, 90 ±7 days and 365 ±7 days post-stroke
Secondary outcomes:
measure: Controlled blood pressure
timeFrame: 12 months
measure: Controlled LDL levels
timeFrame: 12 months
measure: Medication adherence
timeFrame: 12 months
measure: Adherence to Mediterranean diet
timeFrame: 12 months
measure: Biometric data
timeFrame: 12 months
measure: Stroke recurrence
timeFrame: 12 months
Other outcomes:
Locations:
city: Lleida
country: Spain
facility: IRBLleida
Study officials:
References:
citation: 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.