NCT06264037

Brief Summary

In this exploratory qualitative study with a hermeneutic phenomenological approach, we will describe and understand the experience of treatment and hospitalization in hospitalized people suffering from stroke, multiple sclerosis, Parkinson\'s disease and patients post-neurosurgery for oncological causes. Patients will be interviewed in a semi-structured manner and sampling will take place for each of the pathology groups according to the saturation method.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 16, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2025

Completed
Last Updated

February 16, 2024

Status Verified

February 1, 2024

Enrollment Period

1.7 years

First QC Date

February 8, 2024

Last Update Submit

February 8, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • narrative contents

    the personal experience of hospital stay in neurorehabilitaion setting

    30- 40 minutes of interview

Study Arms (4)

Patients with stroke

Patients with stroke during the hospital neurorehabilitation

Other: semi structured interview

People with Parkinson's disease

patients with Parkinson's disease the hospital neurorehabilitation

Other: semi structured interview

Patients with multiple sclerosis

Patients with multiple sclerosis during the hospital neurorehabilitation

Other: semi structured interview

Patients post operative oncological neuro surgery

Patients after oncological neurosurgical operation during the hospital neurorehabilitation

Other: semi structured interview

Interventions

semistructured interview on patient\'s experience of hospitalization.

Patients post operative oncological neuro surgeryPatients with multiple sclerosisPatients with strokePeople with Parkinson's disease

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Stroke, Multiple Sclerosis, Parkinson\'s Disease and post-operative Neurosurgery patients admitted to the IRCCS San Camillo will be recruited.

You may qualify if:

  • patients in Stroke, Multiple Sclerosis, Parkinson\'s Disease and post-operative patients in Neurosurgery for oncological pathology
  • Patients who have given valid consent.
  • Patients able to understand, read and speak Italian.
  • Aphasic patients without comprehension deficits and able to communicate effectively with augmented communication media.
  • hospitalized for at least 21 days and not close to discharge, or that this occurs at least after 21 days.

You may not qualify if:

  • Minor patients or patients over 85 years of age.
  • Patients with cognitive deficits such that they cannot effectively support the interview.
  • Patients with psychiatric pathology
  • Patients unable to understand, read and speak Italian.
  • Patients with pathologies for which they are not undergoing neurorehabilitation treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Alberto Camuccio

Venezia, 30126, Italy

RECRUITING

IRCCS San Camillo Department of Neurorehabilitation, Venezia

Venezia, 30126, Italy

RECRUITING

IRCCS San Camillo Venezia

Venezia, 30126, Italy

RECRUITING

Related Publications (25)

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  • Canzan F, Saiani L, Mortari L, Ambrosi E. [When patients talk about healing: a phenomenological qualitative study]. Assist Inferm Ric. 2013 Oct-Dec;32(4):205-12. doi: 10.1702/1381.15358. Italian.

  • Chen Y, Zhou W, Hou L, Zhang X, Wang Q, Gu J, Zhang R, Yang H. The subjective experience of family caregivers of people living with Parkinson's disease: a meta-ethnography of qualitative literature. Aging Clin Exp Res. 2022 May;34(5):959-970. doi: 10.1007/s40520-021-01995-9. Epub 2021 Oct 14.

  • Fidder H, Jaski JJ, Elbertse E, van Loon AM, Monnier AA, de Boer ME, de Groot AJ. Parkinson rehabilitation in nursing homes: a qualitative exploration of the experiences of patients and caregivers. Eur Geriatr Med. 2022 Oct;13(5):1197-1210. doi: 10.1007/s41999-022-00647-z. Epub 2022 May 11.

  • Fleming V, Gaidys U, Robb Y. Hermeneutic research in nursing: developing a Gadamerian-based research method. Nurs Inq. 2003 Jun;10(2):113-20. doi: 10.1046/j.1440-1800.2003.00163.x.

  • Ghaidar D, Sippel A, Riemann-Lorenz K, Kofahl C, Morrison R, Kleiter I, Schmidt S, Dettmers C, Schulz H, Heesen C. Experiences of persons with multiple sclerosis with rehabilitation-a qualitative interview study. BMC Health Serv Res. 2022 Jun 11;22(1):770. doi: 10.1186/s12913-022-08150-8.

  • Giesler JM, Klindtworth K, Nebe A, Glattacker M. [Medical Rehabilitation in MS: Barriers to and Facilitators of its Utilization from the Patients' Perspective]. Rehabilitation (Stuttg). 2020 Apr;59(2):112-119. doi: 10.1055/a-0965-0977. Epub 2019 Aug 13. German.

  • Greenberg E, Treger I, Ring H. Rehabilitation outcomes in patients with brain tumors and acute stroke: comparative study of inpatient rehabilitation. Am J Phys Med Rehabil. 2006 Jul;85(7):568-73. doi: 10.1097/01.phm.0000223218.38152.53.

  • Gualandi R, Masella C, Viglione D, Tartaglini D. Exploring the hospital patient journey: What does the patient experience? PLoS One. 2019 Dec 5;14(12):e0224899. doi: 10.1371/journal.pone.0224899. eCollection 2019.

  • Guest G, Namey E, Chen M. A simple method to assess and report thematic saturation in qualitative research. PLoS One. 2020 May 5;15(5):e0232076. doi: 10.1371/journal.pone.0232076. eCollection 2020.

  • Hennink M, Kaiser BN. Sample sizes for saturation in qualitative research: A systematic review of empirical tests. Soc Sci Med. 2022 Jan;292:114523. doi: 10.1016/j.socscimed.2021.114523. Epub 2021 Nov 2.

  • Loft MI, Martinsen B, Esbensen BA, Mathiesen LL, Iversen HK, Poulsen I. Call for human contact and support: an interview study exploring patients' experiences with inpatient stroke rehabilitation and their perception of nurses' and nurse assistants' roles and functions. Disabil Rehabil. 2019 Feb;41(4):396-404. doi: 10.1080/09638288.2017.1393698. Epub 2017 Oct 24.

  • Loomis E, Wakasa M. Rehabilitation from meningioma. Handb Clin Neurol. 2020;170:323-331. doi: 10.1016/B978-0-12-822198-3.00051-3.

  • Luker J, Lynch E, Bernhardsson S, Bennett L, Bernhardt J. Stroke Survivors' Experiences of Physical Rehabilitation: A Systematic Review of Qualitative Studies. Arch Phys Med Rehabil. 2015 Sep;96(9):1698-708.e10. doi: 10.1016/j.apmr.2015.03.017. Epub 2015 Apr 3.

  • Mangset M, Tor Erling Dahl, Forde R, Wyller TB. 'We're just sick people, nothing else': ... factors contributing to elderly stroke patients' satisfaction with rehabilitation. Clin Rehabil. 2008 Sep;22(9):825-35. doi: 10.1177/0269215508091872.

  • Moser A, Korstjens I. Series: Practical guidance to qualitative research. Part 3: Sampling, data collection and analysis. Eur J Gen Pract. 2018 Dec;24(1):9-18. doi: 10.1080/13814788.2017.1375091. Epub 2017 Dec 4.

  • Olofsson A, Andersson SO, Carlberg B. 'If only I manage to get home I'll get better'--interviews with stroke patients after emergency stay in hospital on their experiences and needs. Clin Rehabil. 2005 Jun;19(4):433-40. doi: 10.1191/0269215505cr788oa.

  • Panday J, Velikonja D, Moll SE, Harris JE. Experiences of inpatient rehabilitation from the perspective of persons with acquired brain injury. Disabil Rehabil. 2022 Sep;44(19):5539-5548. doi: 10.1080/09638288.2021.1938706. Epub 2021 Jun 24.

  • Sadrameli SS, Chan TM, Vaziri S, Murad GJA, Hooten KG. Patient-Reported Outcomes: Quality of Care on a Neurosurgical Ward. Qual Manag Health Care. 2021 Jul-Sep 01;30(3):194-199. doi: 10.1097/QMH.0000000000000284.

  • Soratto J, Pires DEP, Friese S. Thematic content analysis using ATLAS.ti software: Potentialities for researchs in health. Rev Bras Enferm. 2020 Apr 22;73(3):e20190250. doi: 10.1590/0034-7167-2019-0250. eCollection 2020.

  • Soundy A, Stubbs B, Roskell C. The experience of Parkinson's disease: a systematic review and meta-ethnography. ScientificWorldJournal. 2014;2014:613592. doi: 10.1155/2014/613592. Epub 2014 Nov 30.

  • Sundler AJ, Lindberg E, Nilsson C, Palmer L. Qualitative thematic analysis based on descriptive phenomenology. Nurs Open. 2019 Apr 7;6(3):733-739. doi: 10.1002/nop2.275. eCollection 2019 Jul.

  • Tholin H, Forsberg A. Satisfaction with care and rehabilitation among people with stroke, from hospital to community care. Scand J Caring Sci. 2014 Dec;28(4):822-9. doi: 10.1111/scs.12116. Epub 2014 Feb 5.

  • Tran VT, Porcher R, Tran VC, Ravaud P. Predicting data saturation in qualitative surveys with mathematical models from ecological research. J Clin Epidemiol. 2017 Feb;82:71-78.e2. doi: 10.1016/j.jclinepi.2016.10.001. Epub 2016 Oct 24.

  • Witzig-Brandli V, Lange C, Gschwend S, Kohler M. "I would stress less if I knew that the nurse is taking care of it": Multiple Sclerosis inpatients' and health care professionals' views of their nursing-experience and nursing consultation in rehabilitation-a qualitative study. BMC Nurs. 2022 Aug 23;21(1):232. doi: 10.1186/s12912-022-01013-x.

MeSH Terms

Conditions

Nervous System DiseasesStrokeParkinson DiseaseMultiple Sclerosis

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesParkinsonian DisordersBasal Ganglia DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Alberto Camuccio, doctor

    IRCCS San Camillo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alberto Camuccio, doctor

CONTACT

Enrico Dal Pozzo, doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2024

First Posted

February 16, 2024

Study Start

March 15, 2023

Primary Completion

December 8, 2024

Study Completion

March 15, 2025

Last Updated

February 16, 2024

Record last verified: 2024-02

Locations