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SELF-CARE IN PARKINSON'S DISEASE: A STUDY ON PATIENTS AND CAREGIVERS/Self-care in the Patient-caregiver Dyad With Parkinson's Disease: A Descriptive Observational Study

SELF-CARE IN PARKINSON'S DISEASE: A STUDY ON PATIENTS AND CAREGIVERS/Self-care in the Patient-caregiver Dyad With Parkinson's Disease: A Descriptive Observational Study

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06953050
Acronym
SPES
Enrollment
311
Registered
2025-05-01
Start date
2025-05-31
Completion date
2026-05-31
Last updated
2025-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease (PD), Self-Care Ability

Keywords

malattia di parkinson, self-care, nurse

Brief summary

This descriptive observational study will involve dyads of Parkinson Disease patients and their caregivers. Participants will be recruited from the Parkinson's Disease and Movement Disorders Centre of ASST Gaetano Pini-CTO. Validated questionnaires, such as the WHOQOL-Bref, the Self-care of Chronic Illness Inventory version 2, and the Caregiver Self-efficacy in Contributing to Self-care Scale, will be administered. The study will also include semi-structured interviews to gather qualitative data on the patients' and caregivers' perceptions of self-care. A non-probabilistic convenience sampling method will be used, with the inclusion of both patients at any disease stage and their primary caregivers. The sample size will range 311 dyads with 5% margin of error.

Detailed description

The primary objective of this study is to describe the proportion of self-care maintenance in the population with Parkinson's Disease and their respective caregivers. Gaining an in-depth understanding of the phenomenon in its experiential and perceptual components, as well as the meanings attributed to it, is essential for developing and validating a new tool capable of assessing and measuring self-care in Parkinson's Disease. The secondary objectives are (a) to describe the proportions of self-care monitoring and management in the population with Parkinson's Disease and their respective caregivers; (b) to explore the meaning attributed by patients with Parkinson's Disease to self-care in its three dimensions: self-care maintenance, monitoring, and management; (c) to describe the attitudes and self-care behaviours adopted by patients with Parkinson's Disease across different disease stages; (d) to explore the meaning attributed by caregivers of patients with Parkinson's Disease to self-care in its three dimensions: self-care maintenance, monitoring, and management; (e) to describe the attitudes and self-care behaviours adopted by caregivers of patients with Parkinson's Disease across different disease stages; (f) to identify the dimensions of self-care and the constructs that should be represented within the items of the new instrument, the Parkinson's Disease Self-care Questionnaire (PDSC-Q).

Interventions

None listed

Sponsors

Giovanni Muttillo
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Spatial-temporal orientation * Identifying as the primary caregiver of the person * Understanding of the Italian language * Consent to participate in the study * Informal caregiver

Exclusion criteria

* Secondary forms of Parkinson's Disease * Subjects with cognitive impairments, assessed with the Mini Mental State Examination; score lower than 24/30 Subjects who do not understand written and spoken Italian Subjects who did not provide consent to participate in the study

Design outcomes

Primary

MeasureTime frameDescription
Self-careBaselineSelf Care of Chronic Illness Inventory versione 2
Self-care caregiverBaselineCaregiver Self-efficacy in Contributing to self-care scale (CSE-CSC)

Secondary

MeasureTime frameDescription
Perception of quality of lifeBaselineWHOQOL-BREF

Contacts

Primary ContactGiovanni Muttillo, Director
muttillo63@gmail.com+39 3284156952

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026