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

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.

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Key information

Conditions

Parkinson Disease (PD) Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Self-Care Ability Synucleinopathies

Sex eligibility

All sexes

Study type

Observational

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Self-care

Time frame: Baseline

Self Care of Chronic Illness Inventory versione 2
Self-care caregiver

Time frame: Baseline

Caregiver Self-efficacy in Contributing to self-care scale (CSE-CSC)

Secondary outcomes

Perception of quality of life

Time frame: Baseline

WHOQOL-BREF

Study contacts

Contact information is provided by the study sponsor or research team.

Giovanni Muttillo, Director

CONTACT

[email protected]

+39 3284156952

Sponsors and collaborators

Lead sponsor

Giovanni Muttillo

Other

Registry information

Acronym: SPES

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: May 1, 2025
Registry last updated: May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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