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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Parkinson Disease (PD), Self-Care Ability. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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).
Primary outcome measures
- Self-care [Time frame: Baseline]
- Self-care caregiver [Time frame: Baseline]
Secondary outcome measures (1)
- Perception of quality of life [Time frame: Baseline]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Petralito M, Tedesco C, Isaias IU, Muttillo G, Castaldo A, Pucciarelli G, Caruso R. Self-care and its assessment in the patient-caregiver dyad in Parkinson's disease: a mixed-method study protocol. BMJ Open. 2025 Nov 4;15(11):e107471. doi: 10.1136/bmjopen-2025-107471. PMID 41193192
Identifiers
NCT: NCT06953050 · ID 5732 parere numero 5732_12