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

NCT06953050 | Not Yet Recruiting

• 1 other identifier: ID 5732 parere numero 5732_12
• Study Type: observational
• Target: 311
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Parkinson Disease (PD); Self-Care Ability

Keywords

malattia di parkinson; self-care; nurse

Outcome Measures

Primary Outcomes (2)

• Self-care

  Self Care of Chronic Illness Inventory versione 2

  Baseline

• Self-care caregiver

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

  Baseline

Secondary Outcomes (1)

• Perception of quality of life

  Baseline

Study Arms (2)

Group 1

Patient

Group 2

Caregiver

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Caregivers and patients with idiopathic Parkinson's disease

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Giovanni Muttillo: lead

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Giovanni Muttillo, Director

CONTACT

+39 3284156952; muttillo63@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Nursing Services Giovanni Muttillo

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: May 1, 2025
• Study Start: May 1, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share