ClinicalTrials.gg
Not yet recruitingNCT06953050SPESUpdated May 1, 2025

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

An observational study in Parkinson Disease (PD) and Self-Care Ability, sponsored by Giovanni Muttillo. Not yet recruiting. Per ClinicalTrials.gov, last updated 2025-05-01.

Sponsored by Giovanni Muttillo · Observational

From the registry’s dates

  • Primary completion was expected by May 2026, 5 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
311
Sex
All
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Study 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.

Read the 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).

02

Conditions studied

  • Parkinson Disease (PD)
  • Self-Care Ability

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Keywords

  • malattia di parkinson
  • self-care
  • nurse
03

In context

Parkinson Disease

4,583 studies on the registry are indexed under Parkinson Disease; 1,097 are open to participants now.

This study's planned enrollment of 311 is above the median of 97 across 1,081 observational studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

This is the only study on the registry with Giovanni Muttillo as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Caregivers and patients with idiopathic Parkinson's disease

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
311 participants (estimated)
Patient registry
No

Groups and cohorts

  • Group 1

    Patient

  • Group 2

    Caregiver

06

What researchers measure

Primary outcomes

  1. Self-care

    Self Care of Chronic Illness Inventory versione 2

    Time frame: Baseline

  2. Self-care caregiver

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

    Time frame: Baseline

Secondary outcomes

  1. Perception of quality of life

    WHOQOL-BREF

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

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. PubMed 41193192 ↗

Individual participant data

Plan to share: No — SHARING WITH OTHER RESEARCHERS IS NOT NECESSARY

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for May 2025; primary completion for May 2026, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 22, 2025
First posted
May 1, 2025
StartEst.
May 2025
Primary completionEst.
May 2026
CompletionEst.
May 2026
Last update
May 1, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06953050
Lead sponsor
Giovanni Muttillo
Responsible party
Giovanni Muttillo (Director of Nursing Services Giovanni Muttillo, ASST Gaetano Pini-CTO) — Sponsor-investigator
First posted
May 1, 2025
Start date
May 2025 (estimated)
Primary completion
May 2026 (estimated)
Completion
May 2026 (estimated)
Last update
May 1, 2025

Study contacts

Giovanni Muttillo, Director
Contact
muttillo63@gmail.com
+39 3284156952

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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