Tokyo, June 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061909) titled 'A Randomized Controlled Trial of a Tele Nursing Supported Crisis Plan for Psychological Well-Being in Patients with Parkinson's Disease' on June 15.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - IRYO SOUSEI UNIVERSITY
Condition:
Condition - Parkinson's Disease
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This exploratory randomized controlled trial aims to evaluate the feasibility and preliminary effectiveness of a tele nursing supported crisis planning intervention for patients with Parkinson's disease and to provide data for the design of a future definitive trial.
Basic objectives2 - Safety
Intervention:
Interventions/Control_1 - Tele nursing supported crisis planning + usual care
Interventions/Control_2 - usual care
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients with stable medical conditions who participate in online communication.
Key exclusion criteria - Patients with an unstable medical condition that precludes participation in online communication.
Patients with cognitive impairment that interferes with study participation.
Target Size - 60
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2025 Year 09 Month 17 Day
Date of IRB - 2025 Year 10 Month 24 Day
Anticipated trial start date - 2026 Year 06 Month 01 Day
Last follow-up date - 2028 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070840
Disclaimer: Curated by HT Syndication.
