Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06434545
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-05-23
Brief Title:
Symptom Management Essentials at Home
Sponsor:
UMC Utrecht
Organization:
UMC Utrecht
Study Overview
Official Title:
SMEtH - Symptom Management Essentials at Home
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SMEtH
Brief Summary:
A cluster Randomized Controlled Trial cRCT that aims to determine the effect of the Palliative Reasoning PR methodology on the quality of life and symptom burden of patients dealing with a life-limiting illness and their loved ones receiving palliative care services at home Palliative Reasoning will be implemented from the first of may 2024 to 30 april 2025 in twenty nursing teams of a large homecare organization in Utrecht the Netherlands and will be compared with twenty control nursing teams The effect of PR will be measured by means of questionnaires filled out by clients with a life expectancy of less than one year according to the surprise question Would I be surprised if this person would die within one year and family caregivers Parallel to the effect study a process evaluation will be conducted in order to understand the implications of the results and its societal and practical impact
Detailed Description:
The Palliative Reasoning PR methodology has been developed by University Medical Centre Utrecht UMCU in collaboration with the Netherlands Comprehensive Cancer organization IKNL to support nursing teams and other HCPs with the inter- and intradisciplinary communication and the early recognition analysis and treatment of symptoms in patients requiring palliative care This stepwise iterative approach starts with HCPs identifying patients with palliative care needs by asking the surprise question Would I be surprised if this patient would die within one year If the answer to the previous question is no indicating not being surprised a patient can be marked as being in a palliative phase of life After the identification of the patient the method follows four steps 1 Map out current symptoms values wishes and needs of patient and loved ones 2 Analyze symptoms 3 develop a proactive treatment plan 4 Make agreements for the evaluation of the treatment plan
After the training twenty of the forty nursing teams working for a large homecare organization patients and family caregivers of both intervention teams and control teams can be included The perceived symptom control quality of life and symptom burden of patients and symptom burden of family caregivers will be compared between intervention and control teams to assess the effectiveness of the intervention
After the training twenty of the forty nursing teams working for a large homecare organization patients and family caregivers of both intervention teams and control teams can be included The perceived symptom control quality of life and symptom burden of patients and symptom burden of family caregivers will be compared between intervention and control teams to assess the effectiveness of the intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None