Last 3 Months of Life in Home Ventilated Patients

Respiratory Failure Clinical Trial

Official title:

Italian Multicenter Survey on the Last 3 Months of Life in Patients Ventilated at Home

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00553046
• Other study ID #: N°159
• Status: Completed
• Phase: N/A
• First received: October 31, 2007
• Last updated: February 3, 2016
• Start date: January 2005
• Est. completion date: April 2007

Study information

• Verified date: October 2007
• Source: Fondazione Salvatore Maugeri
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Bioethics Committee
• Study type: Observational

Clinical Trial Summary

To verify with a specific questionnaire, the families' perceived quality of end-of-life care and of dying in the last 3 months of life of 168 patients (Chronic Obstructive Pulmonary Disease-Amyotrophic Lateral Sclerosis (ALS)-Restrictive disorders-Neuromuscular disease- others) with chronic respiratory failure needing domiciliary mechanical ventilation (MV).

Description:

Participants: 168 patients' relatives presenting five categories of diseases (Chronic Obstructive Pulmonary Disease-Amyothrophic Lateral Sclerosis (ALS)-Restrictive disorders-Neuromuscular disease- others) answered to questionnaire.

Interventions: none Measurements and Main Results: 35 questions grouped in 6 specific domains (Control of pain and symptoms (domain 1-D1), awareness of disease (D2), family burden (D3), the process of dying (D4), medical troubles including hospitalizations (D5) and technical problems linked to MV(D6) were asked after the patient's death to a family member by means of a face to face interview. Answers to the binary 35-item questionnaire were distributed into just two clusters per each domain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: April 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion criteria:

All patients mechanically ventilated at home who died

Exclusion criteria:

patients with cancer

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

Other:
• survey administration
application of a family survey on last 3 months of life for their relatives under HMV

Locations

Country	Name	City	State
Italy	FSM Respiratory Unit	Lumezzane	BS

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Salvatore Maugeri

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Singer PA, Martin DK, Kelner M. Quality end-of-life care: patients' perspectives. JAMA. 1999 Jan 13;281(2):163-8. — View Citation

Vitacca M, Comini L & Barbano L. Home mechanical ventilation difficulties in the last 3 months of life as reported by caregivers. J Med Pers 11:30-36, 2013. DOI 10.1007/s12682-012-0128-8

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	level of family burden		3 months after patient's death	No
Secondary	influence of diagnosis and modality of ventilation		3 months after patient's death	No