Last 3 Months of Life in Home Ventilated Patients

This study has been completed.
Sponsor:
Information provided by:
Fondazione Salvatore Maugeri
ClinicalTrials.gov Identifier:
NCT00553046
First received: October 31, 2007
Last updated: July 6, 2011
Last verified: October 2007
  Purpose

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).


Condition Intervention
Respiratory Failure
Other: survey administration

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Italian Multicenter Survey on the Last 3 Months of Life in Patients Ventilated at Home

Resource links provided by NLM:


Further study details as provided by Fondazione Salvatore Maugeri:

Primary Outcome Measures:
  • level of family burden [ Time Frame: 3 months after patient's death ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • influence of diagnosis and modality of ventilation [ Time Frame: 3 months after patient's death ] [ Designated as safety issue: No ]

Enrollment: 180
Study Start Date: January 2005
Study Completion Date: April 2007
Groups/Cohorts Assigned Interventions
family burden
chronich respiratory failure home ventilated patients
Other: survey administration
application of a family survey on last 3 months of life for their relatives under HMV
Other Name: caregiver burden

Detailed Description:

Participants: 168 patients' relatives presenting five categories of diseases (Chronic Obstructive Pulmonary Disease-Amyotrophic 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Home MV patients in the last 3 months of life

Criteria

Inclusion criteria:

All patients mechanically ventilated at home who died

Exclusion criteria:

patients with cancer

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00553046

Locations
Italy
FSM Respiratory Unit
Lumezzane, BS, Italy, 25066
Sponsors and Collaborators
Fondazione Salvatore Maugeri
Investigators
Principal Investigator: michele vitacca, MD Fondazione S. Maugeri IRCCS
  More Information

Publications:
Responsible Party: michele vitacca, Fondazione Salvatore Maugeri
ClinicalTrials.gov Identifier: NCT00553046     History of Changes
Other Study ID Numbers: N°159
Study First Received: October 31, 2007
Last Updated: July 6, 2011
Health Authority: Italy: National Bioethics Committee

Keywords provided by Fondazione Salvatore Maugeri:
ethics
COPD
end of life
mechanical ventilation
CRF home ventilated patients

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014