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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 23, 2014