Last 3 Months of Life in Home Ventilated Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00553046
Recruitment Status : Completed
First Posted : November 2, 2007
Last Update Posted : February 4, 2016
Information provided by (Responsible Party):
Michele Vitacca, Fondazione Salvatore Maugeri

Brief 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).

Condition or disease Intervention/treatment
Respiratory Failure Other: survey administration

Detailed 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.

Study Type : Observational
Actual Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Italian Multicenter Survey on the Last 3 Months of Life in Patients Ventilated at Home
Study Start Date : January 2005
Actual Primary Completion Date : January 2007
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. level of family burden [ Time Frame: 3 months after patient's death ]

Secondary Outcome Measures :
  1. influence of diagnosis and modality of ventilation [ Time Frame: 3 months after patient's death ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Home MV patients in the last 3 months of life

Inclusion criteria:

All patients mechanically ventilated at home who died

Exclusion criteria:

patients with cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00553046

FSM Respiratory Unit
Lumezzane, BS, Italy, 25065
Sponsors and Collaborators
Fondazione Salvatore Maugeri
Principal Investigator: michele vitacca, MD Fondazione S. Maugeri IRCCS

Publications of Results:
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

Other Publications:
Responsible Party: Michele Vitacca, Principal Investigator, Fondazione Salvatore Maugeri Identifier: NCT00553046     History of Changes
Other Study ID Numbers: N°159
First Posted: November 2, 2007    Key Record Dates
Last Update Posted: February 4, 2016
Last Verified: October 2007

Keywords provided by Michele Vitacca, Fondazione Salvatore Maugeri:
end of life
mechanical ventilation
CRF home ventilated patients

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