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Last 3 Months of Life in Home Ventilated Patients

Sponsor
Fondazione Salvatore Maugeri (Other)
Overall Status
Completed
CT.gov ID
NCT00553046
Collaborator
(none)
180
Enrollment
1
Location
26.9
Duration (Months)
6.7
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • 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 Design

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 :
Jan 1, 2005
Actual Primary Completion Date :
Jan 1, 2007
Actual Study Completion Date :
Apr 1, 2007

Arms and Interventions

Arm 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 Names:
  • caregiver burden

    		•

    Outcome Measures

    Primary Outcome Measures

    1. level of family burden [3 months after patient's death]

    Secondary Outcome Measures

    1. influence of diagnosis and modality of ventilation [3 months after patient's death]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:

    All patients mechanically ventilated at home who died

    Exclusion criteria:

    patients with cancer

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 FSM Respiratory Unit Lumezzane BS Italy 25065

    Sponsors and Collaborators

    • Fondazione Salvatore Maugeri

    Investigators

    • Principal Investigator: michele vitacca, MD, Fondazione S. Maugeri IRCCS

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Michele Vitacca, Principal Investigator, Fondazione Salvatore Maugeri
    ClinicalTrials.gov Identifier:
    NCT00553046
    Other Study ID Numbers:
    • N°159
    First Posted:
    Nov 2, 2007
    Last Update Posted:
    Feb 4, 2016
    Last Verified:
    Oct 1, 2007
    Keywords provided by Michele Vitacca, Principal Investigator, Fondazione Salvatore Maugeri
    ethics
    COPD
    end of life
    mechanical ventilation
    CRF home ventilated patients
    Additional relevant MeSH terms:
    Respiratory Insufficiency

    Study Results

    No Results Posted as of Feb 4, 2016