Last 3 Months of Life in Home Ventilated - Full Text View

Sponsored by:	Fondazione Salvatore Maugeri
Information provided by:	Fondazione Salvatore Maugeri
ClinicalTrials.gov Identifier:	NCT00553046

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-Amyotrofic Lateral Scerosis (ALS)-Restrictive disorders-Neuromuscular disease- others) with chronic respiratory failure needing domiciliary mechanical ventilation (MV).

Condition	Intervention
Respiratory Failure	Other: No intervention

U.S. FDA Resources

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

Further study details as provided by Fondazione Salvatore Maugeri:

Primary Outcome Measures:

level of family burden [ Time Frame: 3 months after patient's death ]

Secondary Outcome Measures:

influence of diagnosis and modality of ventilation [ Time Frame: 3 months after patient's death ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	180
Study Start Date:	January 2005
Study Completion Date:	April 2007

Groups/Cohorts	Assigned Interventions
1 CRI home ventilated patients	Other: No intervention No intervention

Detailed Description:

Participants: 168 patients' relatives presenting five categories of diseases (Chronic Obstructive Pulmonary Disease-Amyotrofic Lateral Scerosis (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 died patients mechanically ventilated at home

Contacts and Locations

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

Locations

Italy, BS
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:

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

Study ID Numbers:	N°159, N°159reaserchbookFSM2006
Study First Received:	October 31, 2007
Last Updated:	December 12, 2007
ClinicalTrials.gov Identifier:	NCT00553046 History of Changes
Health Authority:	Italy: National Bioethics Committee

Keywords provided by Fondazione Salvatore Maugeri:

ethics
COPD
end of life
mechanical ventilation
CRF home ventilated patients

Study placed in the following topic categories:

Respiratory Insufficiency
Respiratory Tract Diseases
Respiration Disorders

Additional relevant MeSH terms:

Respiratory Insufficiency
Respiratory Tract Diseases
Respiration Disorders

ClinicalTrials.gov processed this record on May 06, 2009