Last 3 Months of Life in Home Ventilated Patients

NCT ID: NCT00553046

Last Updated: 2016-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-01-31

Study Completion Date

2007-04-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Respiratory Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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family burden

chronich respiratory failure home ventilated patients

survey administration

Intervention Type OTHER

application of a family survey on last 3 months of life for their relatives under HMV

Interventions

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survey administration

application of a family survey on last 3 months of life for their relatives under HMV

Intervention Type OTHER

Other Intervention Names

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caregiver burden

Eligibility Criteria

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Inclusion Criteria

All patients mechanically ventilated at home who died

Exclusion Criteria

patients with cancer
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Salvatore Maugeri

OTHER

Sponsor Role lead

Responsible Party

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Michele Vitacca

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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michele vitacca, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione S. Maugeri IRCCS

Locations

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FSM Respiratory Unit

Lumezzane, BS, Italy

Site Status

Countries

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Italy

References

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Singer PA, Martin DK, Kelner M. Quality end-of-life care: patients' perspectives. JAMA. 1999 Jan 13;281(2):163-8. doi: 10.1001/jama.281.2.163.

Reference Type BACKGROUND
PMID: 9917120 (View on PubMed)

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

Reference Type RESULT

Other Identifiers

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N°159

Identifier Type: -

Identifier Source: org_study_id

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