NCT00553046

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2005

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 2, 2007

Completed
Last Updated

February 4, 2016

Status Verified

October 1, 2007

Enrollment Period

2 years

First QC Date

October 31, 2007

Last Update Submit

February 3, 2016

Conditions

Respiratory Failure

Keywords

ethicsCOPDend of lifemechanical ventilationCRF home ventilated patients

Outcome Measures

Primary Outcomes (1)

  • level of family burden

    3 months after patient's death

Secondary Outcomes (1)

  • influence of diagnosis and modality of ventilation

    3 months after patient's death

Study Arms (1)

family burden

chronich respiratory failure home ventilated patients

Other: survey administration

Interventions

survey administrationOTHER

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

Also known as: caregiver burden
family burden

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Home MV patients in the last 3 months of life

You may qualify if:

  • All patients mechanically ventilated at home who died

You may not qualify if:

  • patients with cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FSM Respiratory Unit

Lumezzane, BS, 25065, Italy

Location

Related Publications (2)

  • 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.

    PMID: 9917120BACKGROUND

  • 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

    RESULT

MeSH Terms

Conditions

Respiratory InsufficiencyPulmonary Disease, Chronic ObstructiveDeath

Interventions

Zarit Caregiver Burden Scale

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • michele vitacca, MD

    Fondazione S. Maugeri IRCCS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 31, 2007

First Posted

November 2, 2007

Study Start

January 1, 2005

Primary Completion

January 1, 2007

Study Completion

April 1, 2007

Last Updated

February 4, 2016

Record last verified: 2007-10

Locations

IT(1)