Last 3 Months of Life in Home Ventilated Patients | NCT00553046

Studies
Last 3 Months of Life in Home Ventilated Patients

NCT00553046

Sponsor

Fondazione Salvatore Maugeri

Status

Completed

Last Update Posted

Feb 4, 2016Estimated

Enrollment

180Actual

Phase

Not provided

Conditions

Respiratory Failure

Interventions

survey administration

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2005

Primary Completion Date

Jan 2007Actual

Completion Date

Apr 2007Actual

First Submitted Date

Oct 31, 2007

First Submission Date that Met QC Criteria

Nov 1, 2007

First Posted Date

Nov 2, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 3, 2016

Last Update Posted Date

Feb 4, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Michele Vitacca, Principal Investigator, Fondazione Salvatore MaugeriPrincipal Investigator

Lead Sponsor

Fondazione Salvatore MaugeriOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

180Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
family burden		chronich respiratory failure home ventilated patients	Other: survey administration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
survey administration	Other	application of a family survey on last 3 months of life for their relatives under HMV	family burden

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
level of family burden		3 months after patient's death

Secondary Outcomes

Measure	Description	Time Frame
influence of diagnosis and modality of ventilation		3 months after patient's death

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

All patients mechanically ventilated at home who died

Exclusion criteria:

patients with cancer

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Home MV patients in the last 3 months of life

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
michele vitacca, MD	Fondazione S. Maugeri IRCCS	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
FSM Respiratory Unit		Lumezzane	BS	25065	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
9917120	Background	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.
	Result	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

ID	Term
D012131	Respiratory Insufficiency
D029424	Pulmonary Disease, Chronic Obstructive
D003643	Death

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases