NCT06151886

Brief Summary

In Denmark, life-dependent home-mechanical ventilation (HMV) is given under the surveillance of a specifically trained respiratory patient caregiver (tPCG). The HMV can be invasive through a tracheostomy or non-invasive via a mask. The purpose of this study is to uncover experiences and challenges associated with having a trained respiratory patient care giver (tPCG) to surveil home-mechanical ventilation (HMV) from the perspective of the patients and their families and to gather information about the expirence of working in a home as a tPCG

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

September 6, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

September 18, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 30, 2023

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

2 months

First QC Date

September 6, 2023

Last Update Submit

November 21, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Severe respiratory insufficiency questionnaire

    The patients will be asked to fullfill the questionnaire

    Assessed within the last 7 days

Study Arms (3)

Patients

Relatives

Trained respiratory patient caregiver

Eligibility Criteria

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

All patients assigned with a trained patient care giver to surveil the respiratory treatment (invasive and noninvasive mechanical ventilation) and working on the responsibility of the Respiratory Center East, their relatives as well as trained respiratory patient caregivers working on the responsibility of the Respiratory Center East

You may qualify if:

  • Patient Age \> 18 years Has trained patient care givers to surveil the respiratory treatment and working on the responsibility of the Respiratory Center East
  • Parent Age \> 18 years Has a child less than 18 years old with tPCG, working on the responsibility of the Respiratory Center East, to surveil the home-mechanical ventilation
  • Other relative:
  • Age \> 18 years Involved in the treatment or support of a relative with tPCG, working on the responsibility of the Respiratory Center East, to surveil the home-mechanical ventilation
  • Trained patient caregivers (tPCG) Age \> 18 years Employed by an external agency or by the patient (BPA) to surveil home-mechanical ventilation Certified as tPCG working on the responsibility of the Respiratory Center East

You may not qualify if:

  • No informed consent to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anaesthesia, Pain and REspiratory Support

Glostrup Municipality, 2600, Denmark

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, clinical associate professor

Study Record Dates

First Submitted

September 6, 2023

First Posted

November 30, 2023

Study Start

September 18, 2023

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

November 30, 2023

Record last verified: 2023-11

Locations