NCT02778347

Brief Summary

The purpose of this study is to develop and validate a comprehensive and standardised tool for assessment of patient needs in palliative care.

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
480

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2013

Longer than P75 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

Study Start

First participant enrolled

September 1, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2015

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

May 19, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

May 19, 2016

Status Verified

May 1, 2016

Enrollment Period

3 years

First QC Date

January 8, 2015

Last Update Submit

May 17, 2016

Conditions

Palliative Care

Keywords

Palliative careNeed assessmentToolsValidityQuality of care

Outcome Measures

Primary Outcomes (1)

  • Criterion-related validity: correlation between the score obtained using InterRAI-PC and scores obtained using MD Anderson Symptom Inventory (MDASI)

    InterRAI-PC Scales versus MDASI scales (Pain Scale, dyspnea scale and Depression Rating Scale)

    Baseline

Secondary Outcomes (2)

  • Sensitivity to change: change in InterRAI-PC score over 7 days from Baseline

    One Week

  • Inter-Observer Reliability of InterRAI-PC scale: correlation between score obtained by different observers (kappa coefficient)

    Baseline

Eligibility Criteria

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

Patients receiving palliative care

You may qualify if:

  • Men and Women, age ≥ 18 years
  • Patients receiving palliative care at home or in hospital at the time of screening

You may not qualify if:

  • Non consenting
  • Patient waiting a transfer within 48 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maison Médicale Jeanne Garnier

Paris, Paris, 75015, France

RECRUITING

Central Study Contacts

Frédéric Guirimand

CONTACT

33 1 43 92 21 17fguirimand@adc.asso.fr

Emmanuel BAGARAGAZA

CONTACT

33 1 43 92 21 63ebagaragaza@adc.asso.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2015

First Posted

May 19, 2016

Study Start

September 1, 2013

Primary Completion

September 1, 2016

Study Completion

July 1, 2017

Last Updated

May 19, 2016

Record last verified: 2016-05

Locations

FR(1)