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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02929966
Date of registration:	08/10/2016
Prospective Registration:	No
Primary sponsor:	Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Public title:	Palliative Care in Pulmonary Fibrosis PULFIP
Scientific title:	Effect of Palliative Care in Patients With End Stage Pulmonary Fibrosis: a Randomized Control Pilot Study
Date of first enrolment:	July 2016
Target sample size:	50
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02929966
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
Phase:	N/A

Countries of recruitment
Italy

Contacts

Key inclusion & exclusion criteria

Inclusion Criteria:

- diagnosis of idiophatic pulmonary fibrosis

- resting partial arterial oxygen pressure (PaO2) < 60 mmHg

- Decline in Forced Vital Capacity (FVC) > 10% in the last 6 months

- stage 3 according to the GAP index

Exclusion Criteria:

- active treatment with antifibrotic drug

- concomitant cancer

Age minimum: 18 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Idiophatic Pulmonary Fibrosis

Intervention(s)

Other: standard respiratory care

Other: palliative care program

Primary Outcome(s)

dyspnea score [Time Frame: 12 months]

clinical status and quality of life [Time Frame: 12 months]

depression [Time Frame: 12 months]

Secondary Outcome(s)

survival [Time Frame: 12 months]

Secondary ID(s)

120/2016/O/Sper

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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