To evaluate the effect and feasability of a short support program for patients with IPF and their partners. The secondary objective is to explore if hair cortisol, as a measure of chronic stress, is a feasible biomarker for Quality of Life in IPF.
ID
Source
Brief title
Condition
- Lower respiratory tract disorders (excl obstruction and infection)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To evaluate the effect of a short educational program for patients with IPF and
their partners on quality of life measured with K-BILD.
Secondary outcome
-to explore if hair cortisol values change before and after the program
-to explore if changes in perceived stress and anxiety measured with
questionnaires correlate with hair cortisol values
-to explore if outcomes of the questionnaires focusing on quality of life,
health status, anxiety and depression and stress change before and after the
program.
-to assess if there is there a learning effect evaluated by IPF specific
questions.
Background summary
Idiopathic Pulmonary Fibrosis (IPF) is a specific form of pulmonary fibrosis of
unknown etiology. IPF has a progressive and irreversible course and the mean
survival is 2.5-3.5 years after diagnosis. No curative medication exists and
life expectancy is short. At the moment, there is only one registered medicine
that appears to slow the disease progression. For a small group of patients,
lung transplantation can prolong survival. Therefore, interventions focused on
improving Quality of Life are an important aspect of clinical care in IPF.
A short support program focusing on education on IPF, psychosocial support and
physiotherapy for patients and partners could lead to a better QoL, by
improving knowledge about the disease and eliminating uncertainties. Chronic
diseases with great impact on QoL are often accompanied by high perceived
stress levels. Chronic stress has been associated with high cortisol levels.
However, cortisol levels in blood, saliva and urine are highly variable during
the day and therefore findings only show real time information. Cortisol levels
measured in scalp hair provide a marker for long-term cortisol exposure and are
not subject to the limitations of time-point measurements. Using this
relatively novel method, chronically increased cortisol has been linked to
stress exposure and decreased mental health.
Study objective
To evaluate the effect and feasability of a short support program for patients
with IPF and their partners.
The secondary objective is to explore if hair cortisol, as a measure of chronic
stress, is a feasible biomarker for Quality of Life in IPF.
Study design
Prospective intervention pilot study
Intervention
Support program for patients with IPF and their partners.
Study burden and risks
Participants will be asked to attend 3 afternoons, each with a duration of 3
hours, in the hospital for an educational program. Also, participants will be
asked to fill in a set of questionnaires at 4 designated moments. For patients
this set consists of 5 questionnaires, for partners this set contains 3
questionnaires. Before and after the program, knowledge about IPF is tested,
using 10 IPF specific questions. After the program, a hair sample of
approximately 150 hairs (20mg) will be collected from all participants that
consented. This will be done in such way that it is not or barely visible where
the sample was taken. This procedure will take 5 minutes. Hair samples can be
taken during a regular scheduled outpatient clinic visit or the researcher can
come to the participators at home. Attending the program, filling in
questionnaires and taking hair samples is not expected to change the course of
the disease or cause side effects.The advantage is that patients and partner
receive extra education and coaching during these meetings. The participants
will have the opportunity to continue the support groups after the program has
ended. The control group will be asked to fill in a set of questionnaires (same
as the patients and partners attending the program) at 4 designated moments.
Filling in questionnaires is not expected to change the course of the disease
or cause side effects.
's Gravendijkwal 230
Rotterdam 3015CE
NL
's Gravendijkwal 230
Rotterdam 3015CE
NL
Listed location countries
Age
Inclusion criteria
For patients only:
- Diagnosis of IPF according to the guidelines of 2011
-Forced Vital Capacity (FVC) >=45% from predicted, and if available diffusion capacity for carbon monoxide (DLCO) >= 25% from predicted;For patients and partners (a partner is defined as a marital partner, family member or other close contact):
-Willing and able to attend three afternoons in the outpatient clinic and to complete questionnaires.
-Able to speak, read and write in Dutch
-Written informed consent
Exclusion criteria
For patients only:
- Estimated life expectancy less than 1 year;For patients and partners (a partner is defined as a marital partner, family member or other close contact)
- Unable to provide informed consent
- History of severe psychiatric disease
- If consent for hair sampling is given: use of steroids (systemic, inhalation, intra articular etc. ) in the past year.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL48553.078.14 |