Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04022902 |
| Other study ID # |
PCFB2018 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 5, 2018 |
| Est. completion date |
September 30, 2019 |
Study information
| Verified date |
January 2021 |
| Source |
Chinese University of Hong Kong |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This is an exploratory qualitative study to understand the needs of patients with
pneumoconiosis, and the care-giving experience of their family caregivers. Patients with a
confirmed diagnosis of pneumoconiosis for at least 1 year and had registered with the
Pneumoconiosis Compensation Fund Board in Hong Kong to receive compensation will be eligible
to join this study. The respective family caregivers of these patients, who are 21 years of
age or older, assuming the role as the primary caregivers of a pneumoconiosis patient who
have registered with the Pneumoconiosis Compensation Fund Board will be invited to join. The
nurse will carry out an individual in-depth qualitative interview at patient's home. The
nurse will also conduct a home environment assessment. After obtaining the written consent,
an interview guide with a list of open-ended questions will be used to elicit the illness
experience and self-care needs of the pneumoconiosis patients and the caregiving experience
of their family caregivers.
Description:
Pneumoconiosis is a fibrotic pulmonary disease resulting from workplace exposure to hazardous
dusts containing free silica or asbestos, which causes irreversible progressive respiratory
impairment among the sufferers. These patients may experience disabling symptoms (e.g.
progressive severe dyspnea, chronic and uncontrolled cough, sputum production, fatigue,
activity intolerance, decreased mobility and sleep disturbance) despite optimal medical
treatment. Pneumoconiosis is considered as a chronic, progressive and incurable disease which
requires long-term comprehensive rehabilitation services and support. Effective disease
management relies on engaging patients in long-term comprehensive rehabilitation. The overall
aim of this study is to explore the illness experience and needs of patients with
pneumoconiosis, and the caregiving experience of their respective family caregivers through
home visits. The findings will provide important insight into the development of an effective
and tailor-made support program for patients with pneumoconiosis in Hong Kong.
This is an exploratory qualitative study to understand the needs of patients with
pneumoconiosis, and the care-giving experience of their family caregivers. Patients with a
confirmed diagnosis of pneumoconiosis for at least 1 year and had registered with the
Pneumoconiosis Compensation Fund Board in Hong Kong to receive compensation will be eligible
to join this study. The respective family caregivers of these patients, who are 21 years of
age or older, assuming the role as the primary caregivers of a pneumoconiosis patient who
have registered with the Pneumoconiosis Compensation Fund Board will be invited to join. The
nurse will carry out an individual in-depth qualitative interview at patient's home. The
nurse will also conduct a home environment assessment, as the home environment plays an
important role in promoting or restricting performance of everyday tasks of people with
disabling chronic diseases and their caregivers. The interviews will be conducted with the
patients and the caregivers separately, so they can talk openly and confidentiality is
guaranteed. Prior to commencement of the data collection, the nurse will provide an
information sheet to solicit participants' understanding about the nature of the study, their
rights and confidentiality issues. After obtaining the written consent, an interview guide
with a list of open-ended questions will be used to elicit the illness experience and
self-care needs of the pneumoconiosis patients and the caregiving experience of their family
caregivers. All the interviews will be audio-taped after obtaining the permission from the
participants.
This study aims to explore the illness experience and needs of patients with pneumoconiosis
and the care-giving experience of their caregivers. Specifically, the objectives of this
study are as follow:
- To understand the self-care behaviors and illness experience of patients with
pneumoconiosis
- To explore the needs of patients with pneumoconiosis when managing the disease at home
and in the community
- To understand the caregiving experience of the family caregivers of patients with
pneumoconiosis
- To explore the caregivers' needs when taking care of patients with pneumoconiosis
- To explore how disease management and caregiving take place in patients' home
environment and to identify the environment-related facilitators and barriers for
managing pneumoconiosis.
After the interview, the nurse will also conduct a home environment assessment with a
standard environmental checklist to evaluate the home for safety, modification needs and ease
of mobility. Such assessment would provide valuable information to inform the needs of
pneumoconiosis patients and their caregivers when they participate community-based and
home-based rehabilitative activities. The assessment includes the environment outside and
within patients' home environment, such as any difficulties in accessing the entrance of the
building (e.g. barrier-free entryway, no elevator for one or more floor), the use of
equipment or adaptations in the home to aid in daily activities, such as rails and commodes.
The commonly seen home environmental hazards will also be assessed, such as the exposure to
second-hand smoking, the use of nonskid mats in bathroom, grab bars in the shower or tub,
spacing and entryway in the bathroom and bedroom. Each of the item will be assessed to
solicit a 'no problem observed' or 'problem observed'.
The audio-taped qualitative data will be transcribed verbatim by the research nurse. Content
analysis will be adopted for the data analysis. In particular, the qualitative data will be
analyzed to seek a better understanding of what and how the patients and the caregivers can
be supported in their disease self-care and caregiving trajectory. The emerged themes from
the qualitative data will be used to optimize the patient support program in the subsequent
quantitative phase of the study. The home environment assessment data will be summarized by
appropriate numbers and percentages.
