Condition category
Mental and Behavioural Disorders
Date applied
24/05/2020
Date assigned
05/06/2020
Last edited
05/06/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The term 'pneumoconiosis' refers to a group of lung diseases caused by the inhalation - and retention in the lungs - of dusts. The most commonly occurring types of pneumoconiosis (apart from asbestos-related disease) are coal worker’s pneumoconiosis, arising from the inhalation of coal dust, and silicosis, arising from the inhalation of respirable crystalline silica (RCS) from dust from building materials based on rock, sand or clay. There is a long delay - up to 10 years or more - between exposure and onset of disease, so most new cases or deaths from pneumoconiosis reflect the working conditions of the past and occur in individuals who have retired.
Pneumoconiosis is a long-lasting lung disease that cannot be cured. Pneumoconiosis patients require their family members to take care of them as the disease progresses. The needs of pneumoconiosis caregivers have been neglected even though their mental wellbeing has been found to be negatively affected. However, there has been little research on how best to support the needs of pneumoconiosis caregivers. To fill this research gap, the aim of this study was to evaluate the effectiveness of a nurse-led education programme on caregivers’ mental health, caregiving burdens, unmet direct support and enabling needs. Caregivers were recruited from the community in Hong Kong. They participated in four nurse-led weekly 90-minute workshops.

Who can participate?
Adults aged 18 years or above who are taking care of family members with pneumoconiosis at home

What does the study involve?
The participants attended four weekly 90-minute workshops led by an experienced nurse in a community center. They filled in a questionnaire and had their body mass index (BMI) calculated from their weight and height and blood pressure measured before the first workshop, after the fourth workshop and 1 month after the fourth workshop.

What are the possible benefits and risks of participating?
The possible benefits are that the programme might improve caregivers’ mental health, reduce their caregiving burden and address their unmet direct support enabling needs.
The possible risks are that the participants might find the workshop brings up upsetting or overwhelming feelings. The project team monitored the participants' physical and psychological health during the workshops and data collection. A registered nurse, project assistant or social worker was present during the data collection and workshops. Onsite physical or psychological support was provided promptly and further referral to healthcare services was also provided if needed.

Where is the study run from?
Pneumoconiosis Mutual Aid Association (Hong Kong)

When is the study starting and how long is it expected to run for?
September 2018 to December 2019

Who is funding the study?
Pneumoconiosis Mutual Aid Association (Hong Kong)

Who is the main contact?
Dr Kin Cheung, kin.cheung@polyu.edu.hk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kin Cheung

ORCID ID

http://orcid.org/0000-0002-8419-4847

Contact details

School of Nursing
The Hong Kong Polytechnic University
Kowloon
-
Hong Kong
+852-2766-6773
kin.cheung@polyu.edu.hk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

The effectiveness of a nurse-led education programme for pneumoconiosis caregivers: a quasi-experimental study

Acronym

Study hypothesis

After attending the nurse-led education programme, pneumoconiosis caregivers will improve their mental wellbeing, reduce caregiving burdens, and unmet needs fro direct support and enabling, as compared to that before attending the programme.

Ethics approval

Aprroved 11/9/2018, Hong Kong Polytechnic University School of Nursing Departmental Research Committee (Hung Hom, Kowloon, Hong Kong; +852 27666378; cherrie.mok@polyu.edu.hk), ref: HSEARS20180902002

Study design

Single-group interventional non-randomised repeated-measures study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Community

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Pneumoconiosis caregivers' mental wellbeing

Intervention

After enrolment, participants were informed about the venue of the workshops. They were informed that they would attend four weekly 90-min workshops led by an experienced nurse. They were also required to fill in a questionnaire and undergo measurement of their BMI and blood pressure before the first workshop, after the fourth workshop and 1 month after the fourth workshop. The questionnaire and measurement took about 15 min.

The four educational workshops were on the following topics:
1. Knowing pneumoconiosis and chest percussion
2. Aging process and lifting and transfer techniques
3. Home safety and medication, and assisted feeding techniques
4. Infection prevention and caring for caregivers
Each workshop involved 40 min of teaching of the knowledge and skills demonstration and then 30 min of hands-on practice and return demonstration. The participants could use the rest of the time for questions, if any.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Psychological distress measured by the Hospital Anxiety and Depression Scale (HADS) at baseline, after the fourth workshop, and 1 month after the fourth workshop

Secondary outcome measures

1. Caregiver burden measured by the Caregiver Burden Inventory
2. Caregiving burden measured by the Caregiving Burden Scale
3. Unmet needs of caregivers measured by Carer Support Needs Assessment Tool
4. BMI calculated from the participant's weight and height measured using a scale
5. Blood pressure measured using a portable blood pressure monitor

All secondary outcome measures were assessed at baseline, after the fourth workshop, and 1 month after the fourth workshop.

Overall trial start date

12/09/2018

Overall trial end date

31/12/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged ≥18 years
2. Taking care of family members with pneumoconiosis at home

Participant type

Carer

Age group

Adult

Gender

Both

Target number of participants

50

Total final enrolment

49

Participant exclusion criteria

Non-Chinese speaking caregivers

Recruitment start date

01/08/2018

Recruitment end date

01/09/2019

Locations

Countries of recruitment

Hong Kong

Trial participating centre

Pneumoconiosis Mutual Aid Association
1 to 4, G / F Chang On Building Nanchang Village Sham Shui Po
Kowloon
-
Hong Kong

Sponsor information

Organisation

Pneumoconiosis Mutual Aid Association

Sponsor details

Unit 1-4 G/F.
Cheong On House
Nam Cheong Estate
Sham Shui Po
Kowloon
-
Hong Kong
+852-238161666
Pmaahk@gmail.com

Sponsor type

Other

Website

Funders

Funder type

Charity

Funder name

Pneumoconiosis Mutual Aid Association

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The results of the study will be disseminated through journal papers, conference, and sharing sessions.

IPD sharing statement:
Ethical approval does not permit data sharing. Participants did not consent to data sharing.

Intention to publish date

31/07/2020

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

05/05/2020: Trial's existence confirmed by the Hong Kong Polytechnic University.