Acceptance-based Healthy Lifestyles Program for Patients With Pneumoconiosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2026-01-31

Brief Summary

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Symptoms, such as cough and shortness of breath, are common among patients with pneumoconiosis. Depression and anxiety can be elicited by the symptoms, while avoidance of daily activities is believed to reduce trigger of symptoms. The lung function is then declined and the risk of having stroke and heart failure is increased. The objectives of this 2-arm waitlist pilot randomized controlled trial are to test the effects and feasibility of an acceptance-based educational program among patients with pneumoconiosis. 80 participants will be recruited from community centers and randomly assigned to intervention group or waitlist-control group in a ratio of 1:1. The 6-week group-based educational program will be provided to the intervention group first, then the waitlist-control group. The program consists of 4 sessions integrated with acceptance components and care of pneumoconiosis. Their psychological health, healthy lifestyles, and cardiometabolic profiles will be assessed at baseline, week 6, and week 14. Data will be analyzed using a statistical package. The feasibility of the program will be evaluated by interview. The findings of this study can inform the integration of acceptance-based intervention into pneumoconiosis management in Hong Kong, and future study on chronic progressive lung diseases.

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Detailed Description

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Conditions

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Pneumoconiosis Healthy Lifestyle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

A 2-arm waitlist pilot randomized controlled trial will be adopted. After baseline data collection, participants in the intervention group will receive the health program for 6 weeks. On the other hand, participants in the waitlist-control group will receive the same health program week 8 and week 14.

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

The baseline data will be collected by research assistant (RA)1 before randomization, while the follow-ups data will be collected by RA2. The participant's group allocation is masked to the outcome assessors. But the participants know their group allocation after randomization because of the nature of the intervention. Different dates will be planned for different groups for all follow-ups respectively to avoid contamination of the subjects and blinding to the outcome assessors as far as possible

Study Groups

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Control

Participants will receive the acceptance-based healthy lifestyles program between week 8-14.

Group Type ACTIVE_COMPARATOR

Acceptance-based healthy lifestyles program (control group)

Intervention Type OTHER

The acceptance-based healthy lifestyles program consists of 4 biweekly 60-min face-to-face interactive workshops to cover the knowledge of pneumoconiosis, exercise to maintain lung function, health diet, and home safety.

Intervention

Participants will receive the acceptance-based healthy lifestyles program between week 1-6.

Group Type EXPERIMENTAL

Acceptance-based healthy lifestyles program (intervention group)

Intervention Type OTHER

The acceptance-based healthy lifestyles program consists of 4 biweekly 60-min face-to-face interactive workshops to cover the knowledge of pneumoconiosis, exercise to maintain lung function, health diet, and home safety.

Interventions

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Acceptance-based healthy lifestyles program (intervention group)

The acceptance-based healthy lifestyles program consists of 4 biweekly 60-min face-to-face interactive workshops to cover the knowledge of pneumoconiosis, exercise to maintain lung function, health diet, and home safety.

Intervention Type OTHER

Acceptance-based healthy lifestyles program (control group)

The acceptance-based healthy lifestyles program consists of 4 biweekly 60-min face-to-face interactive workshops to cover the knowledge of pneumoconiosis, exercise to maintain lung function, health diet, and home safety.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Ethnic Chinese who is able read and speak Chinese.
2. Adults aged 18 or over.
3. Taking compensation for pneumoconiosis.

Exclusion Criteria

1. Those who have mental, visual, hearing, or cognitive impairments with regular medical follow-ups and treatment.
2. Those who are unable to give written consent.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No