Acceptance-based Healthy Lifestyles Program for Patients With Pneumoconiosis

NCT06563674 | Recruiting

• 1 other identifier: temp
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pneumoconiosis; Healthy Lifestyle

Keywords

Pneumoconiosis; Healthy Lifestyle; Acceptance-based

Outcome Measures

Primary Outcomes (1)

• Psychological flexibility

  Measured by Acceptance and Action Questionnaire-II Chinese version. It is a 7-point Likert scale with 7 items. The score ranges from 7 to 49 and a higher total score indicates less flexibility.

  Baseline, week 6, and week 14

Secondary Outcomes (6)

• Exercise-related outcome

  Baseline, week 6, and week 14

• Practice of healthy diet

  Baseline, week 6, and week 14

• Blood pressure

  Baseline, week 6, and week 14

• Waist circumference

  Baseline, week 6, and week 14

• Body weight

  Baseline, week 6, and week 14

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Other: Acceptance-based healthy lifestyles program (control group)

Intervention

EXPERIMENTAL

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

Other: Acceptance-based healthy lifestyles program (intervention group)

Interventions

Acceptance-based healthy lifestyles program (intervention group) 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

Acceptance-based healthy lifestyles program (control group) 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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

PMAA

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Pneumoconiosis

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Lung Injury; Occupational Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Hon Lon Tam, PhD

CONTACT

39439306; hltam@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 21, 2024
• Study Start: November 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: January 1, 2026
• Last Updated: April 13, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)