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Recruiting NCT06563674

Acceptance-based Healthy Lifestyles Program for Patients With Pneumoconiosis

No phase Interventional Pneumoconiosis Healthy Lifestyle

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Acceptance-based healthy lifestyles program (intervention group), Acceptance-based healthy lifestyles program (control group).
Who it may be relevant to
Registry conditions: Pneumoconiosis, Healthy Lifestyle. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Nurse-led Acceptance-based Healthy Lifestyles Program for Community-dwelling Patients With Pneumoconiosis: A Waitlist Pilot Randomized Controlled Trial

Overview

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.

Interventions

  • Other 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.
  • 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.

Primary outcome measures

  • Psychological flexibility [Time frame: Baseline, week 6, and week 14]
Secondary outcome measures (6)
  • Exercise-related outcome [Time frame: Baseline, week 6, and week 14]
  • Practice of healthy diet [Time frame: Baseline, week 6, and week 14]
  • Blood pressure [Time frame: Baseline, week 6, and week 14]
  • Waist circumference [Time frame: Baseline, week 6, and week 14]
  • Body weight [Time frame: Baseline, week 6, and week 14]
  • Glycated hemoglobin (HbA1c) [Time frame: Baseline and week 14]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Single blind
Primary purpose
Other

Study locations

Hong Kong · 1 center
  • PMAA — Hong Kong

Identifiers

NCT: NCT06563674 · temp

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗