Acceptance-based Healthy Lifestyles Program for Patients With Pneumoconiosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese University of Hong Kong
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ethnic Chinese who is able read and speak Chinese.
Adults aged 18 or over.
Taking compensation for pneumoconiosis.
Disqualifiers
Those who have mental, visual, hearing, or cognitive impairments with regular medical follow-ups and treatment.
Those who are unable to give written consent.
Trial design
Design model
Sequential
Treatments tested in this trial
Acceptance-based healthy lifestyles program (intervention group)
Other interventionThe 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.
Acceptance-based healthy lifestyles program (control group)
Other interventionThe 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: ControlActive comparator 1 intervention
Group B: InterventionExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Baseline, week 6, and week 14Secondary outcomes
1
Exercise-related outcome
Measured by Self-Efficacy for Exercise scale Chinese version The Chinese scale has 9 items, 11-point Likert scale. A higher total score indicates people have more self-efficacy to do exercise, range from 0 to 90.
Time frame
Baseline, week 6, and week 142
Practice of healthy diet
Measured by the diet subscale of the Chinese version of Health Promoting Lifestyle Profile II The subscale consists of 8 items to assess the practice of healthy diet. It is a 4-point Likert scale that a higher score indicates the more practice of healthy diet (range 8 to 32).
Time frame
Baseline, week 6, and week 143
Blood pressure
Measured by validated and reliable upper-arm automated system after resting for 20 min
Time frame
Baseline, week 6, and week 144
Waist circumference
Measured in nearest 0.1 centimeter
Time frame
Baseline, week 6, and week 14Sponsors and contacts
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Source ClinicalTrials.gov