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Trial registered on ANZCTR
Registration number
ACTRN12618001905257
Ethics application status
Approved
Date submitted
20/11/2018
Date registered
22/11/2018
Date last updated
15/06/2021
Date data sharing statement initially provided
22/11/2018
Date results information initially provided
15/06/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
Education Program for people with Chronic Obstructive Pulmonary Disease
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Scientific title
Evaluation of a psychoeducational intervention for people with chronic obstructive pulmonary disease: a mixed methods study
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Secondary ID [1]
296658
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None
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Universal Trial Number (UTN)
U1111-1224-2740
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
chronic obstructive pulmonary disease
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symptoms of anxiety
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symptoms of depression
310497
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Condition category
Condition code
Respiratory
309204
309204
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0
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Chronic obstructive pulmonary disease
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Mental Health
309205
309205
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0
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Anxiety
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Mental Health
309206
309206
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0
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Depression
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Name: psychoeducational intervention for people with COPD
The aims of intervention are to alleviate the symptoms of anxiety and depression and improve health-related quality of life in people with COPD by increasing individuals’ daily self-management skills. The psychoeducational intervention is an adaptation of the Stanford Chronic Disease Self-management Program (CDSMP) developed in the United States.
Ruixue Cao, the Phd Candidate of the University of Newcastle, will delivery the intervention. Her supervisors Prof. Sally Chan and Dr Graeme Browne will provide guidance during the intervention delivery.
The psychoeducational intervention is a face to face group intervention, which consisted of weekly action planning, modelling of behaviours, problem solving, interpretation of symptoms, symptoms management techniques, individual decision making and feedback. Topics of psychoeducational intervention covered include: 1)techniques to cope with issues like fatigue, isolation and pain; 2) appropriate exercise aiming to maintain and enhance strength, endurance and flexibility; 3) appropriate use of medications; 4) effective communication with health professionals, family and friends; 5) healthy diet; 6) decision making.The psychoeducational intervention will consist of six weekly, 2.5 hour sessions led by one educator (Ruixue Cao). Each group will consist of up to 12 participants.
During the six weeks' intervention, the participants will received message or phone weekly for reminding them to attend the intervention on time.
The psychoeducational intervention will be held in a community clinic which is convenient for the participants.
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Intervention code [1]
312966
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Lifestyle
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Comparator / control treatment
The control group will receive the usual care only. Usual care refers to services provided at primary care clinics and visits to pulmonary physicians based on referral from general practitioners. The frequency and content of usual care services are not standardised which depends on patients’ needs.
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Control group
Active
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Outcomes
Primary outcome [1]
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symptoms of anxiety
Hospital Anxiety and Depression Scale will be used to assess the symptoms of anxiety.
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Assessment method [1]
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Timepoint [1]
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Symptoms of anxiety will be measured at baseline, immediately after the intervention (Post-test 1), and four weeks after the intervention (Post-test 2).
The primary timepoint will be 6 weeks (end of the intervention period)
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Primary outcome [2]
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symptoms of depression
Hospital Anxiety and Depression Scale will be used to assess the symptoms of depression.
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Assessment method [2]
308180
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Timepoint [2]
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Symptoms of depression will be measured at baseline, immediately after the intervention (Post-test 1), and four weeks after the intervention (Post-test 2).
The primary timepoint will be 6 weeks (end of the intervention period)
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Secondary outcome [1]
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Self-efficacy
COPD Self-efficacy Scale will be used to assess self-efficacy.
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Assessment method [1]
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Timepoint [1]
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Self-efficacy will be measured at baseline, immediately after the intervention (Post-test 1), and four weeks after the intervention (Post-test 2).
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Secondary outcome [2]
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Quality of Life
St George's respiratory questionnera will be used to assess the quality of life of the participants.
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Assessment method [2]
354186
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Timepoint [2]
354186
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Health-related quality of life will be measured at baseline, immediately after the intervention (Post-test 1), and four weeks after the intervention (Post-test 2).
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Eligibility
Key inclusion criteria
Inclusion Criteria
• Male or female outpatients aged 18 years and above with a confirmed diagnosis of COPD (FEV1/FVC <0.70).
• All levels of COPD severity are eligible including mild to moderate and severe to very severe stage.
• Patients are willing to participate in the study and have capacity to provide informed consent.
• Agree to follow the study procedures
• Speak Mandarin
• Able to read and write Chinese
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria
• People with cognitive impairment such as dementia
• People participated in any other clinical trial
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Individuals will be identified from the study hospitals and meet the inclusion criteria. Individuals will be provided with the Participant Information Sheet and contacted 1 week later to determine if they would like to participate.
Partcipants will attend a baseline visit and the relevant outcome measures will be collected. They will then be randomised to either intervention group or the control group.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The participants will be randomly allocated into the intervention and control group using a random number generator software ("www.random.org,"). The participants will be each assigned a number. The researcher will input the first and last numbers into the online random generator, the program will run an algorithm, which will randomly select a number within the range the researcher entered. We will record the numbers, and these participants will be assigned into the intervention group.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Quantitative data analysis will be conducted using IBM® SPSS® Statistics 24, with a 5% significance level (p=0.05). Analysis will follow the intention to treat principles. A descriptive statistical analysis will be performed for all baseline variables of the study. We will calculate the mean, median and standard deviations for quantitative variables, frequencies and percentages will be presented for categorical variables. Summaries will be presented for the total sample and separately by treatment group. To examine whether the psychoeducation intervention improved anxiety and depression over the control group at each follow-up time point, mixed effects models for repeated measures will be estimated. An unstructured covariance matrix will be used to account for serial correlations due to the repeated outcome measurements. Independent variables in the model will include the baseline value of the outcome, treatment group, time and the interaction between treatment group and time. Means and 95% confidence intervals for each treatment group will be presented at each follow-up.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
15/03/2019
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Actual
1/08/2019
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Date of last participant enrolment
Anticipated
1/12/2019
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Actual
30/12/2019
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Date of last data collection
Anticipated
15/02/2020
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Actual
1/03/2020
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Sample size
Target
40
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Accrual to date
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Final
62
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Recruitment outside Australia
Country [1]
21054
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China
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State/province [1]
21054
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Anhui Province
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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The University of Newcastle Research Training Support Funds (RTS)
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Address [1]
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University Drive
Callaghan NSW 2308
Australia
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Country [1]
301238
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Australia
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Primary sponsor type
University
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Name
The University of Newcastle
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Address
University Drive
Callaghan NSW 2308
Australia
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Country
Australia
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Secondary sponsor category [1]
300877
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None
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Name [1]
300877
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Address [1]
300877
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Country [1]
300877
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
301977
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The University of Newcastle Human Research Ethics Committee
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Ethics committee address [1]
301977
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Research & Innovation Services
Research Integrity Unit
The University of Newcastle
Callaghan NSW 2308
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Ethics committee country [1]
301977
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Australia
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Date submitted for ethics approval [1]
301977
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26/02/2018
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Approval date [1]
301977
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18/09/2018
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Ethics approval number [1]
301977
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H-2018-0079
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Summary
Brief summary
The aim of this study is to develop and evaluate the effectiveness of a group psychoeducational intervention on symptoms of anxiety and depression, health-related quality of life and self-efficacy for people with COPD. A pilot single-blind randomised controlled trial will be conducted with randomisation to either a group psychoeducational intervention or usual care. Psychoeducational intervention will be provided to the intervention group, while the control group receive usual care.
The psychoeducational intervention is an adaptation of the Stanford Chronic Disease Self-management Program (CDSMP) developed in the United States. It is a six-week interactive workshop for people with chronic obstructive pulmonary disease.Topics of the psychoeducational intervention covered include: 1)techniques to cope with issues like fatigue, isolation and pain; 2) appropriate exercise aiming to maintain and enhance strength, endurance and flexibility; 3) appropriate use of medications; 4) effective communication with health professionals, family and friends; 5) healthy diet; 6) decision making; 7) how to evaluate new treatment.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Sally Chan
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Address
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Professor Sally Chan
Dean of School
School of Nursing and Midwifery
Faculty of Health and Medicine
RW1-39
Building Richardson Wing
Callaghan
University Drive
Callaghan, NSW 2308
Australia
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Country
88742
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Australia
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Phone
88742
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+61 02 4921 7873
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Fax
88742
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Email
88742
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[email protected]
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Contact person for public queries
Name
88743
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Miss Ruixue Cao
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Address
88743
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Ruixue Cao
Phd Candidate
School of Nursing and Midwifery
Faculty of Health and Medicine
Building Richardson Wing
Callaghan
University Drive
Callaghan, NSW 2308
Australia
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Country
88743
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Australia
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Phone
88743
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+61 0413574672
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Fax
88743
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Email
88743
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[email protected]
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Contact person for scientific queries
Name
88744
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Miss Ruixue Cao
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Address
88744
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Ruixue Cao
Phd Candidate
School of Nursing and Midwifery
Faculty of Health and Medicine
Building Richardson Wing
Callaghan
University Drive
Callaghan, NSW 2308
Australia
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Country
88744
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Australia
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Phone
88744
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+61 0413574672
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Fax
88744
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Email
88744
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
357
Ethical approval
376421-(Uploaded-20-11-2018-15-32-39)-Study-related document.pdf
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF