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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
22/11/2018
Date data sharing statement initially provided
22/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Education Program for people with Chronic Obstructive Pulmonary Disease
Scientific title
Evaluation of a psychoeducational intervention for people with chronic obstructive pulmonary disease: a mixed methods study
Secondary ID [1] 296658 0
None
Universal Trial Number (UTN)
U1111-1224-2740
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic obstructive pulmonary disease 310494 0
symptoms of anxiety
310496 0
symptoms of depression 310497 0
Condition category
Condition code
Respiratory 309204 309204 0 0
Chronic obstructive pulmonary disease
Mental Health 309205 309205 0 0
Anxiety
Mental Health 309206 309206 0 0
Depression

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 312966 0
Lifestyle
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.
Control group
Active

Outcomes
Primary outcome [1] 308179 0
symptoms of anxiety
Hospital Anxiety and Depression Scale will be used to assess the symptoms of anxiety.
Timepoint [1] 308179 0
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)
Primary outcome [2] 308180 0
symptoms of depression
Hospital Anxiety and Depression Scale will be used to assess the symptoms of depression.
Timepoint [2] 308180 0
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)
Secondary outcome [1] 354185 0
Self-efficacy
COPD Self-efficacy Scale will be used to assess self-efficacy.
Timepoint [1] 354185 0
Self-efficacy will be measured at baseline, immediately after the intervention (Post-test 1), and four weeks after the intervention (Post-test 2).
Secondary outcome [2] 354186 0
Quality of Life
St George's respiratory questionnera will be used to assess the quality of life of the participants.
Timepoint [2] 354186 0
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).

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria
• People with cognitive impairment such as dementia
• People participated in any other clinical trial

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
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.
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21054 0
China
State/province [1] 21054 0
Anhui Province

Funding & Sponsors
Funding source category [1] 301238 0
University
Name [1] 301238 0
The University of Newcastle Research Training Support Funds (RTS)
Address [1] 301238 0
University Drive
Callaghan NSW 2308
Australia
Country [1] 301238 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Drive
Callaghan NSW 2308
Australia
Country
Australia
Secondary sponsor category [1] 300877 0
None
Name [1] 300877 0
Address [1] 300877 0
Country [1] 300877 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301977 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 301977 0
Research & Innovation Services
Research Integrity Unit
The University of Newcastle
Callaghan NSW 2308
Ethics committee country [1] 301977 0
Australia
Date submitted for ethics approval [1] 301977 0
26/02/2018
Approval date [1] 301977 0
18/09/2018
Ethics approval number [1] 301977 0
H-2018-0079

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88742 0
Prof Sally Chan
Address 88742 0
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
Country 88742 0
Australia
Phone 88742 0
+61 02 4921 7873
Fax 88742 0
Email 88742 0
Sally.chan@newcastle.edu.au
Contact person for public queries
Name 88743 0
Miss Ruixue Cao
Address 88743 0
Ruixue Cao
Phd Candidate
School of Nursing and Midwifery
Faculty of Health and Medicine
Building Richardson Wing
Callaghan
University Drive
Callaghan, NSW 2308
Australia
Country 88743 0
Australia
Phone 88743 0
+61 0413574672
Fax 88743 0
Email 88743 0
c3213212@uon.edu.au
Contact person for scientific queries
Name 88744 0
Miss Ruixue Cao
Address 88744 0
Ruixue Cao
Phd Candidate
School of Nursing and Midwifery
Faculty of Health and Medicine
Building Richardson Wing
Callaghan
University Drive
Callaghan, NSW 2308
Australia
Country 88744 0
Australia
Phone 88744 0
+61 0413574672
Fax 88744 0
Email 88744 0
c3213212@uon.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 357 0
Ethical approval
Citation [1] 357 0
Link [1] 357 0
Email [1] 357 0
Other [1] 357 0
Summary results
No Results