Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001605280
Ethics application status
Approved
Date submitted
28/08/2018
Date registered
27/09/2018
Date last updated
27/09/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving patient's recall of past events through the use of technology
Scientific title
An investigation of methods to improve recall for the patient reported outcome measurement in COPD patients
Secondary ID [1] 295929 0
nil known
Universal Trial Number (UTN)
U1111-1219-5431
Trial acronym
Recall
Linked study record
n/a

Health condition
Health condition(s) or problem(s) studied:
COPD 309424 0
Condition category
Condition code
Respiratory 308277 308277 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a feasibility study of two approaches to improve recall. These approaches to improve recall will be tested in a single centre, randomised controlled trial comparing alternative methods of assessing change in patient reported outcomes. The control group are patients on the wait listed for the pulmonary rehabilitation program. Clinical staff will be assessing the patients (wait listed) and conducting the pulmonary rehabilitation (PR group)and these clinical staff are unaware of the randomisation of patients to interventions and are not part of the research team or the study. A research assistant will be administering the questionnaires.

Eligible participants will be randomised 1:1:1 assigned ratio to one of the three arms in both the pulmonary rehabilitation and wait list groups using a computer generated randomisation code.

All patients will be completing patient reported insturments i.e St Georges Respiratory Questionnaire, Hospital Anxiety and Depression Scale, and European Quality of Life.

In the first arm the patients will be videoed at baseline responding to the EQ5D questions and they will review their tablet computer video recording one month later when they complete the same questionnaires.
In the second arm participants will complete the questionaires and they will be shown their baseline responses one month later just prior to completing the questionnaires again.

In the third arm participants will complete the questionnaires at baseline and they will receive no feedback on their baseline responses when they complete the questionnaires again one month later.

(1) Intervention - Tablet computer video recording: Participants will be asked about their responses to the health questionnaires they had just completed on enrolment and this will be video recorded using a table computer. The participant will be video recorded as they respond to the EQ5D questions asked by the RA. The audio-video recording will be stored on a password protected computer. Participants will be shown their audio-visual recording one month later just before they complete the health questionnaires.
Intervention code [1] 312251 0
Other interventions
Comparator / control treatment
The waitlist patients will be assessed for pulmonary rehabilitation by the clinical staff and placed on a wait list. At this point the RA will approach the patients to see if they would consider participating in the Recall Study.

In both the pulmonary rehabilitation and waitlist participants there is an intervention arm of tablet technology and two control arms.

In the waitlist group participants as well as pulmonary rehabilition participants will be randomised to tablet technology, control with access to the baseline responses and control without access to previous responses

(1) Control Group - Being shown a hard copy of previous responses: Participants will be shown hard copies of their completed baseline questionnaires immediately prior to completing the follow-up questionnaires.
(2) Control Group - No feedback on baseline questionnaire provided: Participants will be asked to complete the health questionnaires one month after enrolment without access to their previous responses or an audio-visual recording.

Feasibility in this study is concerned with the ease of administration of the interventions and the conduct of the study. Data pertaining to an assessment of feasibility includes:
• The willingness of clinicians to refer patients to the study,
• The willingness of participants to be involved in the study,
• The number of eligible patients,
• The drop-out rates,
• The follow-up rates,
• Acceptability of being video recorded as measured by standardised open ended question,
• The length of time (minutes) needed to administration the questionnaires,
• The length of time (weeks) required to complete data analysis.
Control group
Active

Outcomes
Primary outcome [1] 307241 0
Demonstration of the feasibility of using tablet technology

Feasibility of conducting this research in a clinical environment evaluated by using the NIHR NHS criteria:

• The willingness of clinicians to refer patients to the study,
• The willingness of participants to be involved in the study,
• The number of eligible patients,
• The drop-out rates,
• The follow-up rates,
• Acceptability of being video recorded as measured by standardised open ended question,
• The length of time (minutes) needed to administration the questionnaires,
Timepoint [1] 307241 0
one month after baseline completion of questionnaires
Secondary outcome [1] 351912 0
Demonstration of the relative responsiveness of the PROs administered using tablet technology compared with current accepted approaches to reduce recall bias.

We will measure the within-subject change in PRO scores over the one month period. The difference in mean change between those who had pulmonary rehabilitation and those who remained on the waiting list over this one month period will be calculated. Finally, the magnitude of this difference (responsiveness) will be compared between the three randomised groups.
Timepoint [1] 351912 0
one month after baseline completion of the final enrolled participant's questionaires and end of study will be achieved when 15 pulmonary rehabilitation participants have completed the questionnaires at one month follow-up and the Waitlist participants (15 in total) have completed their questionnaires at their one month follow-up

Eligibility
Key inclusion criteria
Inclusion criteria
1. Must be medically diagnosed with COPD
2. Must be either wait listed for pulmonary rehabilitation or commencing pulmonary rehabilitation
3. Must have reasonable hearing with or without a hearing device
4. Must be able to read to year 7 (newspaper level) to ensure understanding of questions in questionnaires.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria
1. Must not have significant medical co-morbidities that require acute ongoing care
2. Must not have significant neurological and or cognition dysfunction such as medically diagnosed dementia

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)
Patients are approached and enrolled by research assistants in the clinical area according to the assignment order generated prior to the commencement of the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible participants will be randomised 1:1:1 assigned ratio to one of the three arms in both the pulmonary rehabilitation and wait list groups using a computer generated randomisation code. The randomisation code was generated by the statistician and was sent directly to the research assistant. The investigators did not receive the randomisation code.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
single blind (patient only). Patients are individually interviewed in a office away from other participants.
Tablet technology participants will be asked their EQ5D questions only and they will not have access to any other information from questionnaires such as SGRQ and HADS they previously completed.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Demographic and clinical information will be assessed using descriptive statistics measuring frequencies, means and standard deviations. We will measure within-subject change in the patient reported outcome scores over the one month period. The difference in mean change between those who had pulmonary rehabilitation and those who remained on the waitlist over this one month period will be calculated. Finally, the magnitude of this difference (responsiveness) will be compared between the three randomised groups. Our hypothesis is that the magnitude of the difference (responsiveness) will be greatest in those who saw the audio-visual recording. The feasibility assessment will be reported using descriptive statistics.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/08/2016
Date of last participant enrolment
Anticipated
30/11/2018
Actual
Date of last data collection
Anticipated
4/01/2019
Actual
Sample size
Target
30
Accrual to date
23
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 11746 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 23829 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 300527 0
University
Name [1] 300527 0
Western Sydney University Professor Sheree Smith discretionary fund
Country [1] 300527 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
Western Sydney University
Locked Bag 1797,
Penrith, NSW 2751
Country
Australia
Secondary sponsor category [1] 300004 0
None
Name [1] 300004 0
Address [1] 300004 0
Country [1] 300004 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301315 0
South Western Sydney Local Health District Research & Ethics Committee
Ethics committee address [1] 301315 0
Ethics committee country [1] 301315 0
Australia
Date submitted for ethics approval [1] 301315 0
21/08/2014
Approval date [1] 301315 0
18/09/2014
Ethics approval number [1] 301315 0
LNR/14/LPOOL/383

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86606 0
Prof Sheree Smith
Address 86606 0
School of Nursing and Midwifery,
Western Sydney University,
Locked bag 1797
Penrith 2751 NSW
Country 86606 0
Australia
Phone 86606 0
+61 (2) 46203532
Fax 86606 0
+61 (2) 46203161
Email 86606 0
[email protected]
Contact person for public queries
Name 86607 0
Sheree Smith
Address 86607 0
School of Nursing and Midwifery,
Western Sydney University,
Locked bag 1797
Penrith 2751 NSW
Country 86607 0
Australia
Phone 86607 0
+61 (2) 46203532
Fax 86607 0
+61 (2) 46203161
Email 86607 0
[email protected]
Contact person for scientific queries
Name 86608 0
Sheree Smith
Address 86608 0
School of Nursing and Midwifery,
Western Sydney University,
Locked bag 1797
Penrith 2751 NSW
Country 86608 0
Australia
Phone 86608 0
+61 (2) 46203532
Fax 86608 0
+61 (2) 46203161
Email 86608 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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