Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12615000259549
Ethics application status
Approved
Date submitted
6/02/2015
Date registered
19/03/2015
Date last updated
4/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Using robots to reduce hospitalisations in patients with Chronic Obstructive Pulmonary Disease (COPD).
Scientific title
Using robots to reduce hospitalisations in patients with Chronic Obstructive Pulmonary Disease (COPD).
Secondary ID [1] 286117 0
nil
Universal Trial Number (UTN)
U1111-1164-5293
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COPD 294118 0
Condition category
Condition code
Respiratory 294433 294433 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is in the form of a robot that reminds people to take medication and do exercises, and measures spirometry, weight, pulse oxygen, self-reported health, and feeds this information to a health professional monitoring this data who responds if necessary to prevent exacerbations. The duration of the intervention is 4 months. The robot sits in the home of the patient - it is not carried around. The frequency of the medication reminders depends on the individual patient but for most patients will be twice daily. The other measures will be daily for the first 3 days and weekly after that. Data from the robot goes to a secure server that can be accessed by the healthcare team. The activity monitors are worn on the wrist to measure exercise. This information is also linked with the robot and the secure server so the healthcare team can monitor adherence to exercise regimes. The smart inhaler data can also be viewed on a secure server by the healthcare team to monitor inhaler use and adherence. In addition, adherence is measured as self-reports both on the robot and by questionnaire at the start and end of the study. The smartphone provides a link between the robot, smartinhaler and the server and allows contact between the patient and the healthcare team.
Intervention code [1] 291115 0
Treatment: Other
Comparator / control treatment
Standard care is health care that would normally be provided if the participant was not in the trial (for example usual care from the general practitioner, hospital inpatient and outpatient services, rehabilitation programme)
Control group
Active

Outcomes
Primary outcome [1] 294230 0
Number of days of hospitalisation assessed from patient medical records
Timepoint [1] 294230 0
4 months from randomisation
Secondary outcome [1] 312842 0
adherence measured by smart inhalers and self-reports on the robot and in questionnaires (Medication Adherence Report Scale)
Timepoint [1] 312842 0
4 months from randomisation
Secondary outcome [2] 312843 0
loneliness using the UCLA Loneliness Scale
Timepoint [2] 312843 0
4 months from randomisation
Secondary outcome [3] 312844 0
Mental health using the Clinical COPD questionnaire mental health subscale and the COPD Anxiety Questionnaire and the PHQ-9.
Timepoint [3] 312844 0
4 months from randomisation
Secondary outcome [4] 312845 0
Functional status will be assessed using the Clinical COPD Questionnaire function subscale.
Timepoint [4] 312845 0
4 months from randomisation
Secondary outcome [5] 312846 0
Use of healthcare (nurse and physio visits and phone calls) via a log with COPD services.
Timepoint [5] 312846 0
4 months from randomisation
Secondary outcome [6] 313471 0
Self efficacy for managing chronic disease 6-item scale from Stanford Patient Education Research center
Timepoint [6] 313471 0
4 months from randomisation
Secondary outcome [7] 313472 0
Illness Perceptions measured with the Brief Illness Perception Questionnaire
Timepoint [7] 313472 0
4 months from randomisation
Secondary outcome [8] 313473 0
Perceptions of robots (intervention group only) assessed with the Robot Attitude Scale as well as interviews
Timepoint [8] 313473 0
4 months from randomisation

Eligibility
Key inclusion criteria
Inclusion Criteria:
1. Confirmed diagnosis of COPD and FEV1<60% predicted
2. COPD main cause of admission
3. Previous admission(s) in past year with COPD
4. Gets out of house <4 times/week (shopping, seeing friends)
5. Living alone (or with spouse but who is also largely housebound)
6. Geographic rural location (>5 km from town) e.g. Awhitu Peninsula, Glenbrook, Maraetai etc. Towns = Waiuku, Pukekohe, Papakura, Howick,
7. Poor social support (visit by friends/family <1/week) and
8. High levels of anxiety on the Clinical COPD Questionnaire (CCQ).
(Criteria 1-3 mandatory, minimum of 2 of criteria 4-8 mandatory)
Minimum age
16 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Increased BNP or troponin level on admission (predicts increased risk of death in subsequent 6 months)
2. CURB65 score >2 (similar)
3. Life expectancy <1 year
4. Diagnosis of incurable Cancer
5. Comorbid condition causing greater impact on quality of life than COPD e.g. severe CCF, CVA
6. Residence in rest home
7. Living with family/friends
8. Age >90
9. Still working (unless from home).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential patients will be identified at hospital discharge and outpatient clinics at Counties Manukau, Gore Health and Southland DHBs. Eligible patients will be invited to take part in the trial and written informed consent will be obtained. They will be unaware to which group the subject will be allocated to. Allocation will involve contacting the holder of the allocation schedule who will be off site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
60 participants will be block randomised (by site, Gore/Southland or Middlemore) after completion of baseline data collection to either the robot or the control group, by a distant researcher not connected to recruitment. We will use stratified randomisation to match groups for ethnicity and gender.
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
Analysis will be performed by a researcher blinded to group allocation. Survival analysis will test the impact of the strategies on time to hospitalisation. Regression models (taking into account repeated measures) will be used to compare groups on functioning, adherence, mental state and loneliness, and baseline measurements will be taken into account. The difference in days of hospitalisation, and length of stay will be compared between groups. We will perform subgroup analysis based on ethnicity and control for socio- economic status and number of comorbidities (CCF, PH IHD, CVA, Diabetes). Analysis will be carried out using SPSS and SAS.
We aim to conduct a study based on a sample size that will provide useful indications of cost- and clinical effectiveness. A NZ trial showed that case management for 16 patients with at least 4 admissions over the previous 2 years for COPD, reduced number of admissions and length of stay compared to control patients 15. Median length of stay was 5.8 days for the control group and 3.5 days for the intervention group. Using a standard deviation of 2 days, this is an effect size of 1.15. It is hypothesised that telehealth will have a similar effect on hospitalization days. The required sample size is 16 patients per group (intervention/control) with a significance of .05 and power of .90. To allow for a subgroup analysis by ethinic group will aim to recruit 60 patients in total.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/05/2015
Actual
1/08/2015
Date of last participant enrolment
Anticipated
Actual
20/02/2016
Date of last data collection
Anticipated
Actual
1/07/2016
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 6632 0
New Zealand
State/province [1] 6632 0
Auckland

Funding & Sponsors
Funding source category [1] 290697 0
Government body
Name [1] 290697 0
Helath Research Council of New Zealand
Country [1] 290697 0
New Zealand
Primary sponsor type
University
Name
The business arm of the University of Auckland (Uniservices Ltd)
Address

Level 10,
UniServices House, Auckland
70 Symonds Street, Auckland
1142
NZ
Country
New Zealand
Secondary sponsor category [1] 289389 0
Individual
Name [1] 289389 0
Elizabeth Broadbent
Address [1] 289389 0
Dept Psychological Medicine
The University of Auckland
Private Bag 92019
Auckland 1142
Country [1] 289389 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292334 0
Health and Disability Ethics Committees
Ethics committee address [1] 292334 0
Ministry of Health C/- MEDSAFE, Level 6, Deloitte House 10 Brandon Street PO Box 5013 Wellington 6011
Ethics committee country [1] 292334 0
New Zealand
Date submitted for ethics approval [1] 292334 0
26/11/2014
Approval date [1] 292334 0
24/12/2014
Ethics approval number [1] 292334 0
14/NTA/229

Summary
Brief summary
The objective is to investigate whether new technologies can reduce days of hospitalisation for high-risk patients with COPD. A randomised controlled trial will be conducted with Counties Manukau DHB, Southland DHB and Gore Health. Sixty participants will be randomised to receive either standard care, or standard care plus a robot. The robot will be programmed to provide medication management, telemedicine, spirometer readings and blood oxygen monitoring, monitoring of activity using wearable activity sensors, COPD questionnaires, and be linked to Smart inhaler devices to monitor adherence. The data from the robot and smart inhalers will be monitored and if the early signs of an exacerbation are detected, appropriate treatment will be provided to patients. The hypotheses are that telehealthcare (the robot) will reduce hospital admissions and bed-care days compared to a control group, as well as improvements in mental health, loneliness, and adherence. This research will deliver information about the clinical- and cost-effectiveness of these technologies to inform COPD care.
Trial website
nil
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54706 0
Dr Elizabeth Broadbent
Address 54706 0
Senior Lecturer in Health Psychology
Dept of Psychological Medicine
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country 54706 0
New Zealand
Phone 54706 0
+64 9 3737599
Fax 54706 0
Email 54706 0
[email protected]
Contact person for public queries
Name 54707 0
Dr Elizabeth Broadbent
Address 54707 0
Senior Lecturer in Health Psychology
Dept of Psychological Medicine
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country 54707 0
New Zealand
Phone 54707 0
+ 64 9 3737599
Fax 54707 0
Email 54707 0
[email protected]
Contact person for scientific queries
Name 54708 0
Dr Elizabeth Broadbent
Address 54708 0
Senior Lecturer in Health Psychology
Dept of Psychological Medicine
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country 54708 0
New Zealand
Phone 54708 0
+64 9 3737599
Fax 54708 0
Email 54708 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.